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 monoclonal antibody developed by Sanofi. It is a drug product formulation of amlitelimab studied in a Phase 1 pharmacokinetic comparability trial in healthy participants. The trial compared two different amlitelimab drug products and enrolled 32 healthy volunteers in the United States.
Amlitelimab DP1 targets TNFSF4, also known as OX40 ligand. It is an inhibitor of this target. By binding TNFSF4, the antibody is designed to interfere with TNFSF4-mediated signaling. TNFSF4 is a member of the tumor necrosis factor superfamily and is involved in immune cell costimulation.
Amlitelimab DP1 is developed by Sanofi, which trades under the ticker SNY. Sanofi is the sponsor of the clinical program for this monoclonal antibody drug product.
Amlitelimab DP1 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The Phase 1 program consists of one completed trial, a pharmacokinetic comparability study of two different amlitelimab drug products in healthy participants.
Amlitelimab DP1 has been studied in one clinical trial, NCT05796479, titled A PK Comparability Study of Two Different Amlitelimab Drug Products in Healthy Participants. This Phase 1 trial was completed, enrolled 32 healthy volunteers, and was conducted in the United States.
Amlitelimab DP1 is a drug product formulation of amlitelimab, the monoclonal antibody developed by Sanofi that targets TNFSF4. The DP1 designation refers to a specific drug product evaluated in a Phase 1 pharmacokinetic comparability study against another amlitelimab drug product.