A Study to Evaluate the Pharmacokinetics of HRS9531 Injection in Participants With Mild, Moderate, and Normal Hepatic Function

Sponsor
Fujian Shengdi Pharmaceutical Co., Ltd.
Study ID
NCT07540754
Phase
PHASE1
Status
Recruiting
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Conditions

  • Diabetes Mellitus
  • Weight Loss

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • HRS9531 Injection — DRUG
    HRS9531 injection, specified dose on the specified day.

Study Details

This is a Phase I clinical study to compare the pharmacokinetics (PK) of HRS9531 Injection in participants with mild/moderate hepatic impairment and participants with normal hepatic function, and to evaluate the safety of HRS9531 Injection in these participants.

Key Dates

First listed
Apr 20, 2026
Start date
May 26, 2026
Status verified
May 2026
Primary completion
Jan 31, 2027
Completion
Feb 28, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group of Participants with mild hepatic impairment
    Participants with mild hepatic impairment.
  • Experimental: Group of Participants with moderate hepatic impairment
    Participants with moderate hepatic impairment.
  • Experimental: Group of Participants with normal hepatic function
    Participants with normal hepatic function.

Primary Outcome Measure

Maximum concentration (Cmax) [ Time Frame: Post-dose from Day 1 to Day 29. ]

Central Contacts

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