Clinical trial • Phase II • Gastroenterology
MT-501 for Crohn's disease | Ulcerative colitis
Phase II trial of MT-501 for Crohn's disease | Ulcerative colitis.
Overview
- Trial Therapeutic Area
- Gastroenterology
- Trial Disease
- Crohn's disease | Ulcerative colitis
- Trial Stage
- Phase II
- Drug Modality
- Small molecule | Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 07-07-2025
- First CTIS Authorization Date
- 20-10-2025
Trial design
Randomised, placebo for mt-501, film coated tablets (dose and schedule not specified)-controlled Phase II trial in Belgium, Italy, Bulgaria and others.
- Randomised
- Yes
- Comparator
- Placebo for MT-501, film coated tablets (dose and schedule not specified)
Eligibility
Recruits 54 Vulnerable population selected. Participants must be able to provide written informed consent and understand and comply with study requirements; legal or mental incapacitation or inability to understand and comply is an exclusion. Prisoners/compulsorily detained participants are explicitly excluded..
- Pregnancy Exclusion
- Women who are pregnant or breastfeeding.
- Vulnerable Population
- Vulnerable population selected. Participants must be able to provide written informed consent and understand and comply with study requirements; legal or mental incapacitation or inability to understand and comply is an exclusion. Prisoners/compulsorily detained participants are explicitly excluded.
Inclusion criteria
- {"criterion_text":"- ≥ 18 to ≤ 80 years old.\n- UC: Moderately to severely active UC.\n- UC: Participants must meet drug stabilization requirements.\n- Able to provide written informed consent and understand and comply with the requirements of the study specified both in the Master Protocol and the ISA.\n- Participants must have had insufficient response and/or intolerance to corticosteroid, immunosuppressants, and/or an approved advanced therapy for UC or CD.\n- Female participants must be of non-childbearing potential or have a negative serum pregnancy test at time of Screening if of childbearing potential. Additional requirements for birth control methods apply for each ISA.\n- CD: Documented diagnosis of CD.\n- CD: Moderately to severely active CD as defined by CDAI.\n- CD: SES-CD (per central reading) consistent with moderate to severely active CD.\n- CD: Participants must meet drug stabilization requirements.\n- UC: Documented diagnosis of UC."}
Exclusion criteria
- {"criterion_text":"- Women who are pregnant or breastfeeding.\n- Participants with any serious bacterial infection within 3 months prior to Screening.\n- Positive stool polymerase chain reaction (PCR) or culture for enteric pathogens.\n- Stool positive for Clostridioides difficile (C. difficile) infection.\n- Clinically significantly abnormal laboratory values.\n- Prisoners or participants who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (eg, infectious disease) illness.\n- Legal or mental incapacitation, or inability to understand and comply with the requirements of the study.\n- Allergy to intervention or any of the excipients.\n- CD patients: Diagnosis of indeterminate colitis.\n- CD patients: Suspected or diagnosed intra-abdominal or perianal abscess at Screening.\n- CD patients: Current stoma or impending need for ostomy or participants with ileo-anal pouch.\n- Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis.\n- CD patients: Previous small bowel resection with combined resected length of > 100 cm or previous colonic resection of > 2 segments.\n- CD patients: CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement.\n- UC patients: Current evidence or within recent history (within last 6 months) of fulminant colitis, toxic megacolon, or bowel perforation.\n- UC patients: Previous total proctocolectomy or subtotal colectomy.\n- Past or current evidence of definite low-grade or high-grade colonic dysplasia that has not been completely removed.\n- Participants who are scheduled or anticipate the need for surgery, aside from dermatologic or other minor outpatient procedures.\n- Participants who have a known history of clinically significant drug or alcohol abuse, in the opinion of the Investigator.\n- Current symptoms of severe, progressive, or uncontrolled system disease. Concomitant medical conditions that, in the opinion of the Investigator, might place the participant at unacceptable risk for participation in this study.\n- Participants with concomitant primary sclerosing cholangitis.\n- Participants with a history of cancer within the 5 years prior to Screening (other than non-melanoma skin cell cancers cured by local resection).\n- Participants at risk for tuberculosis (TB)."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Proportion of participants reporting treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events (AEs) leading to discontinuation, and markedly abnormal laboratory values","definition_or_measurement_approach":"Assess proportion of participants reporting TEAEs, SAEs, AEs leading to discontinuation, and markedly abnormal laboratory values (as reported during study follow-up)."}
