NCT07240675

Single-dose,First-in-human of KLA478

A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Doses of KLA478 in Healthy Volunteers

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Hunan Kelun Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and tolerability and pharmacokinetics of single doses of KLA478 in healthy volunteers；

Detailed description

This study is a single-center, randomized/non-randomized, single ascending dose（SAD）, Phase I clinical trial conducted in healthy subjects, divided into two parts: Part 1 is an open-label single-dose study of active comparator to evaluate the pharmacokinetic characteristics of active comparator in healthy subjects； Part 2 is a randomized, double-blind, placebo-controlled single ascending dose study of KLA478: The purpose of this study is to evaluate the safety and tolerability and pharmacokinetics of single doses of KLA478 in healthy volunteers；

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	pramipexole hydrochloride sustained-release tablets	P.O., single dose
DRUG	KLA478	intramuscular injection, single dose
DRUG	placebo	intramuscular injection, single dose

Timeline

• Start date: 2025-11-26
• Primary completion: 2026-09-30
• Completion: 2026-09-30
• First posted: 2025-11-21
• Last updated: 2026-02-27

Locations

1 site across 1 country: China