NCT06637865

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 79 (estimated)
• Sponsor: Immutep S.A.S. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a first in human, randomized, prospective, single centre, double blind, placebo-controlled study in healthy volunteers. It consists of three separate parts (Part A, B and C) with different study designs. The main objective is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending dose (SAD) (Part A and B) and multiple ascending doses (MAD) (Part C) of IMP761 as assessed by: * Vital signs * Treatment-emergent (serious) adverse events ((S)AEs) * Electrocardiography. * Clinical laboratory tests * Laser speckle contrast imaging (LSCI) * Multispectral skin imaging Part A: SAD study in healthy subjects (cohort 1, 5 subjects) Cohort 1: 5 subjects, single i.v. dose of IMP761 or placebo (3:2). The first 2 subjects will receive IMP761 or placebo (1:1) as sentinel dosing, while the following 3 subjects will receive IMP761 or placebo (2:1). Part B: SAD study in healthy subjects, KLH challenge (cohort 2-8, 60 subjects) Cohort 2-3: 5 subjects, single i.v. dose of IMP761or placebo (4:1). Cohort 4-8: 10 subjects, single i.v. dose of IMP761 or placebo (8:2). Part C: MAD study in healthy subjects (MAD cohort 1-2, 14 subjects) MAD Cohort 1-2: 7 subjects, multiple (three i.v. doses of IMP761 or placebo (5:2). Investigational Medicinal Product (IMP)/placebo administration every 28 days; dose selection to be based on observed pharmacodynamic effects in part B.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	IMP761	intravenous
DRUG	Placebo	intravenous
OTHER	keyhole limpet haemocyanin (KLH)	intramuscular immunization and intradermal challenge

Timeline

• Start date: 2024-07-17
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2024-10-15
• Last updated: 2025-07-24

Locations

1 site across 1 country: Netherlands