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COMPLETED
NCT06253546
PHASE1

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

Sponsor: Teva Branded Pharmaceutical Products R&D LLC

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2024-03-28

Completion Date

2025-06-12

Last Updated

2026-06-30

Healthy Volunteers

No

Conditions

Interventions

DRUG

TV-44749 318mg

Pharmaceutical form: extended-release injectable suspension Route of administration: subcutaneous injection

DRUG

Oral Olanzapine 10mg/day

Pharmaceutical form: tablet Route of administration: oral

DRUG

TV-44749 425mg

Pharmaceutical form: extended-release injectable suspension Route of administration: subcutaneous injection

DRUG

Oral Olanzapine 15mg/day

Pharmaceutical form: tablet Route of administration: oral

DRUG

TV-44749 531mg

Pharmaceutical form: extended-release injectable suspension Route of administration: subcutaneous injection

DRUG

Oral Olanzapine 20mg/day

Pharmaceutical form: tablet Route of administration: oral

Locations (6)

Teva Investigational Site 88049

Beijing, China

Teva Investigational Site 88048

Beijing, China

Teva Investigational Site 88047

Guangzhou, China

Teva Investigational Site 88046

Shanghai, China

Teva Investigational Site 88050

Wuhan, China

Teva Investigational Site 88056

Xi'an, China