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Genz-682452 · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Genz-682452 | EXPERIMENTAL | This study will include three cohorts for doses of Genz-682452: Dose 1, Dose 2, Dose 3. Each cohort will include 12 participants, 9 of whom will be administered Genz-682452 and 3 will be administered placebo. |
| Placebo | PLACEBO_COMPARATOR | Placebo comparator taken by participants randomized to the placebo arm in each of the three cohorts. Each cohort will include 12 participants, 9 of whom will be administered Genz-682452 and 3 will be administered placebo. |
| Part 1 (GZFD00111/TDU12766): Genz-682452 | EXPERIMENTAL | Participants will receive a single oral dose of Genz-682452. Six ascending single doses and an optional seventh dose under fasted conditions will be used. |
| Part 1 (GZFD00111/TDU12766): Placebo | PLACEBO_COMPARATOR | Participants will receive a single oral dose of placebo. |
| Part 2 (GZFD00211/FED12767): Genz-682452 | EXPERIMENTAL | Participants will receive two single doses of Genz-682452 separated by a 7-day wash-out period, one dose given under fed (standardized high-fat breakfast) and one under fasted conditions. The dose will be based on the blind review of the safety/tolerability/pharmacokinetic data of single dose level cohorts in Part 1. |
| Name | Type | Description |
|---|---|---|
| Genz-682452 | BIOLOGICAL | Capsules for oral administration. |
| Placebo | BIOLOGICAL | Placebo capsules matching the Genz-682452 capsules. |
Inclusion Criteria: * Body weight between 50.0 and 95.0 kg, inclusive, if male and between 40.0 and 85.0 kg inclusive, if female, body mass index between 18.0 and 30.0 kg/m\^2, inclusive. * Certified as healthy by a comprehensive clinical assessment. Exclusion Criteria: * Any history or presence ...
Genz-682452 is an investigational monoclonal antibody being studied in healthy volunteers. It is in Phase 1 clinical development, with trials evaluating its safety, tolerability, and pharmacokinetics in healthy men and healthy volunteers. It is not approved for any disease and remains in early-stage clinical testing.
Genz-682452 is being developed by Sanofi, a biopharmaceutical company listed on the stock exchange under the ticker SNY. The drug is currently in Phase 1 clinical development, with completed trials in healthy volunteers.
Genz-682452 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. Clinical trials have been completed in healthy volunteers to assess safety, tolerability, and pharmacokinetics.
Genz-682452 has been studied in two completed Phase 1 clinical trials. NCT01674036 evaluated safety, tolerability, and pharmacokinetics in healthy men, enrolling 63 participants. NCT01710826 assessed safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers, enrolling 36 participants. Both trials were conducted in the United States.
Yes, Genz-682452 is a monoclonal antibody. It is being developed as an investigational therapy and is currently in Phase 1 clinical trials involving healthy volunteers. Its mechanism of action has not been publicly detailed in the available trial information.