drugset / Trial / NCT07206043
Pharmacokinetics, Safety and Immunogenicity of RPH-104 at a New Dosage and Different Doses Via Single Subcutaneous and Intravenous Administration in Healthy Volunteers
Phase 1
Completed
130 enrolled
R-Pharm International, LLC
Exacte Labs LLC · collabJSC "R-Pharm", Russia (R-Pharm Group) · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
The purpose of this study is to evaluate the safety, immunogenicity and pharmacokinetics of RPH-104 after single intravenous and subcutaneous administration to healthy volunteers at different doses
Timeline
- Start
- 2024-12-03
- Primary completion
- 2025-02-27
- Completion
- 2025-07-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Goflikicept | Monoclonal antibody | 80 mg | Intravenous |
| Subject | Goflikicept | Monoclonal antibody | 160 mg | Intravenous |
| Subject | Goflikicept | Monoclonal antibody | 320 mg | Intravenous |
Indications
No indication recorded.