Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-03-03 @ 6:44 PM
Study NCT ID:
NCT06938269
Status:
RECRUITING
Last Update Posted:
2025-11-20
First Post:
2025-04-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate MWN109 Tablets in Healthy Adult Participants
Sponsor:
Shanghai Minwei Biotechnology Co., Ltd
Organization:
Study Overview
Official Title:
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MWN109 Tablets in Healthy Adult Participants
Status:
RECRUITING
Status Verified Date:
2025-11
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:
This is a Phase 1, randomized, double-blind, placebo-controlled, single-and-multiple ascending dose study in which the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of orally administered MWN109 tablets will be assessed in healthy adult participants.
Detailed Description:
Approximately 60 healthy volunteers are expected to be enrolled into this study. The study will consist of 2 parts: a single ascending dose (SAD) part and a multiple ascending dose (MAD) part.The SAD part will be a single-dose, sequential-cohort study. The MAD Part will be a multiple-dose, sequential-cohort study. Initiation and dose levels of MAD Part will be determined in the safety review and dose escalation meeting by the Safety Review Committee based on the review of safety, tolerability, and PK data from SAD Part.
The entire study duration per participant is estimated to be a maximum of 8 weeks for the single ascending dose (SAD) part and 12 weeks for the multiple ascending dose (MAD) part. The end of study is defined as the date of the last visit of the last participant in the study.
The entire study duration per participant is estimated to be a maximum of 8 weeks for the single ascending dose (SAD) part and 12 weeks for the multiple ascending dose (MAD) part. The end of study is defined as the date of the last visit of the last participant in the study.
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?: