A Pharmacokinetic Study of HDM1005 Injection in Participants With Impaired Renal Function and Healthy Participants

Sponsor
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Study ID
NCT07559240
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • HDM1005 — DRUG
    2.0 mg, SC, single dose

Study Details

The purpose of this study is to evaluate the pharmacokinetic profile and safety of a single subcutaneous injection of HDM1005 solution in participants with impaired kidney function compared to healthy participants.

Key Dates

First listed
Apr 30, 2026
Start date
May 15, 2026
Status verified
May 2026
Primary completion
Jun 12, 2026
Completion
Jul 31, 2026

Study Design

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

Arms

  • Experimental: Group 1 - Healthy Control
  • Experimental: Group 2 - Moderate Renal Impairment
  • Experimental: Group 3 - Severe Renal Impairment

Primary Outcome Measure

Maximum Concentration (Cmax) [ Time Frame: Up to Day 29 ]

Central Contacts

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