- {"endpoint_text":"- Prospective Observer-Blinded Endpoint ISAs: CD: Proportion of participants with endoscopic response at end of Induction Phase UC: Proportion of participants with endoscopic improvement at end of Induction Phase","definition_or_measurement_approach":"Assess the proportion of participants with endoscopic response (CD) or endoscopic improvement (UC) at end of Induction Phase using prospective observer-blinded endpoint assessments."}
- {"endpoint_text":"- Randomized Placebo-Controlled ISAs: Proportion of participants with clinical remission at end of Induction Phase","definition_or_measurement_approach":"Assess the proportion of participants with clinical remission at end of Induction Phase in randomized placebo-controlled ISAs."}
Secondary endpoints
- {"endpoint_text":"- Proportion of participants with clinical remission at end of Induction Phase","definition_or_measurement_approach":"Assess proportion of participants with clinical remission at end of Induction Phase."}
- {"endpoint_text":"- CD: Proportion of participants with endoscopic response at end of Induction Phase UC: Proportion of participants with endoscopic improvement at end of Induction Phase","definition_or_measurement_approach":"Assess proportion with endoscopic response (CD) or endoscopic improvement (UC) at end of Induction Phase."}
- {"endpoint_text":"- Proportion of participants with Patient-Reported Outcome-2 (PRO-2) remission at end of Induction Phase","definition_or_measurement_approach":"Assess proportion of participants achieving PRO-2 remission at end of Induction Phase."}
- {"endpoint_text":"- Proportion of participants with clinical response at end of Induction Phase","definition_or_measurement_approach":"Assess proportion of participants with clinical response at end of Induction Phase."}
- {"endpoint_text":"- CD: Proportion of participants with endoscopic and clinical response at end of Induction Phase","definition_or_measurement_approach":"Assess proportion of CD participants with both endoscopic and clinical response at end of Induction Phase."}
- {"endpoint_text":"- UC: Proportion of participants with histologic response at end of Induction Phase","definition_or_measurement_approach":"Assess proportion of UC participants with histologic response at end of Induction Phase."}
- {"endpoint_text":"- UC: Proportion of participants with histologic remission at end of Induction Phase","definition_or_measurement_approach":"Assess proportion of UC participants with histologic remission at end of Induction Phase."}
- {"endpoint_text":"- UC: Proportion of participants with histologic-endoscopic mucosal improvement at end of Induction Phase","definition_or_measurement_approach":"Assess proportion of UC participants with combined histologic-endoscopic mucosal improvement at end of Induction Phase."}
- {"endpoint_text":"- CD: Change in SES-CD from Day 1 to end of Induction Phase UC: Change in MES from Day 1 to end of Induction Phase","definition_or_measurement_approach":"Characterize change in endoscopy scores (SES-CD for CD; MES for UC) from Day 1 to end of Induction Phase."}
- {"endpoint_text":"- CD: Change in Global Histologic Activity Score (GHAS) and RHI from Day 1 to end of Induction Phase UC: Change in Geboes score, RHI, and Nancy Histological Index (NHI) from Day 1 to end of Induction Phase Descriptive summaries of PK of investigational drug","definition_or_measurement_approach":"Characterize change in histology scores (GHAS, RHI for CD; Geboes, RHI, NHI for UC) from Day 1 to end of Induction Phase; includes descriptive PK summaries."}
- {"endpoint_text":"- Descriptive summaries of PK of investigational drug","definition_or_measurement_approach":"Provide descriptive summaries of pharmacokinetics (PK) of investigational drug."}
Recruitment
- Planned Sample Size
- 54
- Recruitment Window Months
- 18
- Consent Approach
- Written informed consent is required; participants must be able to provide written informed consent and understand study requirements. Subject information sheets and informed consent forms are provided (multiple language / country-specific versions are listed in the documentation: examples include EN, BG, CZ, DE, IT, SK, PL, BE-FR, BE-NL, HR). Only adults (≥18 years) are eligible; no assent procedures are indicated.
