NCT06867393

Safety, Tolerability, and Pharmacokinetics of HL-003 in Healthy Subjects

Phase I Clinical Study of the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Oral Doses of HL-003 in Healthy Subjects

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Shanghai Kechow Pharma, Inc. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This clinical study aims to evaluate the safety, tolerability, and pharmacokinetic characteristics of HL-003 tablets in healthy subjects. It is conducted in two sequential clinical phases: single-dose and multiple-dose escalation.

Detailed description

The single-dose escalation clinical trial of HL-003 tablets is designed as a dose-escalation, randomized, double-blind, placebo-controlled, parallel-group study. The multiple-dose clinical trial of HL-003 tablets is designed as a randomized, double-blind, placebo-controlled, parallel-group study. The specific dosage, dosing frequency, and duration of continuous administration will be adjusted based on the results of the single-dose escalation clinical study.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	HL-003 tablet Placeco	100mg、250mg、500mg、1000mg、1500mg，SAD
DRUG	HL-003 tablet	25mg、100mg、250mg、500mg、1000mg、1500mg，SAD

Timeline

• Start date: 2025-02-28
• Primary completion: 2025-08-01
• Completion: 2025-09-01
• First posted: 2025-03-10
• Last updated: 2025-03-10

Locations

1 site across 1 country: China