Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06504290
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-02
Brief Title:
Evaluating Safety Tolerability and Pharmacokinetic of Multiple Ascending Doses of VV119
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase I Clinical Study Evaluating the Safety Tolerability and Pharmacokinetics of VV119 Capsules with Multiple Ascending Doses in Chinese Healthy Adult Subjects and Patients with Schizophrenia
Status:
RECRUITING
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 study will consist of 2 parts Part Ⅰ-in healthy adult subjects Part Ⅱ-in adult patients with schizophrenia
Detailed Description:
Part Ⅰ was designed as single-center randomized double-blind placebo-controlled dose-escalation trial to assess the safety tolerability pharmacokinetics PK of multiple doses of VV119 in Chinese healthy adult subjects
Part Ⅱ was designed as multicenter randomized double-blind placebo-controlled dose-escalation trial to assess the safety tolerability pharmacokinetics PK and efficacy of multiple doses of VV119 in adult patients with schizophrenia
Part Ⅱ was designed as multicenter randomized double-blind placebo-controlled dose-escalation trial to assess the safety tolerability pharmacokinetics PK and efficacy of multiple doses of VV119 in adult patients with schizophrenia
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