Methods
- Physician-to-physician referral letters (documented in recruitment materials K2_Physician to Physician Referral Letter).
- Patient referral contact letters (K2_Recruitment material description_Patient Referral Contact letter).
- GP letters (L2_Other subject information_GP Letter_Redacted).
- Recruitment and Informed Consent Procedure documents (K1_Recruitment and Informed consent procedure) provided per Member State.
Geography
- Total Number Of Sites
- 40
- Total Number Of Participants
- 54
Belgium
- Earliest CTIS Part Ii Submission Date
- 22-09-2025
- Latest Decision Or Authorization Date
- 04-05-2026
- Processing Time Days
- 224
- Number Of Sites
- 3
- Number Of Participants
- 3
Sites
- Site Name
- Imelda
- Department Name
- Gastroenterology
- Principal Investigator Name
- Peter Bossuyt
- Principal Investigator Email
- peter.bossuyt@imelda.be
- Contact Person Name
- Peter Bossuyt
- Contact Person Email
- peter.bossuyt@imelda.be
- Site Name
- UZ Leuven
- Department Name
- Gastroenterology
- Principal Investigator Name
- Bram Verstockt
- Principal Investigator Email
- bram.verstockt@uzleuven.be
- Contact Person Name
- Bram Verstockt
- Contact Person Email
- bram.verstockt@uzleuven.be
- Site Name
- University Of Antwerp
- Department Name
- Gastroenterology/Hepatology
- Principal Investigator Name
- Elisabeth Macken
- Principal Investigator Email
- elisabeth.macken@uza.be
- Contact Person Name
- Elisabeth Macken
- Contact Person Email
- elisabeth.macken@uza.be
Italy
- Earliest CTIS Part Ii Submission Date
- 15-10-2025
- Latest Decision Or Authorization Date
- 05-05-2026
- Processing Time Days
- 202
- Number Of Sites
- 4
- Number Of Participants
- 5
Sites
- Site Name
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
- Department Name
- Department of Medical Sciences, SC Gastroenterology Unit
- Principal Investigator Name
- Ribaldone Davide Giuseppe
- Principal Investigator Email
- davidegiuseppe.ribaldone@unito.it
- Contact Person Name
- Ribaldone Davide Giuseppe
- Contact Person Email
- davidegiuseppe.ribaldone@unito.it
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- Operative Unit Inflammatory Bowel Diseases
- Principal Investigator Name
- Alessandro Armuzzi
- Principal Investigator Email
- alessandro.armuzzi@hunimed.eu
- Contact Person Name
- Alessandro Armuzzi
- Contact Person Email
- alessandro.armuzzi@hunimed.eu
- Site Name
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Department Name
- UOC CEMAD - Center for Digestive System Diseases
- Principal Investigator Name
- Lucrezia Laterza
- Principal Investigator Email
- lucrezia.laterza@policlinicogemelli.it
- Contact Person Name
- Lucrezia Laterza
- Contact Person Email
- lucrezia.laterza@policlinicogemelli.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Department of Gastroenterology and Gastrointestinal Endoscopy
- Principal Investigator Name
- Silvio Danese
- Principal Investigator Email
- DANESE.SILVIO@HSR.IT
- Contact Person Name
- Silvio Danese
- Contact Person Email
- DANESE.SILVIO@HSR.IT
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 16-10-2025
- Latest Decision Or Authorization Date
- 11-05-2026
- Processing Time Days
- 207
- Number Of Sites
- 3
- Number Of Participants
- 4
Sites
- Site Name
- Diagnostic Consultation Center XX-Sofia EOOD
- Principal Investigator Name
- Dimitar Dimitrov
- Principal Investigator Email
- dr.dimitar.dimitrov.md@gmail.com
- Contact Person Name
- Dimitar Dimitrov
- Contact Person Email
- dr.dimitar.dimitrov.md@gmail.com
- Site Name
- Purva Chastna Mbal EOOD Vratsa
- Department Name
- Department of Internal Medicine
- Principal Investigator Name
- Dobromir Dragoychev
- Principal Investigator Email
- dr_dragoichev@abv.bg
- Contact Person Name
- Dobromir Dragoychev
- Contact Person Email
- dr_dragoichev@abv.bg
- Site Name
- Multiprofile Hospital For Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD
- Department Name
- First Department of Internal Medicine
- Principal Investigator Name
- Ilko Kosturkov
- Principal Investigator Email
- ikosturkov@mcmedicaplus.com
- Contact Person Name
- Ilko Kosturkov
- Contact Person Email
- ikosturkov@mcmedicaplus.com
Germany
- Earliest CTIS Part Ii Submission Date
- 17-10-2025
- Latest Decision Or Authorization Date
- 04-05-2026
- Processing Time Days
- 199
- Number Of Sites
- 5
- Number Of Participants
- 6
Sites
- Site Name
- Krankenhaus Waldfriede e.V.
