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

NCT03980080 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2019-12-12

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Servier

    collaborator INDUSTRY

  • OSE Immunotherapeutics

    lead INDUSTRY

Principal Investigators

  • Frédérique Corallo, MD · OSE Immunotherapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-19
Primary Completion
2019-11-04
Completion
2019-11-04

Countries

  • Belgium

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03980080 on ClinicalTrials.gov