Ignite Creation Date:
2024-10-25 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06640647
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-05-31
Brief Title:
Phase Ia Clinical Study of HDM1005 Injection
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2024-10
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 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
Detailed Description:
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 41 ratio to receive HDM1005 injection or placebo via subcutaneous injection Proposed dose cohorts include Cohort 1 01 mg Cohort 2 025 mg Cohort 3 05 mg Cohort 4 1 mg Cohort 5 25 mg Cohort 6 5 mg and Cohort 7 10 mg 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 investigators External consultant may be invited as SRC member per specific scientific question
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