- Department Name
- Innere Medizin
- Principal Investigator Name
- Carsten Buening
- Principal Investigator Email
- c.buening@waldfriede.de
- Contact Person Name
- Carsten Buening
- Contact Person Email
- c.buening@waldfriede.de
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Medizinische Klinik I
- Principal Investigator Name
- Karsten Bueringer
- Principal Investigator Email
- zks-pm@med.uni-tuebingen.de
- Contact Person Name
- Karsten Bueringer
- Contact Person Email
- zks-pm@med.uni-tuebingen.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie
- Principal Investigator Name
- Christoph Jochum
- Principal Investigator Email
- christoph.jochum@charite.de
- Contact Person Name
- Christoph Jochum
- Contact Person Email
- christoph.jochum@charite.de
- Site Name
- Universitaetsklinikum Ulm AöR
- Department Name
- Centre for Internal Medicine, Internal Medicine 1
- Principal Investigator Name
- Jochen Klaus
- Principal Investigator Email
- jochen.klaus@uniklinik-ulm.de
- Contact Person Name
- Jochen Klaus
- Contact Person Email
- jochen.klaus@uniklinik-ulm.de
- Site Name
- Magen-Darm-Zentrum-Remscheid
- Principal Investigator Name
- Eric Joergensen
- Principal Investigator Email
- info@mdz-remscheid.de
- Contact Person Name
- Eric Joergensen
- Contact Person Email
- info@mdz-remscheid.de
Slovakia
- Earliest CTIS Part Ii Submission Date
- 15-10-2025
- Latest Decision Or Authorization Date
- 27-04-2026
- Processing Time Days
- 194
- Number Of Sites
- 2
- Number Of Participants
- 5
Sites
- Site Name
- Endomed s.r.o.
- Department Name
- Gastroenterologická ambulancia
- Principal Investigator Name
- Miroslav Fedurco
- Principal Investigator Email
- fedurco@endomed.sk
- Contact Person Name
- Miroslav Fedurco
- Contact Person Email
- fedurco@endomed.sk
- Site Name
- F D Roosevelt University General Hospital Of Banska Bystrica
- Department Name
- II. interná klinika, gastroenterologická ambulancia
- Principal Investigator Name
- Jozef Baláž
- Principal Investigator Email
- balaz78@gmail.com
- Contact Person Name
- Jozef Baláž
- Contact Person Email
- balaz78@gmail.com
Poland
- Earliest CTIS Part Ii Submission Date
- 16-10-2025
- Latest Decision Or Authorization Date
- 30-04-2026
- Processing Time Days
- 196
- Number Of Sites
- 16
- Number Of Participants
- 21
Sites
- Site Name
- Vistamed & Vertigo Sp. z o.o.
- Department Name
- Vistamed
- Principal Investigator Name
- Bernardeta Fryśna
- Principal Investigator Email
- b.frysna@vistamed.pl
- Contact Person Name
- Bernardeta Fryśna
- Contact Person Email
- b.frysna@vistamed.pl
- Site Name
- Ośrodek Badań Klinicznych CLINSANTE S.C. Ewa Galczak-Nowak Małgorzata Trzaska
- Principal Investigator Name
- Michał Walczak
- Principal Investigator Email
- michal.walczak@clinsante.pl
- Contact Person Name
- Michał Walczak
- Contact Person Email
- michal.walczak@clinsante.pl
- Site Name
- EMC Instytut Medyczny S.A.
