HealthyPhase 1NCT06637865

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

A Phase 1 study testing IMP761 and keyhole limpet haemocyanin (KLH) in people with Healthy, run by Immutep S.A.S. at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: IMP761 and keyhole limpet haemocyanin (KLH)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 79 participants
Where: 1 siteNetherlands
Study dates: 17 Jul 2024to 27 Aug 2026
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Signed informed consent and willing and able to comply with the study protocol;
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 following a detailed medical history, a complete physical examination including vital signs, laboratory measurements, and 12-lead electrocardiogram (ECG);
Female subjects agree to use effective contraception for the duration of their participation in the study and until 186 days after End of Study (EOS).
Male volunteers agree to use barrier protection when they engage in sexual relations with women of child-bearing potential (WOCBP) or lactating women for the duration of their participation in the study and until 96 days after EOS.
Body mass index (BMI) between 18 and 32 kg/m2, inclusive, and with a minimum bodyweight of 50 kg;
Fitzpatrick skin type I-III (cohorts 2-5 only);
Has the ability to communicate well with the Investigator in Dutch language and willing to comply with the study restrictions.
Has the intention to be reachable by mobile phone or e-mail during the whole study period.

Who cannot join

Evidence of any active or chronic disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the investigator (following a detailed medical history, physical examination, vital signs (systolic and diastolic blood pressure, pulse rate, body temperature) and 12-lead electrocardiogram (ECG)). Minor deviations from the normal range may be accepted, if judged by the Investigator to have no clinical relevance;
Clinically significant abnormalities, as judged by the Investigator, in laboratory test results (including haematology panel, chemistry panel and urinalysis). In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility. A rescreen will be allowed based on judgement of the investigator;
Positive immunodeficiency virus (HIV1, HIV2) antigen or antibody, Hepatitis B surface antigen (HBsAg), Hepatitis B Virus antibody (HBV Ab), Hepatitis C antibody (HCV Ab), (latent) Tuberculosis at screening;
Any disease associated with immune system impairment, including immune mediated diseases, transplantation patients and any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug or multiple drug allergies (non-active hay fever is acceptable);
Use of any medications (prescription or over-the-counter [OTC]), within 21 days prior to dosing with Investigational Medicinal Product (IMP), or less than 5 half-lives (whichever is longer). An exception is made for paracetamol (up to 4 g/day).
Use of vitamin, mineral, herbal and dietary supplements within 7 days prior to study drug administration, which are deemed clinically significant by the investigator.

Show all 14Show fewer

Use of immunosuppressive or immunomodulatory medication within 30 days prior to dosing with IMP or planned to use immunosuppressive or immunomodulatory medication during the course of the study.
Any vaccination within 30 days prior to dosing with IMP or planned during the course of the study or within 90 days after the last dose of IMP.
Use of antibiotic therapy within 90 days prior to dosing with IMP or planned to use during the course of the study.
Subject is unable to abstain from travelling to areas with high endemic rates of infectious diseases from study entry until 90 days after the last dose of IMP
Alcohol will not be allowed from at least 24 hours before screening and each scheduled visit. At other times during the course of the study no more than 2 units of alcohol per day will be allowed.
If a woman, pregnant, or breast-feeding, or planning to become pregnant during the study.
Have any current and/or recurrent clinically significant skin condition at the dermal challenge area (i.e. atopic dermatitis), including tattoos.
Any known factor, condition, or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

CHDR
Leiden, 2333

Other trials in Netherlands

About this study

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

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.

