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RECRUITING
NCT06637865
PHASE1

A First-in-human Study of the Safety of an Immunosuppressive Antibody (IMP761) in Healthy Volunteers

Sponsor: Immutep S.A.S.

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to evaluate the safety and tolerability of single and multiple doses of IMP761 in healthy female and male volunteers aged 18-55 with no history of disease affecting the immune system or recent use of medication with effects on the immune system. The main question it aims to answer is: \- if IMP761 is safe and tolerable as determined by assessing vital signs, emerging (serious) adverse events, electrocardiography, and clinical laboratory tests. Researchers will compare IMP761 to a placebo (a look-alike substance that contains no drug) to see if single and multiple doses of IMP761 are safe and tolerable in healthy volunteers. Part B of the study also investigates the effect of IMP761 on the inhibition of the keyhole limpet haemocyanin (KLH) driven immune response compared with placebo. Participants will: * receive IMP761 or a matching placebo intravenously once in single dose (part A and B) and three times in multiple dose (part C) during a 4 day in clinic stay with 4-8 following visits. * receive KLH challenge * be monitored for up to 103 days after the first dose.

Official title: A Placebo-controlled, Double-blind Phase I Study in Healthy Volunteers With IMP761, a LAG-3 Agonist Antibody

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

79

Start Date

2024-07-17

Completion Date

2026-04

Last Updated

2025-07-24

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

IMP761

intravenous

DRUG

Placebo

intravenous

OTHER

keyhole limpet haemocyanin (KLH)

intramuscular immunization and intradermal challenge

Locations (1)

CHDR

Leiden, Netherlands