Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IMP761 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Single ascending dose IMP761 Part A | EXPERIMENTAL | Randomized in 3:2 (IMP761:placebo) Cohort 1: 5 subjects |
| Single ascending dose Placebo Part A | PLACEBO_COMPARATOR | Randomized in 3:2 (IMP761:placebo) Cohort 1: 5 subjects |
| 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 |
| 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 |
| 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 |
| 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 |
| Name | Type | Description |
|---|---|---|
| IMP761 | DRUG | intravenous |
| Placebo | DRUG | intravenous |
| keyhole limpet haemocyanin (KLH) | OTHER | intramuscular immunization and intradermal challenge |
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...
IMP761 is an investigational small molecule developed by Immutep Limited as an immunosuppressive agent. It is designed to target LAG-3, a protein involved in immune regulation. The drug has completed a Phase 1 first-in-human study in healthy volunteers, and its specific clinical indications have not been disclosed.
IMP761 targets LAG-3, a protein receptor that plays a role in modulating immune responses. By binding to LAG-3, IMP761 is intended to suppress immune activity. This mechanism is being explored for potential therapeutic applications, though the exact indications remain undisclosed.
IMP761 is being developed by Immutep Limited, an Australian biotechnology company listed on the NASDAQ under the ticker symbol IMMP. Immutep focuses on developing immunotherapies, and IMP761 is part of its pipeline as an immunosuppressive candidate.
IMP761 is in Phase 1 clinical development. A first-in-human study has been completed, and the drug remains investigational. It has not been approved by the FDA or any regulatory agency for any indication.
IMP761 has been evaluated in a Phase 1 clinical trial, NCT06637865, titled 'A First-in-human Study of the Safety of an Immunosuppressive Antibody (IMP761) in Healthy Volunteers.' This completed trial enrolled 79 healthy participants in the Netherlands and was randomized, double-blind, and placebo-controlled.