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Also known as ALXN1720
Gefurulimab PFS-SD · 3 trials · 3 indications
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 |
|---|---|---|
| ALXN1720 | EXPERIMENTAL | Participants will receive a weight-based initial (loading) dose of ALXN1720 on Day 1, followed by weight-based maintenance treatment with ALXN1720 on Day 8 and once every week (Q1W) thereafter for a total of 26 weeks. Following this randomized controlled treatment (RCT) period, all participants will receive ALXN1720 in an open-label extension (OLE) period of 105 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo during the 26-week RCT period, after which they will enter the OLE period of the study and receive ALXN1720. |
| 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 |
|---|---|---|
| ALXN1720 | COMBINATION_PRODUCT | Combination product consisting of syringe prefilled with ALXN1720. |
| Placebo | COMBINATION_PRODUCT | Combination product consisting of syringe prefilled with placebo. |
| 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: * Diagnosis of MG with generalized muscle weakness meeting the clinical criteria defined by Myasthenia Gravis Foundation of America (MGFA) Class II, III or IV * Positive serological test for autoantibodies against AChR Exclusion Criteria: * History of thymectomy, or any other ...
Gefurulimab PFS-SD is an investigational monoclonal antibody being developed by AstraZeneca PLC. The PFS-SD designation refers to a prefilled syringe presentation of gefurulimab. It is in Phase 1 clinical development, and its therapeutic indications have not been disclosed.
Gefurulimab PFS-SD is being developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor of the clinical program evaluating this monoclonal antibody candidate.
Gefurulimab PFS-SD is in Phase 1 clinical development. It is an investigational agent and is not approved for any indication. One Phase 1 trial has been completed, and no trials are currently active.
Gefurulimab PFS-SD has been evaluated in one completed Phase 1 trial, NCT06208488, titled A Study of Subcutaneous Gefurulimab Using Prefilled Syringe Versus Autoinjector in Healthy Adult Participants. The trial enrolled 175 healthy adult participants in Canada and used a randomized, controlled design.
Gefurulimab PFS-SD is an investigational monoclonal antibody in Phase 1 development, and its target indications have not been disclosed. The completed Phase 1 trial, NCT06208488, was conducted in healthy adult volunteers rather than in patients with a specific disease.
Gefurulimab PFS-SD is being studied as a subcutaneous administration using a prefilled syringe. The completed Phase 1 trial, NCT06208488, compared the prefilled syringe presentation against an autoinjector in 175 healthy adult participants in Canada.