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

NCT07559240 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: HDM1005-105
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obese; Overweight

Outcome Measures

Primary Outcomes (2)

• Maximum Concentration (Cmax)

  Cmax of HDM1005

  Up to Day 29

• Area Under the Concentration Time Curve From Time Zero to t [ AUC(0- t)]

  AUC(0- t) of HDM1005

  Up to Day 29

Secondary Outcomes (3)

• Apparent clearance (CL/F)

  Up to Day 29

• Apparent distribution(Vz/F)

  Up to Day 29

• Adverse events (AEs)

  Up to Day 29

Study Arms (3)

Group 1 - Healthy Control

EXPERIMENTAL

Drug: HDM1005

Group 2 - Moderate Renal Impairment

EXPERIMENTAL

Drug: HDM1005

Group 3 - Severe Renal Impairment

EXPERIMENTAL

Drug: HDM1005

Interventions

HDM1005 DRUG

2.0 mg, SC, single dose

Group 1 - Healthy Control; Group 2 - Moderate Renal Impairment; Group 3 - Severe Renal Impairment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 18 and 45 years (inclusive), regardless of gender.
• Body weight ≥50.0 kg for males and ≥45.0 kg for females; body mass index (BMI) between 19.0 and 35.0 kg/m² (inclusive).
• For participants with renal impairment: prior diagnosis of chronic kidney disease (CKD). Absolute GFR calculated by CKD-EPI and BSA formula: ≥30 and \<60 mL/min for moderate impairment; ≥15 and \<30 mL/min for severe impairment.
• For participants with normal renal function: aged 18 to 75 years (inclusive); body weight ≥50.0 kg (male) or ≥45.0 kg (female); BMI 19.0-35.0 kg/m².
• In the investigator's opinion, suitable for the study based on medical history, clinical laboratory tests, vital signs, 12-lead ECG, and physical examination at screening.
• Provide signed informed consent before any trial procedures; fully understand the trial content, procedures, and possible adverse reactions.
• Able to communicate well with the investigator and understand and comply with all study requirements.

You may not qualify if:

• Personal or family history of medullary thyroid carcinoma (MTC), thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2).
• History of chronic pancreatitis, or an episode of acute pancreatitis or acute cholecystitis within 3 months prior to screening.
• Severe hypoglycemic events or recurrent hypoglycemic events (≥3 episodes per week) within 3 months prior to screening.
• For the renal impairment group: presence of obstructive urinary tract disease, acute kidney injury, or other clinically significant systemic diseases beyond chronic kidney disease and its complications, which in the investigator's opinion make the participant unsuitable. For the normal renal function group: presence of clinically significant diseases involving any of the following systems at screening (including but not limited to respiratory, circulatory, digestive, hematopoietic, endocrine, immune, skin, nervous, psychiatric, ear-nose-throat, etc.), which in the investigator's opinion make the participant unsuitable.
• Known intolerance or allergy to GLP-1R and/or GIPR agonists, or known allergy to HDM1005 or any component of the formulation.
• Major surgery within 6 months prior to screening, or incomplete healing of surgical incisions, or planned surgery during the study.
• Blood donation or blood loss ≥400 mL, or use of blood products within 3 months prior to screening or between screening and dosing.
• History of drug abuse (e.g., morphine, ketamine, tetrahydrocannabinolic acid, methamphetamine, methylenedioxymethamphetamine, cocaine) or positive urine drug test at screening.
• History of needle phobia or hemophobia, difficulty with blood collection, or inability to tolerate venipuncture.
• Any other condition (medical, psychological, psychiatric, social, or geographic factors) that, in the investigator's opinion, makes the participant unsuitable for the study.

Sponsors & Collaborators

• Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Peking University Third Hospital

Beijing, 100191, China

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Guiyu Liu

CONTACT

+86-0571 89908523; liuguiyu@eastchinapharm.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2026
• First Posted: April 30, 2026
• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): June 12, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)