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OpenTrials
Active, not recruiting

NCT Number: NCT07828197

A Pharmacokinetic Study of HDM1005 Injection at Different Injection Sites

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Second Affiliated Hospital of Anhui Medical University

Hefei, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

HDM1005

Drug

2.0 mg, SC, single dose

Primary outcomes

  1. Cmax

    Time frame: Up to Day 29

    Maximum observed concentration

  2. AUC(0-t)

    Time frame: Up to Day 29

    Area under the curve from time 0 to t hour

  3. AUC(0-∞)

    Time frame: Up to Day 29

    Area under the curve from time 0 hour to ∞

Secondary outcomes

  1. Tmax

    Time frame: Up to Day 29

    Time to maximum plasma concentration

  2. t1/2

    Time frame: Up to Day 29

    Half life

  3. CL/F

    Time frame: Up to Day 29

    Apparent Clearance

  4. Vz/F

    Time frame: Up to Day 29

    Apparent volume of distribution

  5. Adverse events (AEs)

    Time frame: Up to Day 29

    Number of subjects reporting AEs

Sponsors and collaborators

Lead sponsor

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 18, 2026
Registry last updated
Sep 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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