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

NCT06867393 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-03-10

No results posted yet for this study

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.

Conditions

  • Healthy Subjects

Interventions

DRUG

HL-003 tablet Placeco

100mg、250mg、500mg、1000mg、1500mg，SAD

DRUG

HL-003 tablet

25mg、100mg、250mg、500mg、1000mg、1500mg，SAD

Sponsors & Collaborators

  • Shanghai Kechow Pharma, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-28
Primary Completion
2025-08-31
Completion
2025-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06867393 on ClinicalTrials.gov