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IMP761

Phase 1

Healthy | Small molecule | Other |Immutep Limited|Last Updated: Apr 23, 2026

Target and mechanism

Molecular targetLAG-3
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment79

FDA Designations

No designations recorded

Clinical trial landscape

IMP761 · 1 trial · 1 indication

Phase 1 1
NCT06637865A First-in-human Study of the Safety of an Immunosuppressive Antibody (IMP761) in Healthy VolunteersHealthy
RECRUITING79 Analytics
PHASE1RECRUITING
A First-in-human Study of the Safety of an Immunosuppressive Antibody (IMP761) in Healthy Volunteers
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Occurrence of clinically relevant abnormalities in vital signs
From screening to the follow up visit after last treatment (up to 143 days)
Frequency of adverse events (AEs)
From administration to the follow up visit after last treatment (up to 103 days)
Duration of adverse events (AEs)
From administration to the follow up visit after last treatment (up to 103 days)
Severity of adverse events (AEs)
From administration to the follow up visit after last treatment (up to 103 days)
Occurrence of clinically relevant abnormalities in electrocardiography
From screening to the follow up visit after last treatment (up to 143 days)
Occurrence of clinically relevant abnormalities in safety laboratory assessments
From screening to the follow up visit after last treatment (up to 143 days)

Secondary Endpoints

Pharmacokinetic (PK) parameter: Maximum Serum Concentration (Cmax) (Part B and C)
Up to 86 days
PK parameter: Timepoint of Maximum Serum Concentration (tmax) (Part B and C)
Up to 86 days
PK parameter: Minimum Serum concentration (Cmin) (Part B and C)
Up to 86 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Single ascending dose IMP761 Part AEXPERIMENTALRandomized in 3:2 (IMP761:placebo) Cohort 1: 5 subjects
Single ascending dose Placebo Part APLACEBO_COMPARATORRandomized in 3:2 (IMP761:placebo) Cohort 1: 5 subjects
Single ascending dose IMP761 Part B KLH challengeEXPERIMENTALRandomized in 4:1 (IMP761:placebo). KLH immunization followed by IMP761 on Day 1 and dermal rechallenge on day 2 (Cohorts 2-3) or on days 2, 9 and 23 (Cohorts 4-8) Cohort 2: 5 subjects; Cohort 3: 5 subjects; Cohort 4: 10 subjects; Cohort 5: 10 subjects; Cohort 6: 10 subjects; Cohort 7: 10 subjects; Cohort 8: 10 subjects
Single ascending dose Placebo Part B KLH challengePLACEBO_COMPARATORRandomized in 4:1 (IMP761:placebo). KLH immunization followed by placebo on Day 1 and dermal rechallenge on day 2 (Cohorts 2-3) or on days 2, 9 and 23 (Cohorts 4-8) Cohort 2: 5 subjects; Cohort 3: 5 subjects; Cohort 4: 10 subjects; Cohort 5: 10 subjects; Cohort 6: 10 subjects; Cohort 7: 10 subjects; Cohort 8: 10 subjects
Multiple ascending dose IMP761 Part CEXPERIMENTALRandomized 5:2 (IMP761:placebo) every 28 days, 3 times. MAD Cohort 1: 7 subjects; MAD Cohort 2: 7 subjects
Multiple dose placebo Part CPLACEBO_COMPARATORRandomized 5:2 (IMP761:placebo) every 28 days, 3 times. MAD Cohort 1: 7 subjects; MAD Cohort 2: 7 subjects

Interventions

NameTypeDescription
IMP761DRUGintravenous
PlaceboDRUGintravenous
keyhole limpet haemocyanin (KLH)OTHERintramuscular immunization and intradermal challenge
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Signed informed consent and willing and able to comply with the study protocol; 2. Healthy men or women, 18 to 55 years of age (inclusive) at screening. The health status is verified by absence of evidence of any clinically significant active or uncontrolled chronic disease f...

Countries:Netherlands
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Frequently asked questions about IMP761

What is IMP761 used for?

IMP761 is an investigational immunosuppressive antibody being studied in healthy volunteers. It is currently in a Phase 1 first-in-human clinical trial to evaluate its safety. The drug is being developed by Immutep Limited as a small molecule, though it is described as an antibody in the trial title.

What does IMP761 target?

IMP761 targets LAG-3, a protein involved in immune regulation. By targeting LAG-3, the drug is designed to have an immunosuppressive effect, which may have potential applications in autoimmune diseases or other conditions where dampening the immune response is desirable. However, its specific therapeutic indications are still under investigation.

Who makes IMP761?

IMP761 is being developed by Immutep Limited, a biopharmaceutical company listed on the stock exchange under the ticker IMMP. The company is conducting a Phase 1 clinical trial to assess the safety of this investigational drug in healthy volunteers.

What phase is IMP761 in?

IMP761 is in Phase 1 clinical development. It is currently being evaluated in a first-in-human study that is recruiting participants. The drug is investigational and has not been approved by regulatory authorities. The trial is designed to assess its safety in healthy volunteers.

What clinical trials is IMP761 in?

IMP761 is being studied in one active clinical trial, NCT06637865, titled 'A First-in-human Study of the Safety of an Immunosuppressive Antibody (IMP761) in Healthy Volunteers.' This Phase 1 trial is recruiting 79 participants in the Netherlands and is randomized, double-blind, and placebo-controlled.

Is IMP761 the same as an immunosuppressive antibody?

Yes, IMP761 is described as an immunosuppressive antibody in its clinical trial title. It is being developed to suppress the immune system by targeting LAG-3. The drug is currently in Phase 1 testing to evaluate its safety in healthy volunteers, and its mechanism involves modulating immune responses.