Safety, Tolerability, and Pharmacokinetic Study of TV-44749 in Chinese Patients With Schizophrenia - Trial NCT06253546
Access comprehensive clinical trial information for NCT06253546 through Pure Global AI's free database. This Phase 1 trial is sponsored by Teva Branded Pharmaceutical Products R&D, Inc. and is currently Recruiting. The study focuses on Schizophrenia. Target enrollment is 36 participants.
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Study Focus
Sponsor & Location
Teva Branded Pharmaceutical Products R&D, Inc.
Timeline & Enrollment
Phase 1
Mar 20, 2024
Feb 08, 2025
Primary Outcome
Period 2: Number of Participants with Treatment Emergent Adverse Events (TEAEs),Period 2: Number of Participants with Treatment Emergent Serious Adverse Events (SAEs),Period 2: Number of Participants with Injection Site Adverse Events
Summary
Primary Objective:
 
 To evaluate the safety and tolerability of single doses of TV-44749 for subcutaneous (sc) use
 in Chinese participants with schizophrenia.
 
 Secondary Objectives:
 
 - To evaluate the pharmacokinetics (PK) of single doses of TV-44749 administered sc.
 
 - To evaluate the pharmacokinetics of oral olanzapine tablets following multiple dose
 administration.
 
 - To monitor the safety and tolerability of multiple doses of oral olanzapine tablets
 given in the study.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06253546
Non-Device Trial