Clinical trial • Phase II • Other
KM04 for Functional female infertility | Female infertility
Phase II trial of KM04 for Functional female infertility | Female infertility. US-Gonal-f RFF Redi-ject; EU-Gonal-f-controlled. 48 participants.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Functional female infertility | Female infertility
- Trial Stage
- Phase II
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 13-11-2025
- First CTIS Authorization Date
- 23-03-2026
Trial design
US-Gonal-f RFF Redi-ject; EU-Gonal-f-controlled Phase II trial in Poland.
- Comparator
- US-Gonal-f RFF Redi-ject; EU-Gonal-f
- Target Sample Size
- 48
Recruitment
- Planned Sample Size
- 48
- Recruitment Window Months
- 4
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 48
Poland
- Earliest CTIS Part Ii Submission Date
- 13-02-2026
- Latest Decision Or Authorization Date
- 23-03-2026
- Processing Time Days
- 38
- Number Of Sites
- 1
- Number Of Participants
- 48
Sites
- Site Name
- Biokinetica S.A.
- Department Name
- Przychodnia Jozefow
- Contact Person Name
- Monika Tomaszewska-Kiecana
- Contact Person Email
- monika.kiecana@biokinetica.com
Sponsor
Primary sponsor
- Full Name
- Xentria Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Investigational products
- Investigational Product Name
- KM04
- Modality
- Peptide/protein/enzyme
- Authorisation Status
- Investigational
- Investigational Product Name
- US-Gonal-f RFF Redi-ject
- Modality
- Peptide/protein/enzyme
- Authorisation Status
- Authorised (United States)
- Investigational Product Name
- EU-Gonal-f
- Modality
- Peptide/protein/enzyme
- Authorisation Status
- Authorised (European Union)
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