Read the 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
Being tested: IMP761, Placebo, keyhole limpet haemocyanin (KLH)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IMP761Drug
intravenous
PlaceboDrug
intravenous
keyhole limpet haemocyanin (KLH)Other
intramuscular immunization and intradermal challenge

Study groups in NCT06637865
Study group	Role	What they receive
Single ascending dose IMP761 Part A	Experimental	Randomized in 3:2 (IMP761:placebo) Cohort 1: 5 subjects Receives: Drug: IMP761
Single ascending dose Placebo Part A	Placebo comparator	Randomized in 3:2 (IMP761:placebo) Cohort 1: 5 subjects Receives: Drug: Placebo
Single ascending dose IMP761 Part B KLH challenge	Experimental	Randomized 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 Receives: Drug: IMP761; Other: keyhole limpet haemocyanin (KLH)
Single ascending dose Placebo Part B KLH challenge	Placebo comparator	Randomized 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 Receives: Drug: Placebo; Other: keyhole limpet haemocyanin (KLH)
Multiple ascending dose IMP761 Part C	Experimental	Randomized 5:2 (IMP761:placebo) every 28 days, 3 times. MAD Cohort 1: 7 subjects; MAD Cohort 2: 7 subjects Receives: Drug: IMP761
Multiple dose placebo Part C	Placebo comparator	Randomized 5:2 (IMP761:placebo) every 28 days, 3 times. MAD Cohort 1: 7 subjects; MAD Cohort 2: 7 subjects Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (10)

Pharmacokinetic (PK) parameter: Maximum Serum Concentration (Cmax) (Part B and C)
Measured: Up to 86 days
PK parameter: Timepoint of Maximum Serum Concentration (tmax) (Part B and C)
Measured: Up to 86 days
PK parameter: Minimum Serum concentration (Cmin) (Part B and C)
Measured: Up to 86 days
PK parameter: Area Under the Curve (AUC) (Part B and C)
Measured: Up to 86 days
PK parameter: systemic clearance (CL) (Part B and C)
Measured: Up to 86 days
PK parameter: Apparent volume of distribution at steady state (Vss) (Part B and C)
Measured: Up to 86 days
PK parameter: Apparent volume of distribution at terminal state (Vz) (Part B and C)
Measured: Up to 86 days
PK parameter: elimination half-life (t1/2) (Part B and C)
Measured: Up to 86 days
PK Parameter: Trough Concentration (Ctrough ) (Part C)
Measured: Up to 86 days
PK Parameter: Peak to trough ratio (PTR) (Part C)
Measured: Up to 86 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Jul 202427 Aug 2026

First posted15 Oct 2024
Study start17 Jul 2024
Primary completion27 Aug 2026
Study completion27 Aug 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Model description: There will be 10 cohorts in total: 8 single dose cohorts and 2 multiple dose cohorts
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 79 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06637865
Sponsor's protocol ID: IMP761-P001
Other IDs: 2024-510761-42-00
Status last verified: Sep 2026
First submitted: 9 Oct 2024
Last updated: 28 Sep 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Placebo-controlled, Double-blind Phase I Study in Healthy Volunteers With IMP761, a LAG-3 Agonist Antibody
ClinicalTrials.gov ID: NCT06637865
Acronym / sponsor ID: IMP761-P001
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 79 participants (actual)
Lead sponsor: Immutep S.A.S.Industry (pharma, biotech, devices)
Study start: 17 Jul 2024 (actual)
Primary completion: 27 Aug 2026 (actual)
Study completion: 27 Aug 2026 (actual)
First posted: 15 Oct 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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

Vital signs
Treatment-emergent (serious) adverse events ((S)AEs)
Electrocardiography.
Clinical laboratory tests
Laser speckle contrast imaging (LSCI)
Multispectral skin imaging

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 6
Model description: There will be 10 cohorts in total: 8 single dose cohorts and 2 multiple dose cohorts

Arm	Type	Receives
Single ascending dose IMP761 Part A	Experimental	Drug: IMP761Randomized in 3:2 (IMP761:placebo) Cohort 1: 5 subjects
Single ascending dose Placebo Part A	Placebo comparator	Drug: PlaceboRandomized in 3:2 (IMP761:placebo) Cohort 1: 5 subjects
Single ascending dose IMP761 Part B KLH challenge	Experimental	Drug: IMP761, Other: keyhole limpet haemocyanin (KLH)Randomized 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 challenge	Placebo comparator	Drug: Placebo, Other: keyhole limpet haemocyanin (KLH)Randomized 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 C	Experimental	Drug: IMP761Randomized 5:2 (IMP761:placebo) every 28 days, 3 times. MAD Cohort 1: 7 subjects; MAD Cohort 2: 7 subjects
Multiple dose placebo Part C	Placebo comparator	Drug: PlaceboRandomized 5:2 (IMP761:placebo) every 28 days, 3 times. MAD Cohort 1: 7 subjects; MAD Cohort 2: 7 subjects

