NCT02800811

Safety, Tolerability, PK, PD, and Immunogenicity of Single and Multiple Ascending Intravenous Doses of FR104

Randomized, Double-blind, Placebo-controlled, Dose-escalation Study for the Assessment of Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single and Multiple Intravenous Doses of FR104 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: OSE Immunotherapeutics · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

First-in-human, phase I, randomized, double-blind, placebo-controlled, single center study evaluating single and multiple ascending intravenous doses of FR104 in healthy subjects.

Detailed description

This study is a first-in-human, phase I, randomized, double-blind, placebo-controlled, single center study evaluating single and multiple ascending intravenous doses of FR104 in healthy subjects. 64 healthy male and female subjects are selected according to the inclusion and exclusion criteria, i.e., 50 subjects in Part 1 (SAD: 2 cohorts of 22 \[Cohort A\], 28 \[Cohort B\], respectively) and 14 subjects in Part 2 (MAD). The total duration of the study is 10 months. All FR104 doses are administered intravenously by a slow infusion of at least 30 minutes. A staggered approach is observed within all dose levels. An interval of at least 14 days (last to first administration) is observed between all dose levels. Individual subjects on a same day of dosing are dosed at least 60 minutes apart.

Conditions

• Rheumatoid Arthritis
• Complication of Transplant

Interventions

Type	Name	Description
DRUG	FR104	GMP FR104 is provided to the site in extractable volume vials containing FR104. Appropriate Dilutions in Ringer's lactate solution is made on site.
DRUG	Placebo	The placebo injection contains the vehicle. For placebo dosing, vehicle is administered in accordance with the volume of study drug administered.

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-06-01
• Completion: 2016-07-01
• First posted: 2016-06-15
• Last updated: 2016-07-21

Locations

1 site across 1 country: Belgium