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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
65
HDM1005 injection or placebo isubcutaneous injection once
The Second Affiliated Hospital of Anhui Medical University
Hefei, China
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.
Time frame: Signing informed until day 29
PK Outcomes
PK parameters include, but are not limited to Area under the plasma concentration versus time curve (AUC)
Time frame: 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
Time frame: Baseline to day 29
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