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

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.1 个研究点分布在 1 个国家目标入组 65 人开始时间: 2024年3月19日最近更新: 2025年12月16日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
入组人数: 65
试验地点: 1
主要终点: Safety Outcomes

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 55 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•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

排除标准

•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
•Blood donors within 3 months prior to randomization
•In the Investigator's opinion, the subject is not suitable to participate in any other circumstances of the trial