Active not recruitingPhase 1

A Pharmacokinetic Study of HDM1005 Injection at Different Injection Sites

Lead sponsor

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Asset

HDM1005

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

Estimated enrollment

135

Study population

Healthy volunteers, Obesity / overweight

Eligibility highlights

•BMI 19-35

Primary endpoints

•Cmax•AUC(0-t)•AUC(0-∞)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07828197

Org study IDHDM1005-106

Timeline

Milestones

Study start2026-09-03actual

Study first posted2026-09-18actual

Last update posted2026-10-01actual

Primary completion2026-10estimated (month precision)

Study completion2026-11estimated (month precision)

Assets

Investigational agents

HDM1005

Who this study enrolls

Healthy volunteersObesity / overweight

Who can enroll

Minimum age18 Years

Maximum age55 Years

SexAll

Healthy volunteersAccepted

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.

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

8 endpoints

Primary/protocol endpoint

Cmax

Time frame:Up to Day 29

concentration, descriptive

Primary/protocol endpoint

AUC(0-t)

Time frame:Up to Day 29

concentration, descriptive

Primary/protocol endpoint

AUC(0-∞)

Time frame:Up to Day 29

concentration, descriptive

Secondary/protocol endpoint

Tmax

Time frame:Up to Day 29

concentration, descriptive

Secondary/protocol endpoint

t1/2

Time frame:Up to Day 29

concentration, descriptive

Secondary/protocol endpoint

CL/F

Time frame:Up to Day 29

descriptive

Secondary/protocol endpoint

Vz/F

Time frame:Up to Day 29

descriptive

Secondary/protocol endpoint

Adverse events (AEs)

Time frame:Up to Day 29

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.