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

NCT06253546 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-08-01

No results posted yet for this study

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.

Conditions

Interventions

DRUG

TV-44749

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

DRUG

Oral Olanzapine

Pharmaceutical form: tablet Route of administration: oral

Sponsors & Collaborators

  • Teva Branded Pharmaceutical Products R&D, Inc.

    lead INDUSTRY

Principal Investigators

  • Teva Medical Expert, MD · Teva Branded Pharmaceutical Products R&D, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-28
Primary Completion
2025-06-12
Completion
2025-06-12

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06253546 on ClinicalTrials.gov