NCT03980080

Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of OSE-127 in Healthy Subjects

Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study for the Assessment of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single and Multiple Ascending Intravenous and Subcutaneous Doses of OSE-127 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: OSE Immunotherapeutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study is a first-in-human phase I randomised, double-blind, placebo-controlled, evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single (IV and SC) and Multiple (IV only) Ascending Doses of OSE-127 in Healthy Subjects.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	OSE-127	mAb antagonist to CD127 receptor (or IL-7Rα) Group 1-7 6 escalating dose level groups IV SC
DRUG	Placebo	Vehicle study drug
DRUG	OSE-127	mAb antagonist to CD127 receptor (or IL-7Rα) Group 8-9 2 escalating dose level groups IV

Timeline

• Start date: 2018-12-19
• Primary completion: 2019-11-04
• Completion: 2019-11-04
• First posted: 2019-06-10
• Last updated: 2019-12-12

Locations

1 site across 1 country: Belgium