Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-25 @ 4:29 AM
NCT ID:
NCT06637020
Brief Summary:
This study is a randomized, double-blind, placebo-controlled, multiple-dose, dose-escalation study in overweight or obese subjects to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) characteristics of HDM1005 injection in overweight or obese subjects.
Detailed Description:
This study is designed to consist of 5 dose cohorts, with 10 subjects in each cohort. Within each cohort, subjects are randomized in a 4:1 ratio to receive either HDM1005 injection or placebo subcutaneously. The proposed dose cohorts are as follows: cohort a (0.5 mg), cohort b (1.0 mg), cohort c (2.0 mg), cohort d (4.0 mg), cohort e (8.0 mg). Cohorts d,e will use a titration method to gradually reach the target dose. After obtaining safety and tolerability data for at least 14 days following multiple ascending dose (MAD) in the previous dose cohort, the dose to be administered and titration strategy for the next dose cohort are jointly determined by the investigator and the sponsor. Administration is allowed in the higher dose cohort only if the data from the lower dose cohort is indicative of safety. If necessary, the sponsor may continue to explore higher dose cohorts with the agreement of both the investigator and the sponsor.
Study:
NCT06637020
Study Brief:
Protocol Section:
NCT06637020