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NCT06253546

Safety, Tolerability, and Pharmacokinetic Study of TV-44749 in Chinese Patients With Schizophrenia

A Phase 1, Single Dose, Parallel Cohort Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TV-44749, Olanzapine for Extended-Release Injectable Suspension for Subcutaneous Use, in Chinese Patients With Schizophrenia
Teva Branded Pharmaceutical Products R&D, Inc.·Phase 1·ClinicalTrials.gov·drugRecruiting
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Study focus
Disease/Condition
Schizophrenia
Drug/Device/Intervention
TV-44749
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Location
Beijing,Guangzhou,Shanghai,Wuhan Shi, China
Timeline & enrollment
Phase
Phase 1
Start date
Mar 20, 2024
End date
Feb 08, 2025
Enrollment
36 participants
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
SchizophreniaSimple schizophreniaSchizophrenia, unspecifiedOther schizophreniaParanoid schizophrenia
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06253546
Type
Non-Device Trial
About this record

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.