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

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.

Study Overview

• Status: Completed
• Conditions: Obesity and Overweight
• Intervention / Treatment: Drug: HDM1005 injection or placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Hefei, China
    • The Second Affiliated Hospital of Anhui Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HDM1005 injection dose level 1; HDM1005 injection or placebo dose level 1 once subcutaneous injection	Drug: HDM1005 injection or placebo; HDM1005 injection or placebo isubcutaneous injection once
Experimental: HDM1005 injection dose level 2; HDM1005 injection or placebo dose level 2 once subcutaneous injection	Drug: HDM1005 injection or placebo; HDM1005 injection or placebo isubcutaneous injection once
Experimental: HDM1005 injection dose level 3; HDM1005 injection or placebo dose level 3 once subcutaneous injection	Drug: HDM1005 injection or placebo; HDM1005 injection or placebo isubcutaneous injection once
Experimental: HDM1005 injection dose level 4; HDM1005 injection or placebo dose level 4 once subcutaneous injection	Drug: HDM1005 injection or placebo; HDM1005 injection or placebo isubcutaneous injection once
Experimental: HDM1005 injection dose level 5; HDM1005 injection or placebo dose level 5 once subcutaneous injection	Drug: HDM1005 injection or placebo; HDM1005 injection or placebo isubcutaneous injection once
Experimental: HDM1005 injection dose level 6; HDM1005 injection or placebo dose level 6 once subcutaneous injection	Drug: HDM1005 injection or placebo; HDM1005 injection or placebo isubcutaneous injection once
Experimental: HDM1005 injection dose level 7; HDM1005 injection or placebo dose level 7 once subcutaneous injection	Drug: HDM1005 injection or placebo; HDM1005 injection or placebo isubcutaneous injection once

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	Baseline to day 29

Collaborators and Investigators

• Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Wei Hu, Doctor, The Second Hospital of Anhui Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2024
• Primary Completion (Actual): August 6, 2024
• Study Completion (Actual): September 26, 2024

Study Registration Dates

• First Submitted: May 31, 2024
• First Submitted That Met QC Criteria: October 11, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 8, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: HDM1005-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No