A Pharmacokinetic Study of HDM1005 Injection at Different Injection Sites

NCT07828197 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: HDM1005-106
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the relative bioavailability of a single subcutaneous injection of HDM1005 solution at different injection sites (upper arm and thigh)by using the abdomen subcutaneous injection as a control.

Conditions

Overweight and/or Obesity; Healthy Participants

Outcome Measures

Primary Outcomes (3)

• Cmax

  Maximum observed concentration

  Up to Day 29

• AUC(0-t)

  Area under the curve from time 0 to t hour

  Up to Day 29

• AUC(0-∞)

  Area under the curve from time 0 hour to ∞

  Up to Day 29

Secondary Outcomes (5)

• Tmax

  Up to Day 29

• t1/2

  Up to Day 29

• CL/F

  Up to Day 29

• Vz/F

  Up to Day 29

• Adverse events (AEs)

  Up to Day 29

Study Arms (3)

Cohort 1 (Abdomen)

EXPERIMENTAL

Subject received a single subcutaneous injection of HDM1005 solution (0.5 mL, 2 mg) at abdomen.

Drug: HDM1005

Cohort 2 (Upper arm)

EXPERIMENTAL

Subject received a single subcutaneous injection of HDM1005 solution (0.5 mL, 2 mg) at upper arm.

Drug: HDM1005

Cohort 3 (Thigh)

EXPERIMENTAL

Subject received a single subcutaneous injection of HDM1005 solution (0.5 mL, 2 mg) at thigh.

Drug: HDM1005

Interventions

HDM1005 DRUG

2.0 mg, SC, single dose

Cohort 1 (Abdomen); Cohort 2 (Upper arm); Cohort 3 (Thigh)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged between 18 and 55 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).
• In the investigator's opinion, the participants do not have any clinically significant abnormal findings 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.

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 within 3 months prior to screening.
• History of 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.
• 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.
• History of specific allergy (such as asthma, urticaria, eczema, etc.) or allergic constitution; or known intolerance or allergy to any component of the investigational drug or GLP-1 receptor (GLP-1R) agonists; or have a history of severe drug allergies.
• 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 or positive urine drug test at screening.
• Use of prescription or over-the-counter medications, health supplements, or herbal medicines within 2 weeks prior to IMP administration, or still within 5 half-lives of such medications.
• Participation in any clinical trial and use of investigational product within 3 months prior to screening, or still within 5 half-lives of the investigational product from a previous trial at the time of screening (whichever is longer).
• Female participants who are breastfeeding or pregnant.
• 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)

The Second Affiliated Hospital of Anhui Medical University

Hefei, China

Location

Study Design

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

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 18, 2026
• Study Start: September 3, 2026
• Primary Completion: October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)