A Phase 1, First-In-Human, Dose-Escalation Clinical Study to Evaluate the Safety and Tolerability of Single and Multiple-Ascending Intravenous and Subcutaneous Doses of OSE-127 in Healthy Volunteers
Phase of Trial: Phase I
Latest Information Update: 20 Dec 2018
At a glance
- Drugs OSE 127 (Primary) ; OSE 127 (Primary)
- Indications Autoimmune disorders; Sjogren's syndrome; Ulcerative colitis
- Focus Adverse reactions; First in man
- 20 Dec 2018 Status changed from planning to recruiting, as reported in an OSE Immunotherapeutics media release.
- 20 Dec 2018 According to an OSE Immunotherapeutics media release, the first healthy volunteers have been dosed in the trial.
- 26 Nov 2018 According to an OSE Immunotherapeutics media release, the company has received authorization by Federal Agency for Medicines and Health Products (FAMH) and Belgian Ethics Committee to initiate this trial.