NCT04839926

A Single Ascending Dose Study Of CY150112 After Single Oral Administration in Healthy Chinese Subjects

A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Phase I Clinical Trial to Evaluate Safety, Tolerability, and Pharmacokinetics of CY150112 After Single Oral Administration in Healthy Chinese Subjects

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Jiangsu Nhwa Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The primary objective of single ascending dose study is to evaluate the safety and tolerability of CY150112 after single oral administration of different doses in healthy Chinese subjects.

Detailed description

Single administration, double-blinded, placebo-controlled (2 subjects in each group will take placebo,8 subjects in each group will take CY150112) and 6 dose groups (0.5mg, 1.5mg, 4.5mg, 10mg, 18mg and 24mg). This study comprises a screening period (between signing of the informed consent form and Day -1), baseline period (Day -1), treatment period (Days 1-5) and follow-up period(Days 12 or 7 days after discharge ).

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	0.5mg CY150112	single oral CY150112 while fasting on day 1.
DRUG	1.5mg CY150112	single oral CY150112 while fasting on day 1.
DRUG	4.5mg CY150112	single oral CY150112 while fasting on day 1.
DRUG	10mg CY150112	single oral CY150112 while fasting on day 1.
DRUG	18mg CY150112	single oral CY150112 while fasting on day 1.
DRUG	24mg CY150112	single oral CY150112 while fasting on day 1.

Timeline

• Start date: 2021-03-02
• Primary completion: 2021-08-01
• Completion: 2021-08-01
• First posted: 2021-04-09
• Last updated: 2021-04-09

Locations

1 site across 1 country: China