Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Clinical Trial Evaluated the Safety and Tolerability, Pharmacokinetic and Pharmacodynamics Profile, and Immunogenicity of a Single Dose of JS010 Injection in Healthy Subjects
Sponsor: Shanghai Junshi Bioscience Co., Ltd.
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.
Official title: A Randomized, Double-blind, Placebo-controlled Clinical Trial Evaluated the Safety and Tolerability, Pharmacokinetic and Pharmacodynamics Profile, and Immunogenicity of a Single Dose of JS010 Injection in Healthy Subjects
Key Details
Gender
All
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
48
Start Date
2023-05-10
Completion Date
2024-06-23
Last Updated
2026-07-17
Healthy Volunteers
Yes
Conditions
Interventions
JS010 injection
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 were enrolled in the experiment, 8 in each group.They were 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.
Placebo
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 were enrolled in the experiment, 8 in each group.They were 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.
Locations (1)
Peking University Third Hospital
Beijing, Beijing Municipality, China