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NCT06158737Recruiting

A Clinical Trial Evaluated the Safety and Tolerability, Pharmacokinetic and Pharmacodynamics Profile, and Immunogenicity of a Single Dose of JS010 Injection in Healthy Subjects

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
Shanghai Junshi Bioscience Co., Ltd.Phase 1ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Migraine
Drug/Device/Intervention
JS010 injection
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Shanghai Junshi Bioscience Co., Ltd.
Location
Beijing, China
Timeline & enrollment
Phase
Phase 1
Start date
May 09, 2023
End date
Sep 21, 2024
Enrollment
48 participants
Primary outcome

Incidence of Treatment-Emergent Adverse Events

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.

ICD-10 classifications
MigraineOther migraineMigraine, unspecifiedComplicated migraineHeadache
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06158737
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06158737 through Pure Global AI's free database. This Phase 1 trial is sponsored by Shanghai Junshi Bioscience Co., Ltd. and is currently Recruiting. The study focuses on Migraine. Target enrollment is 48 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.