NCT06537050

A Randomized, Double-blind, Placebo-controlled Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of JX2105 in Healthy Chinese Subjects

A Randomized, Double-blind, Placebo-controlled Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of JX2105 in Healthy Chinese Subjects The Purpose of the Study is to Evaluate the Safety, Tolerability After Administration of Single Dose or Multiple Doses, and the Pharmacokinetics (PK) of Single and Multiple Doses of JX2105 in Healthy Study Participants.

• Status: Enrolling By Invitation
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Zhejiang Jingxin Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to evaluate the safety, tolerability after administration of single dose or multiple doses, and the pharmacokinetics (PK) of single and multiple doses of JX2105 in healthy study participants.

Detailed description

Overall design: This study is divided into 3 parts: Part 1: single-dose escalation study (SAD); Part 2: multiple-dose escalation study (MAD); Part 3: food-effect study (FE). Part 1 includes 7 cohorts; Part 2 includes 2\~3cohorts; and Part 3 food effect study will conduct on 1 dose strength to evaluate the effect of food intake on pharmacokinetic/pharmacodynamics of JX2105 and its metabolites. The doses of part 2 and 3 will be designed according to the PK parameters from Part 1. Maximum recommended human dose of part 1 is 10 mg and the maximum dose is 180 mg.

Conditions

• Parkinson's Disease

Interventions

Type	Name	Description
DRUG	JX2105	Oral capsule
DRUG	Placebo	Oral capsule

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-01-30
• Completion: 2025-03-01
• First posted: 2024-08-05
• Last updated: 2024-08-05

Locations

1 site across 1 country: China