Clinical trial • Phase I • Immunology

O3R-5671-PRO for Inflammatory bowel disease|Psoriasis

Phase I trial of O3R-5671-PRO for Inflammatory bowel disease|Psoriasis. 88 participants.

Overview

Trial Therapeutic Area
Immunology
Trial Disease
Inflammatory bowel disease|Psoriasis
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
01-07-2025
First CTIS Authorization Date
13-08-2025

Trial design

Phase I trial across 1 site in Belgium.

Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
88

Eligibility

Recruits 88 No vulnerable population selected; trial enrolls healthy adult male volunteers only; consent/assent process not specified in available documents..

Vulnerable Population
No vulnerable population selected; trial enrolls healthy adult male volunteers only; consent/assent process not specified in available documents.

Recruitment

Planned Sample Size
88
Recruitment Window Months
10

Geography

Total Number Of Sites
1
Total Number Of Participants
88

Belgium

Earliest CTIS Part Ii Submission Date
22-07-2025
Latest Decision Or Authorization Date
24-02-2026
Processing Time Days
217
Number Of Sites
1
Number Of Participants
88

Sites

Site Name
SGS Belgium
Department Name
SGS-Clinical Research CPU
Contact Person Name
Lotte Verwilligen
Contact Person Email
Lotte.Verwilligen@sgs.com

Sponsor

Primary sponsor

Full Name
Coultreon Biopharma
Organisation Type
Pharmaceutical company
Country Of Registered Address
Belgium

Contract research organisations

Name
SGS Belgium
Responsibilities
Site conduct / SGS-Clinical Research CPU (listed as department); contact person Lotte Verwilligen (Lotte.Verwilligen@sgs.com) as provided in trial site record.

Investigational products

Investigational Product Name
O3R-5671-PRO

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