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

NCT06158737 ↗

Phase 1 Completed 48 enrolled Shanghai Junshi Bioscience Co., Ltd.
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

EvaluationDrugModalityDoseRoute
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

Indications