Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Dupilumab coformulated with berahyaluronidase alfa · 1 trial · 1 indication
Cmax: Maximum concentration observed in serum
AUClast: Area under the concentration in serum versus time curve calculated using the trapezoidal method from time zero to the real time tlast
| Arm | Type | Description |
|---|---|---|
| Treatment A | EXPERIMENTAL | Participants will receive a subcutaneous (SC) dose of dupilumab coformulated with berahyaluronidase alfa on Day 1 |
| Treatment B | EXPERIMENTAL | Participants will receive a SC dose of dupilumab without berahyaluronidase alfa on Day 1 |
| Name | Type | Description |
|---|---|---|
| Dupilumab coformulated with berahyaluronidase alfa | BIOLOGICAL | Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection |
| Dupilumab | BIOLOGICAL | Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection |
Inclusion Criteria: * Male and/or female participant, between 18 and 60 years of age, inclusive, at the time of signing the informed consent. * Determined to be healthy by the Investigator using a comprehensive clinical assessment (detailed medical history and complete physical examination). * Body...
Dupilumab coformulated with berahyaluronidase alfa is an investigational monoclonal antibody combination being studied in healthy volunteers. It is currently in Phase 1 clinical development to evaluate its pharmacokinetics and tolerability. The drug is not approved for any indication and remains under clinical investigation.
Sanofi (ticker: SNY) is developing Dupilumab coformulated with berahyaluronidase alfa. The company is conducting a Phase 1 clinical trial to assess the drug's pharmacokinetics and tolerability in healthy participants.
Dupilumab coformulated with berahyaluronidase alfa is in Phase 1 clinical development. It is an investigational drug being studied in healthy volunteers, and it has not been approved by regulatory authorities. The drug has received FDA priority review and orphan drug designations.
Dupilumab coformulated with berahyaluronidase alfa is being studied in one active Phase 1 trial, NCT07646548. This trial evaluates the pharmacokinetics and tolerability of subcutaneous dupilumab coformulated with berahyaluronidase alfa compared to dupilumab without berahyaluronidase alfa in healthy participants. The trial is enrolling 40 participants in the United States.
Dupilumab coformulated with berahyaluronidase alfa is a combination product that includes dupilumab plus berahyaluronidase alfa. It is being studied to compare its pharmacokinetics and tolerability against dupilumab without berahyaluronidase alfa in a Phase 1 clinical trial.