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Signed informed consent and willing and able to comply with the study protocol;
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 following a detailed medical history, a complete physical examination including vital signs, laboratory measurements, and 12-lead electrocardiogram (ECG);
Female subjects agree to use effective contraception for the duration of their participation in the study and until 186 days after End of Study (EOS).
Male volunteers agree to use barrier protection when they engage in sexual relations with women of child-bearing potential (WOCBP) or lactating women for the duration of their participation in the study and until 96 days after EOS.
Body mass index (BMI) between 18 and 32 kg/m2, inclusive, and with a minimum bodyweight of 50 kg;

Key exclusion criteria (14 listed)

Evidence of any active or chronic disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the investigator (following a detailed medical history, physical examination, vital signs (systolic and diastolic blood pressure, pulse rate, body temperature) and 12-lead electrocardiogram (ECG)). Minor deviations from the normal range may be accepted, if judged by the Investigator to have no clinical relevance;
Clinically significant abnormalities, as judged by the Investigator, in laboratory test results (including haematology panel, chemistry panel and urinalysis). In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility. A rescreen will be allowed based on judgement of the investigator;
Positive immunodeficiency virus (HIV1, HIV2) antigen or antibody, Hepatitis B surface antigen (HBsAg), Hepatitis B Virus antibody (HBV Ab), Hepatitis C antibody (HCV Ab), (latent) Tuberculosis at screening;
Any disease associated with immune system impairment, including immune mediated diseases, transplantation patients and any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug or multiple drug allergies (non-active hay fever is acceptable);
Use of any medications (prescription or over-the-counter [OTC]), within 21 days prior to dosing with Investigational Medicinal Product (IMP), or less than 5 half-lives (whichever is longer). An exception is made for paracetamol (up to 4 g/day).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IMP761intravenous	Drug	Multiple ascending dose IMP761 Part C, Single ascending dose IMP761 Part A, Single ascending dose IMP761 Part B KLH challenge
Placebointravenous	Drug	Multiple dose placebo Part C, Single ascending dose Placebo Part A, Single ascending dose Placebo Part B KLH challenge
keyhole limpet haemocyanin (KLH)intramuscular immunization and intradermal challenge	Other	Single ascending dose IMP761 Part B KLH challenge, Single ascending dose Placebo Part B KLH challenge

Primary outcome

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

10 secondary outcomes

Pharmacokinetic (PK) parameter: Maximum Serum Concentration (Cmax) (Part B and C)
Time frame: Up to 86 days
PK parameter: Timepoint of Maximum Serum Concentration (tmax) (Part B and C)
Time frame: Up to 86 days
PK parameter: Minimum Serum concentration (Cmin) (Part B and C)
Time frame: Up to 86 days
PK parameter: Area Under the Curve (AUC) (Part B and C)
Time frame: Up to 86 days
PK parameter: systemic clearance (CL) (Part B and C)
Time frame: Up to 86 days
PK parameter: Apparent volume of distribution at steady state (Vss) (Part B and C)
Time frame: Up to 86 days
PK parameter: Apparent volume of distribution at terminal state (Vz) (Part B and C)
Time frame: Up to 86 days
PK parameter: elimination half-life (t1/2) (Part B and C)
Time frame: Up to 86 days
PK Parameter: Trough Concentration (Ctrough ) (Part C)
Time frame: Up to 86 days
PK Parameter: Peak to trough ratio (PTR) (Part C)
Time frame: Up to 86 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IMP761 and keyhole limpet haemocyanin (KLH) in people with Healthy, run by Immutep S.A.S. at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of clinically relevant abnormalities in vital signs (time frame: From screening to the follow up visit after last treatment (up to 143 days)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06637865.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.