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Phase Ia Clinical Study of HDM1005 Injection
A Randomized, Double-Blind, Dose-Escalation, Placebo-Controlled Phase Ia Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HDM1005 After a Single Subcutaneous Dose in Healthy Subjects
Asset
HDM1005
Subcutaneous · GLP-1 / GIP dual
Listed sites
1
Recruiting sites
—
Enrollment
65
actual
Study population
Healthy volunteers
Key I/E criterion
•BMI 19-32
Primary endpoint
•Safety Outcomes
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Chinese subjects aged 18 to 55 (including 18 and 55 years old), male or female subjects
2. BMI at the time of screening was between 19.0 and 32.0 kg/m2 (including 19.0 and 32.0 kg/m2), and the weight of female subjects was ≥45 kg and that of male subjects was ≥50 kg
3. Normal or abnormal vital signs, physical examination, laboratory examination, 12-lead ECG and chest imaging during the screening period have no clinical significance
4. Fertile female subjects, from 14 days before signing the ICF to 2 months after the administration of the drug, have taken and agreed to continue to take effective contraceptive measures, and have no family planning or egg donation plan; Male subjects had no plans to have children, no plans to donate sperm, and agreed to use highly effective contraceptive methods from signing ICF to 4 months after dosing
5. Be able to understand the procedures and methods of this study, voluntarily sign ICF, and be willing to strictly follow the requirements of clinical trial protocol to complete relevant procedures
Exclusion criteria
1. Previous diagnosis of type 1, type 2, or other types of diabetes
2. History or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia, or multiple endocrine adenomatosis type 2
3. As determined by the investigator, the subject has a co-existing disease or condition that affects gastric emptying or gastrointestinal nutrient absorption. Or a history of acute pancreatitis or acute gallbladder disease within 3 months prior to signing the ICF
4. Had any malignancy within 5 years prior to signing the ICF (except for basal cell carcinoma that has received curative treatment and is considered cured)
5. Cardiovascular and cerebrovascular diseases, gastrointestinal diseases, diabetes mellitus, medullary thyroid cancer, thyroid C cell hyperplasia, multiple endocrine adenomatosis type 2, chronic pancreatitis, and malignant tumors with obvious clinical significance were present; And any respiratory, neurological, urogenital, hematological, or endocrine disorders that may affect the safety of the subject or the findings of the study
6. Patients who have undergone major surgery within 3 months before signing the ICF, or who plan to undergo surgery during the study period
7. Known allergy to any component of the investigational drug or prior history of severe drug allergy
8. Drugs (including prescription drugs, over-the-counter drugs, Chinese herbs, health products, etc.) that have been used within 3 months before signing the ICF and have been determined by researchers to significantly affect body weight and blood sugar.
9. Participated in any clinical trial within 30 days prior to randomization or within 5 half-lives (whichever is older) after the last administration of the investigational drug in the clinical trial (except those who signed ICF and did not receive drug or device intervention)
10. Any of the auxiliary test indicators during the screening period meet the following criteria:
1. Alanine aminotransferase >1.5x upper limit of normal (ULN), or ASpartate aminotransferase >1.5x ULN, alkaline phosphatase >1.5x ULN, or total bilirubin >1.5x ULN (subjects with Gilbert's syndrome can participate in this study if direct bilirubin ≤ULN);
2. calcitonin ≥50 ng/L;
3. Blood amylase or lipase >ULN;
4. Thyroid stimulating hormone >6.0 mIU/L or <0.4 mIU/L;
5. Hemoglobin a1C (HbA1c) ≥6.0%; Fasting blood glucose ≥6.1 mmol/L or < 3.9 mmol/L; Or OGTT 2 h blood glucose ≥7.8 mmol/L;
6. eGFR < 60 mL/min/1.73m2;
7. Male QTcF>450 ms, female QTcF>470 ms
11. People tested positive for infectious diseases 12 Habitual smokers, alcoholics and drug abusers;
13. Pregnant or lactating women 14. Blood donors within 3 months prior to randomization 15. In the Investigator's opinion, the subject is not suitable to participate in any other circumstances of the trial
Endpoints (3)
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.
Coverage by outcome category
Safety / tolerability / PK
2 endpointsSafety Outcomes
Time frame:Signing informed until day 29
descriptive
PK Outcomes
Time frame:0-672 hour(s)
descriptive
Other (unclassified)
1 endpointPD Outcomes
Time frame:Baseline to day 29
descriptive
Provenance
Sources
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 July 1, 2026 snapshot.