Clinical trial • Phase I • Immunology
LCA-0321 for Graves' disease
Phase I trial of LCA-0321 for Graves' disease. adaptive. 48 participants.
Overview
- Trial Therapeutic Area
- Immunology
- Trial Disease
- Graves' disease
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 17-12-2025
- First CTIS Authorization Date
- 06-03-2026
Trial design
adaptive Phase I trial across 3 sites in Netherlands.
- Adaptive
- True - dose escalation design: single ascending dose (SAD) and multiple ascending dose (MAD) cohorts; specific escalation rules not provided
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 48
Eligibility
Recruits 48 Vulnerable populations not selected; no consent/assent details provided..
- Vulnerable Population
- Vulnerable populations not selected; no consent/assent details provided.
Recruitment
- Planned Sample Size
- 48
- Recruitment Window Months
- 29
Geography
- Total Number Of Sites
- 3
- Total Number Of Participants
- 48
Netherlands
- Earliest CTIS Part Ii Submission Date
- 27-02-2026
- Latest Decision Or Authorization Date
- 17-03-2026
- Processing Time Days
- 18
- Number Of Sites
- 3
- Number Of Participants
- 48
Sites
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Endocrinology
- Principal Investigator Name
- Marco Medici
- Principal Investigator Email
- m.medici@erasmusmc.nl
- Contact Person Name
- Marco Medici
- Contact Person Email
- m.medici@erasmusmc.nl
- Site Name
- Brain Research Center Den Bosch B.V.
- Department Name
- Internal medicine/ endocrinology
- Principal Investigator Name
- Marieke de Vries
- Principal Investigator Email
- mar.d.vries@jbz.nl
- Contact Person Name
- Marieke de Vries
- Contact Person Email
- mar.d.vries@jbz.nl
- Site Name
- CTC Netherlands B.V.
- Department Name
- CTC
- Principal Investigator Name
- Khalid Sayed Abd-Elaziz
- Principal Investigator Email
- khalid.abdelaziz@ctc-netherlands.com
- Contact Person Name
- Khalid Sayed Abd-Elaziz
- Contact Person Email
- khalid.abdelaziz@ctc-netherlands.com
Sponsor
Primary sponsor
- Full Name
- Lycia Therapeutics Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- LCA-0321
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