NCT02800811View on ClinicalTrials.gov

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

PHASE1CompletedINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

April 30, 2015

Primary Completion Date

June 30, 2016

Study Completion Date

July 31, 2016

Conditions
Rheumatoid ArthritisComplication of Transplant
Interventions
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.

Trial Locations (1)

Unknown

SGS Antwerpen, Antwerp

Sponsors
All Listed Sponsors
lead

OSE Immunotherapeutics

INDUSTRY

NCT02800811 - Safety, Tolerability, PK, PD, and Immunogenicity of Single and Multiple Ascending Intravenous Doses of FR104 | Biotech Hunter | Biotech Hunter