- Department Name
- PRYWATNA LECZNICA "CERTUS" SZPITAL NR 1; PRYWATNA LECZNICA CERTUS AMBULATORIA
- Principal Investigator Name
- Piotr Szabłowski
- Principal Investigator Email
- szapi@mp.pl
- Contact Person Name
- Piotr Szabłowski
- Contact Person Email
- szapi@mp.pl
- Site Name
- Vivamed Sp. z o.o.
- Principal Investigator Name
- Robert Petryka
- Principal Investigator Email
- robert@petrykamed.com
- Contact Person Name
- Robert Petryka
- Contact Person Email
- robert@petrykamed.com
- Site Name
- Vita Longa Sp. z o.o.
- Department Name
- NZOZ Vita Longa
- Principal Investigator Name
- Przemysław Ramos
- Principal Investigator Email
- przemyslaw.ramos@researchsolutions.pl
- Contact Person Name
- Przemysław Ramos
- Contact Person Email
- przemyslaw.ramos@researchsolutions.pl
- Site Name
- Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.
- Department Name
- Twoja Przychodnia SCM
- Principal Investigator Name
- Beata Gawdis-Wojnarska
- Principal Investigator Email
- scm@twojaprzychodnia.com
- Contact Person Name
- Beata Gawdis-Wojnarska
- Contact Person Email
- scm@twojaprzychodnia.com
- Site Name
- EMC Instytut Medyczny S.A. (Wroclaw site)
- Department Name
- Penta Hospitals Przychodnie, Wrocław Wejherowska
- Principal Investigator Name
- Patryk Smoliński
- Principal Investigator Email
- psmolinski@poczta.onet.pl
- Contact Person Name
- Patryk Smoliński
- Contact Person Email
- psmolinski@poczta.onet.pl
- Site Name
- Medical Network Sp. z o.o.
- Department Name
- WIP Warsaw IBD Point Profesor Kierkuś
- Principal Investigator Name
- Jarosław Kierkuś
- Principal Investigator Email
- j.kierkus@med-net.pl
- Contact Person Name
- Jarosław Kierkuś
- Contact Person Email
- j.kierkus@med-net.pl
- Site Name
- Centrum Medyczne Oporow
- Principal Investigator Name
- Radosław Kempiński
- Principal Investigator Email
- radoslaw.kempinski@cmoporow.com
- Contact Person Name
- Radosław Kempiński
- Contact Person Email
- radoslaw.kempinski@cmoporow.com
- Site Name
- Melita Medical Sp. z o.o.
- Department Name
- CENTRUM MEDYCZNE MELITA MEDICAL
- Principal Investigator Name
- Jarosław Leszczyszyn
- Principal Investigator Email
- j.leszczyszyn@melitamedical.pl
- Contact Person Name
- Jarosław Leszczyszyn
- Contact Person Email
- j.leszczyszyn@melitamedical.pl
- Site Name
- Manermed Sp. z o.o.
- Department Name
- Centrum Medyczne Medis
- Principal Investigator Name
- Maria Kłopocka
- Principal Investigator Email
- mariaklopocka@cm-medis.pl
- Contact Person Name
- Maria Kłopocka
- Contact Person Email
- mariaklopocka@cm-medis.pl
- Site Name
- Eb Group Sp. z o.o.
- Department Name
- Centrum Zdrowia MDM
- Principal Investigator Name
- Miłosz Jastrzębski
- Principal Investigator Email
- milosz.jastrzebski@czmdm.pl
- Contact Person Name
- Miłosz Jastrzębski
- Contact Person Email
- milosz.jastrzebski@czmdm.pl
- Site Name
- Centrum Medyczne Med-Gastr Sp. z o.o.
- Principal Investigator Name
- Arkadiusz Mamos
- Principal Investigator Email
- amamos@wp.pl
- Contact Person Name
- Arkadiusz Mamos
- Contact Person Email
- amamos@wp.pl
- Site Name
- Endoskopia Sp. z o.o.
- Principal Investigator Name
- Marek Horyński
- Principal Investigator Email
- badanie.kliniczne@wp.pl
- Contact Person Name
- Marek Horyński
- Contact Person Email
- badanie.kliniczne@wp.pl
- Site Name
- Nowe Zdrowie-Ck Kieltucki I Wspolnicy Sp. j.
