Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:11 AM
Study NCT ID:
NCT07372703
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-28
First Post:
2026-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Safety, Tolerability, Pharmacokinetics of VV913 Capsules in Chinese Healthy Participants
Sponsor:
Vigonvita Life Sciences
Organization:
Study Overview
Official Title:
A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics of a Single Oral Dose of VV913 Capsules in Chinese Healthy Participants
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-01
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 randomized, double-blind, placebo-controlled, single ascending-dose study to evaluate the safety, tolerability and pharmacokinetics characteristics of VV913 Capsules in healthy adults.
Detailed Description:
The study is designed to enroll 56 participants. The study , conducted as a double-blind study, comprise 7 dose groups with 8 participants each. Participants will be randomly assigned to receive either the VV913 Capsules or placebo in a ratio of 6:2. Dose groups are designed as 1 mg, 2 mg, 4 mg, 8 mg, 15 mg, 25 mg, and 40 mg. Based on observed tolerability and safety data or obtained pharmacokinetic data, adjustments are allowed at all dose levels in the clinical trial.
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?: