Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Amlitelimab DP1 · 1 trial · 1 indication
Cmax after administration of a single SC dose of amlitelimab DP 1
AUClast after administration of a single SC dose of amlitelimab DP 1
AUC after administration of a single SC dose of amlitelimab DP 1
Cmax after administration of a single SC dose of amlitelimab DP 1 and DP2
AUClast after administration of a single SC dose of amlitelimab DP1 and DP 2
AUC after administration of a single SC dose of amlitelimab DP1 and DP 2
| Arm | Type | Description |
|---|---|---|
| Group 1 (Part1) | EXPERIMENTAL | Participants will receive a single SC dose of amlitelimab DP1 on Day 1. |
| Group 2 (Part 2) | EXPERIMENTAL | Participants will receive a single SC dose of amlitelimab DP1 on Day 1. |
| Group 3 (Part 2) | EXPERIMENTAL | Participants will receive a single SC dose of amlitelimab DP2 on Day 1. |
| Name | Type | Description |
|---|---|---|
| Amlitelimab DP1 | DRUG | Injection solution 1 Subcutaneous |
| Amlitelimab DP2 | DRUG | Injection solution 2 Subcutaneous |
Inclusion Criteria: * Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent. * Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, ECG, and laboratory tests * Body weight within 55 to 10...
Amlitelimab DP1 is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed trial that enrolled 32 participants in the United States to assess the drug product.
Amlitelimab DP1 is being developed by Sanofi, a biopharmaceutical company listed on the stock exchange under the ticker SNY. The company is conducting clinical research on this investigational small molecule.
Amlitelimab DP1 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and pharmacokinetics in healthy volunteers.
Amlitelimab DP1 has one completed clinical trial, identified as NCT05796479. This Phase 1 study, titled 'A PK Comparability Study of Two Different Amlitelimab Drug Products in Healthy Participants,' enrolled 32 healthy volunteers in the United States and was a controlled, randomized study.
Amlitelimab DP1 is a specific drug product formulation of Amlitelimab. The clinical trial NCT05796479 was designed to compare the pharmacokinetics of two different Amlitelimab drug products, with Amlitelimab DP1 being one of them.