A Trial of HRS-9813 in Healthy Subjects

Sponsor
Guangdong Hengrui Pharmaceutical Co., Ltd
Study ID
NCT06821464
Phase
PHASE1
Status
Completed

Conditions

  • Idiopathic Pulmonary Fibrosis/Progressive Pulmonary Fibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Accepted

Interventions

  • HRS-9813 — DRUG
    Initial dose to planned dose（low dose）
  • HRS-9813 — DRUG
    Initial dose to planned dose（high dose）

Study Details

The study is being conducted to evaluate the safety and pharmacokinetics of HRS-9813 after multiple oral administration in healthy subjects.

Key Dates

First listed
Feb 12, 2025
Start date
Feb 17, 2025
Status verified
Jun 2026
Primary completion
Jul 27, 2025
Completion
Jul 27, 2025

Study Design

Enrollment
45 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment group A
    Low dose
  • Experimental: Treatment group B
    High dose

Primary Outcome Measure

Safety outcomes: Incidence and severity of AEs. [ Time Frame: Day -14 to Day 22 ]