NCT06549309

Trial of JMKX003801 in Healthy Participants

A Phase I, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics of JMKX003801 in Healthy Participants

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Jemincare · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To Evaluate the Safety, Tolerability, and Pharmacokinetic Characteristics of JMKX003801 Administered Randomly, Double-blind, Placebo-controlled, Single-ascending Dose and Multiple-ascending Dose in Chinese Healthy Adult Participants

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	JMKX003801	For Ascending Single Dose of JMKX003801，Five（5）cohorts of 40 participants (each cohort contains 6 active and 2 placebo) are planned for evaluation. For Ascending Multiple Dose of JMKX003801，Three（3）cohort of 30 participants (each cohort contains 8 active and 2 placebo) are planned for evaluation.
DRUG	Placebo	For Ascending Single Dose of JMKX003801，Five（5）cohorts of 40 participants (each cohort contains 6 active and 2 placebo) are planned for evaluation. For Ascending Multiple Dose of JMKX003801，Three（3）cohorts of 30 participants (each cohort contains 8 active and 2 placebo) are planned for evaluation.

Timeline

• Start date: 2024-08-17
• Primary completion: 2025-05-31
• Completion: 2025-06-12
• First posted: 2024-08-12
• Last updated: 2024-09-26

Locations

1 site across 1 country: China