drugset / Trial / NCT06158737
A Clinical Trial Evaluated the Safety and Tolerability, Pharmacokinetic and Pharmacodynamics Profile, and Immunogenicity of a Single Dose of JS010 Injection in Healthy Subjects
RandomizedSequentialTriple-blindTreatment
Summary
This study adopts a dose escalation design with six preset dose levels, namely 3mg, 30mg, 150mg, 300mg,600mg, 900mg, single subcutaneous injection. A total of 48 healthy subjects will be enrolled in the experiment, 8 in each group.They will be randomly assigned to receive JS010 injection and matching placebo in a ratio of 3:1. In accordance with the dose-escalation principle,Starting from the lowest initial dose, increasing to the higher dose and proceeding in sequence. Each subject can receive only one dose Level of single subcutaneous administration.
Timeline
- Start
- 2023-05-10
- Primary completion
- 2024-06-23
- Completion
- 2024-06-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | JS010 | Unknown | 3 mg | Subcutaneous |
| Subject | JS010 | Unknown | 30 mg | Subcutaneous |
| Subject | JS010 | Unknown | 150 mg | Subcutaneous |
| Subject | JS010 | Unknown | 300 mg | Subcutaneous |
| Subject | JS010 | Unknown | 600 mg | Subcutaneous |
| Subject | JS010 | Unknown | 900 mg | Subcutaneous |