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This is a randomized, double-blind, placebo-controlled, single-dose, dose-escalation Phase Ia clinical study. It is aimed to evaluate the safety, tolerability, PK and PD characteristics of HDM1005 injection in healthy adult subjects.
In this study, 7 dose cohorts will be set up, with 10 subjects in each cohort, and subjects in each cohort will be randomized in a 4:1 ratio to receive HDM1005 injection or placebo via subcutaneous injection. Proposed dose cohorts include: Cohort 1 , Cohort 2 , Cohort 3 , Cohort 4, Cohort 5 , Cohort 6 , and Cohort 7. Scientific review committee (SRC) will be established to review the data in a blinded manner to confirm whether to proceed with the next cohort and determine the dose for the next cohort according to both protocol and data obtained from previous cohorts. Administration of higher dose cohorts will only be allowed when the safety and tolerability of the lower dose cohorts have been established and are acceptable. SRC composes representatives from the Sponsor (including but not limited to medical responsible, statistician, clinical pharmacologist) and investigator(s). External consultant may be invited as SRC member per specific scientific question.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HDM1005 injection dose level 1 | Experimental | HDM1005 injection or placebo dose level 1 once subcutaneous injection |
|
| HDM1005 injection dose level 2 | Experimental | HDM1005 injection or placebo dose level 2 once subcutaneous injection |
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| HDM1005 injection dose level 3 | Experimental | HDM1005 injection or placebo dose level 3 once subcutaneous injection |
|
| HDM1005 injection dose level 4 | Experimental | HDM1005 injection or placebo dose level 4 once subcutaneous injection |
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| HDM1005 injection dose level 5 | Experimental | HDM1005 injection or placebo dose level 5 once subcutaneous injection |
|
| HDM1005 injection dose level 6 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HDM1005 injection or placebo | Drug | HDM1005 injection or placebo isubcutaneous injection once |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety Outcomes | The incidence, severity, and causality of adverse events (AE) and serious adverse events (SAEs) occurring during treatment, resulting in early termination of TEAEs, resulting in death of TEAEs; etc. | Signing informed until day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| PK Outcomes | PK parameters include, but are not limited to Area under the plasma concentration versus time curve (AUC) | 0-672 hour(s) |
| PD Outcomes | Changes in body weight, body mass index (BMI), fasting glucose, fasting insulin, fasting C-peptide, blood lipids compared to baseline |
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Inclusion Criteria:
Exclusion Criteria:
Previous diagnosis of type 1, type 2, or other types of diabetes
History or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia, or multiple endocrine adenomatosis type 2
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
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)
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
Patients who have undergone major surgery within 3 months before signing the ICF, or who plan to undergo surgery during the study period
Known allergy to any component of the investigational drug or prior history of severe drug allergy
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.
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)
Any of the auxiliary test indicators during the screening period meet the following criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Wei Hu, Doctor | The Second Hospital of Anhui Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Anhui Medical University | Hefei | China |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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HDM1005 injection or placebo dose level 6 once subcutaneous injection |
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| HDM1005 injection dose level 7 | Experimental | HDM1005 injection or placebo dose level 7 once subcutaneous injection |
|
| Baseline to day 29 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |