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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Hefei, China
- The Second Affiliated Hospital of Anhui Medical University
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Chinese subjects aged 18 to 55 (including 18 and 55 years old), male or female subjects
- 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
- Normal or abnormal vital signs, physical examination, laboratory examination, 12-lead ECG and chest imaging during the screening period have no clinical significance
- 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
- 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:
- 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:
- 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);
- calcitonin ≥50 ng/L;
- Blood amylase or lipase >ULN;
- Thyroid stimulating hormone >6.0 mIU/L or <0.4 mIU/L;
- 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;
- eGFR < 60 mL/min/1.73m2;
- Male QTcF>450 ms, female QTcF>470 ms
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: HDM1005 injection dose level 1
HDM1005 injection or placebo dose level 1 once subcutaneous injection
|
HDM1005 injection or placebo isubcutaneous injection once
|
|
Experimental: HDM1005 injection dose level 2
HDM1005 injection or placebo dose level 2 once subcutaneous injection
|
HDM1005 injection or placebo isubcutaneous injection once
|
|
Experimental: HDM1005 injection dose level 3
HDM1005 injection or placebo dose level 3 once subcutaneous injection
|
HDM1005 injection or placebo isubcutaneous injection once
|
|
Experimental: HDM1005 injection dose level 4
HDM1005 injection or placebo dose level 4 once subcutaneous injection
|
HDM1005 injection or placebo isubcutaneous injection once
|
|
Experimental: HDM1005 injection dose level 5
HDM1005 injection or placebo dose level 5 once subcutaneous injection
|
HDM1005 injection or placebo isubcutaneous injection once
|
|
Experimental: HDM1005 injection dose level 6
HDM1005 injection or placebo dose level 6 once subcutaneous injection
|
HDM1005 injection or placebo isubcutaneous injection once
|
|
Experimental: HDM1005 injection dose level 7
HDM1005 injection or placebo dose level 7 once subcutaneous injection
|
HDM1005 injection or placebo isubcutaneous injection once
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Safety Outcomes
Time Frame: Signing informed until day 29
|
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
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PK Outcomes
Time Frame: 0-672 hour(s)
|
PK parameters include, but are not limited to Area under the plasma concentration versus time curve (AUC)
|
0-672 hour(s)
|
|
PD Outcomes
Time Frame: Baseline to day 29
|
Changes in body weight, body mass index (BMI), fasting glucose, fasting insulin, fasting C-peptide, blood lipids compared to baseline
|
Baseline to day 29
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Wei Hu, Doctor, The Second Hospital of Anhui Medical University
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- HDM1005-101
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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