Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06208488 | A Study of Subcutaneous Gefurulimab Using Prefilled Syringe Versus Autoinjector in Healthy Adult Participants | PHASE1 | COMPLETED | 175 | — | — | Nov 22, 2023 | Sep 28, 2024 | Oct 23, 2024 | 2 | Canada |
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...