- Principal Investigator Name
- Jacek Kiełtucki
- Principal Investigator Email
- jacek.kieltucki@nowezdrowie-ck.pl
- Contact Person Name
- Jacek Kiełtucki
- Contact Person Email
- jacek.kieltucki@nowezdrowie-ck.pl
- Site Name
- H-T.Centrum Medyczne Sp. z o.o. sp.k.
- Department Name
- HT Centrum Medyczne - Endoterapia
- Principal Investigator Name
- Tomasz Romańczyk
- Principal Investigator Email
- romanczyk@htcentrum.pl
- Contact Person Name
- Tomasz Romańczyk
- Contact Person Email
- romanczyk@htcentrum.pl
Croatia
- Earliest CTIS Part Ii Submission Date
- 18-07-2025
- Latest Decision Or Authorization Date
- 08-05-2026
- Processing Time Days
- 294
- Number Of Sites
- 4
- Number Of Participants
- 4
Sites
- Site Name
- University Hospital Centre Zagreb
- Department Name
- Gastroenterology and Hepatology
- Principal Investigator Name
- Zeljko Krznaric
- Principal Investigator Email
- Zeljko.krznaric1@zg.t-com.hr
- Contact Person Name
- Zeljko Krznaric
- Contact Person Email
- Zeljko.krznaric1@zg.t-com.hr
- Site Name
- Specijalna Bolnica Medico
- Department Name
- Gastroenterology
- Principal Investigator Name
- Boris Brozovic
- Principal Investigator Email
- borisbrozovic@yahoo.com
- Contact Person Name
- Boris Brozovic
- Contact Person Email
- borisbrozovic@yahoo.com
- Site Name
- Poliklinika Solmed d.o.o.
- Department Name
- Gastroenterology
- Principal Investigator Name
- Dominik Kralj
- Principal Investigator Email
- dominik.rex@gmail.com
- Contact Person Name
- Dominik Kralj
- Contact Person Email
- dominik.rex@gmail.com
- Site Name
- Poliklinika Borzan d.o.o.
- Department Name
- Gastroenterology
- Principal Investigator Name
- Vladimir Borzan
- Principal Investigator Email
- vborzan@hotmail.com
- Contact Person Name
- Vladimir Borzan
- Contact Person Email
- vborzan@hotmail.com
Czechia
- Earliest CTIS Part Ii Submission Date
- 15-10-2025
- Latest Decision Or Authorization Date
- 04-05-2026
- Processing Time Days
- 201
- Number Of Sites
- 3
- Number Of Participants
- 6
Sites
- Site Name
- SurGal Clinic s.r.o.
- Department Name
- Oddělení chirurgie
- Principal Investigator Name
- Jan Ulbrych
- Principal Investigator Email
- ulbrych.jan@surgalclinic.cz
- Contact Person Name
- Jan Ulbrych
- Contact Person Email
- ulbrych.jan@surgalclinic.cz
- Site Name
- Vojenska Nemocnice Brno
- Department Name
- Interní oddělení
- Principal Investigator Name
- David Štěpek
- Principal Investigator Email
- dstepek@vnbrno.cz
- Contact Person Name
- David Štěpek
- Contact Person Email
- dstepek@vnbrno.cz
- Site Name
- Nemocnice Prachatice a.s.
- Department Name
- Gastroenterologická ambulance
- Principal Investigator Name
- Pavel Lipták
- Principal Investigator Email
- pavel.liptak@nempt.cz
- Contact Person Name
- Pavel Lipták
- Contact Person Email
- pavel.liptak@nempt.cz
Sponsor
Primary sponsor
- Full Name
- Mirador Therapeutics Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Psi Cro AG
- Responsibilities
- Sponsor duties codes: 1, 12 (as listed in CTIS third party entries)
Third parties
- {"country":"Switzerland","full_name":"Psi Cro AG","duties_or_roles":"[1,12]","organisation_type":"Pharmaceutical company"}
- {"country":"Canada","full_name":"Alimentiv Inc.","duties_or_roles":"[4]","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"[4]","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- MT-501
- Active Substance
- MT-501
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL USE
- Investigational Product Name
- MT-201
- Active Substance
- MT-201
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- PARENTERAL USE
- Route
- PARENTERAL USE
- Investigational Product Name
- Placebo for MT-501, film coated tablets
- Modality
- Other
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