Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06637020
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-05-31
Brief Title:
Phase Ib Clinical Study of HDM1005 Injection
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Phase Ib Clinical Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of Multiple Subcutaneous SC Doses of HDM1005 Injection in Overweight or Obese Subjects
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 41 ratio to receive either HDM1005 injection or placebo subcutaneously The proposed dose cohorts are as follows cohort a 05 mg cohort b 10 mg cohort c 20 mg cohort d 40 mg cohort e 80 mg Cohorts de 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None