Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06389942
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-02-25
Brief Title:
Single Ascending Dose Study of 9MW3011 in Chinese Healthy Subject
Sponsor:
Mabwell Shanghai Bioscience Co Ltd
Organization:
Mabwell Shanghai Bioscience Co Ltd
Study Overview
Official Title:
A Single-center Randomized Double-Blind Placebo-Controlled Phase 1 Single Ascending Dose Study to Evaluate Safety Tolerability Pharmacokinetics Pharmacodynamics and Immunogenicity Characteristics of 9MW3011 in Healthy Volunteers
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objectives of the study are to evaluate the safety tolerability pharmacokinetics pharmacodynamics and immunogenicity of single ascending intravenous IV doses of 9MW3011 in Chinese healthy volunteers
Detailed Description:
The single ascending doseSAD study will comprise 6 dose cohorts of 8 healthy volunteers each In each cohort subjects will be randomized in a 62 ratio to receive 9MW3011 or placebo via intravenous infusion
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None