Phase Ia Clinical Study of HDM1005 Injection

NCT06640647 | Completed Phase 1 FDA Drug

• 1 other identifier: HDM1005-101
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity and Overweight

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• PK Outcomes

  0-672 hour(s)

• PD Outcomes

  Baseline to day 29

Study Arms (7)

HDM1005 injection dose level 1

EXPERIMENTAL

HDM1005 injection or placebo dose level 1 once subcutaneous injection

Drug: HDM1005 injection or placebo

HDM1005 injection dose level 2

EXPERIMENTAL

HDM1005 injection or placebo dose level 2 once subcutaneous injection

Drug: HDM1005 injection or placebo

HDM1005 injection dose level 3

EXPERIMENTAL

HDM1005 injection or placebo dose level 3 once subcutaneous injection

Drug: HDM1005 injection or placebo

HDM1005 injection dose level 4

EXPERIMENTAL

HDM1005 injection or placebo dose level 4 once subcutaneous injection

Drug: HDM1005 injection or placebo

HDM1005 injection dose level 5

EXPERIMENTAL

HDM1005 injection or placebo dose level 5 once subcutaneous injection

Drug: HDM1005 injection or placebo

HDM1005 injection dose level 6

EXPERIMENTAL

HDM1005 injection or placebo dose level 6 once subcutaneous injection

Drug: HDM1005 injection or placebo

HDM1005 injection dose level 7

EXPERIMENTAL

HDM1005 injection or placebo dose level 7 once subcutaneous injection

Drug: HDM1005 injection or placebo

Interventions

HDM1005 injection or placebo DRUG

HDM1005 injection or placebo isubcutaneous injection once

HDM1005 injection dose level 1; HDM1005 injection dose level 2; HDM1005 injection dose level 3; HDM1005 injection dose level 4; HDM1005 injection dose level 5; HDM1005 injection dose level 6; HDM1005 injection dose level 7

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The Second Affiliated Hospital of Anhui Medical University

Hefei, China

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Wei Hu, Doctor

  The Second Hospital of Anhui Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: October 15, 2024
• Study Start: March 19, 2024
• Primary Completion: August 6, 2024
• Study Completion: September 26, 2024
• Last Updated: December 16, 2025

Record last verified: 2024-10

Locations

CN (1)