Evaluating Safety, Tolerability and Pharmacokinetic of Multiple Ascending Doses of VV119

PHASE1RecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

July 16, 2024

Primary Completion Date

December 1, 2025

Study Completion Date

December 1, 2025

Conditions
Schizophrenia
Interventions
DRUG

VV119 Placebo (in healthy adult subjects)

"VV119 0.5 mg Group:2 subjects will receive VV119 Placebo 0.5 mg, orally once daily for 14 days.~VV119 1 mg Group:2 subjects will receive VV119 Placebo 1 mg, orally once daily for 14 days."

DRUG

VV119 (in healthy adult subjects)

"VV119 0.5 mg Group:6 subjects will receive VV119 0.5 mg, orally once daily for 14 days.~VV119 1 mg Group:6 subjects will receive VV119 1 mg, orally once daily for 14 days."

DRUG

VV119(in adult patients with schizophrenia)

VV119 2 mg Group:6 subjects will receive 2 0.5mgVV119 capsules on the first four days, then take 1 2mgVV119 capsules and 1 0.5mg VV119 Placebo from the fifth day to the 28th day, orally once daily, VV119 4 mg Group:6 subjects will receive 2 0.5mgVV119 capsules on the first four days, take 1 2mgVV119 capsules and 1 0.5mg VV119 Placebo from the fifth day to the seventh day , then 2 2mgVV119 capsules and 1 0.5mg VV119 Placebo from the eighth day to the 28th day ,orally once daily, VV119 6 mg Group:6 subjects will receive 2 0.5mgVV119 capsules on the first three days,take 1 2mgVV119 capsules and 1 0.5mg VV119 Placebo from the forth day to the fifth day , take 2 2mgVV119 capsules and 1 0.5mg VV119 Placebo from the sixth day to the seventh day , then 3 2mgVV119 capsules and 1 0.5mg VV119 Placebo from the eighth day to the 28th day ,orally once daily.

DRUG

VV119 Placebo (in adult patients with schizophrenia)

VV119 2 mg Group:2 subjects will receive 1 0.5mgVV119 capsules and 1 0.5mg VV119 Placebo on the first four days, then take 1 2mgVV119 Placebo and 1 0.5mg VV119 capsules from the fifth day to the 28th day, orally once daily, VV119 4 mg Group:2 subjects will receive 1 0.5mgVV119 capsules and 1 0.5mg VV119 Placebo on the first four days, take 1 2mgVV119 Placebo and 1 0.5mg VV119 capsules from the fifth day to the seventh day , then 2 2mgVV119 Placebo and 1 0.5mg VV119 capsules from the eighth day to the 28th day ,orally once daily, VV119 6 mg Group:2 subjects will receive 1 0.5mgVV119 capsules and 1 0.5mg VV119 Placebo on the first three days, take 1 2mgVV119 Placebo and 1 0.5mg VV119 capsules from the forth day to the fifth day ,take 2 2mgVV119 capsules and 1 0.5mg VV119 Placebo from the sixth day to the seventh day, then 3 2mgVV119 Placebo and 1 0.5mg VV119 capsules from the eighth day to the 28th day ,orally once daily.

Trial Locations (4)

Unknown

RECRUITING

Beijing Anding Hospital of Capital Medical University, Beijing

RECRUITING

Beijing Anding Hospital of Capital Medical University, Beijing

RECRUITING

Beijing Huilongguan Hospital, Beijing

RECRUITING

Xi'an Mental Health Center, Xi’an

All Listed Sponsors
lead

Vigonvita Life Sciences

INDUSTRY