Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Gefurulimab PFS-SD · 1 trial · 1 indication
The AUClast exposure in healthy participants following a single SC dose of 600 mg gefurulimab by AI comparable to the PK exposure using the PFS-SD will be assessed.
The AUClinf exposure in healthy participants following a single SC dose of 600 mg gefurulimab by AI comparable to the PK exposure using the PFS-SD will be assessed.
The Cmax exposure in healthy participants following a single SC dose of 600 mg gefurulimab by AI comparable to the PK exposure using the PFS-SD will be assessed.
| Arm | Type | Description |
|---|---|---|
| Gefurulimab PFS-SD | EXPERIMENTAL | Participants will be administered gefurulimab as a single dose of 600 mg by PFS-SD on the abdomen, thigh, or upper arm. |
| Gefurulimab AI | EXPERIMENTAL | Participants will be administered gefurulimab as a single dose of 600 mg by AI on the abdomen, thigh, or upper arm. |
| Name | Type | Description |
|---|---|---|
| Gefurulimab PFS-SD | DRUG | Participants will receive a single 600 mg dose of Gefurulimab PFS-SD subcutaneously (SC) on Day 1. |
| Gefurulimab AI | DRUG | Participants will receive a single 600 mg dose of Gefurulimab AI subcutaneously (SC) on Day 1. |
Inclusion Criteria: 1. Participants must be 18 to 65 years of age inclusive, at the time of signing the informed consent. 2. Body weight within ≥ 50 to \< 110 kg and body mass index (BMI) within the range 18.5 to 30 kg/m2 (inclusive) 3. Participants who are healthy as determined by medical evaluati...
Gefurulimab PFS-SD is an investigational small molecule being studied in healthy adult participants. It is being evaluated in a Phase 1 clinical trial to assess the pharmacokinetics and safety of subcutaneous administration using a prefilled syringe compared to an autoinjector. The study is completed and enrolled 175 participants in Canada.
Gefurulimab PFS-SD is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker symbol AZN. The company is conducting clinical research on this investigational drug in healthy adult participants.
Gefurulimab PFS-SD is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. The Phase 1 trial has been completed, with results not yet reported.
Gefurulimab PFS-SD is associated with one completed Phase 1 clinical trial, identified by the National Clinical Trial number NCT06208488. The study, titled "A Study of Subcutaneous Gefurulimab Using Prefilled Syringe Versus Autoinjector in Healthy Adult Participants," enrolled 175 participants in Canada.
Gefurulimab PFS-SD is a specific formulation or presentation of the drug gefurulimab, designed for subcutaneous administration using a prefilled syringe. The clinical trial NCT06208488 compares this prefilled syringe version against an autoinjector device in healthy adult participants.