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A Safety, Tolerability, Pharmacokinetics/Pharmacodynamics Study of HEC169584 Capsules in Healthy Subjects

NCT07099118 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2026-04-27

No results posted yet for this study

Summary

The safety, tolerability, and pharmacokinetic/pharmacodynamic (PK/PD) characteristics study of HEC169584 capsules in healthy subjects .

Conditions

  • Non - Alcoholic Steatohepatitis

Interventions

DRUG

HEC169584 capsule

Each dose of HEC83518 will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.

DRUG

placebo

The placebo will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.

Sponsors & Collaborators

  • Sunshine Lake Pharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • DongYang Liu, doctor · Peking University Third Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-09-03
Primary Completion
2026-12-30
Completion
2027-03-06

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT07099118 on ClinicalTrials.gov