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

NCT06253546 | Completed Phase 1 Results

• 1 other identifier: TV44749-PK-10188
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 6

Brief 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

Schizophrenia

Outcome Measures

Primary Outcomes (3)

• Period 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs)

  An adverse event (AE) was defined as any untoward medical occurrence in a participant who received the study drug without regard to possibility of causal relationship. Treatment-emergent AEs were defined as AEs that occurred after the first dose of study drug was administered in Period 1 through end of the trial. A summary of other non-serious AEs and all serious AEs (SAEs), regardless of causality is located in the Reported AE section.

  Day 1 Up to Day 43

• Period 2: Number of Participants With Treatment Emergent SAEs

  An AE was defined as any untoward medical occurrence in a participant who received the study drug without regard to possibility of causal relationship. The SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. Treatment-emergent AEs were defined as AEs that occurred after the first dose of study drug was administered in Period 1 through end of the trial. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the Reported AE section.

  Day 1 Up to Day 43

• Period 2: Number of Participants With Injection Site AEs

  Injection site AEs included injection site pruritus, induration, warmth, and abscess. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the Reported AE section. All injection site AEs are reported in this outcome measure and the AE module only reports non-serious AEs at the 5% threshold. In the AE module, a participant could have been included for multiple injection site AEs.

  Day 1 Up to Day 43

Secondary Outcomes (11)

• Period 2: Maximum Observed Plasma Drug Concentration (Cmax) of TV-44749

  Day 1 Up to Day 43

• Period 2: Area Under the Plasma Drug Concentration-time Curve (AUC) Over the Period Following Administration on Day 1 to the Time of the Last Measurable Concentration (AUC0-t) of TV-44749

  Day 1 Up to Day 43

• Period 2: AUC of TV-44749 Over the Period Following Administration on Day 1 Extrapolated to Infinity (AUC0-inf)

  Day 1 Up to Day 43

• Period 2: Time to Maximum Observed Concentration (Tmax) of TV-44749

  Day 1 Up to Day 43

• Period 2: Apparent Elimination Half-Life (t½) of TV-44749

  Day 1 Up to Day 43

Study Arms (3)

Cohort 1

EXPERIMENTAL

Period 1: Participants will receive oral olanzapine daily Period 2: Participants will receive subcutaneous (sc) injection of TV-44749

Drug: TV-44749 318mg; Drug: Oral Olanzapine 10mg/day

Cohort 2

EXPERIMENTAL

Period 1: Participants will receive oral olanzapine daily Period 2: Participants will receive sc injection of TV-44749

Drug: TV-44749 425mg; Drug: Oral Olanzapine 15mg/day

Cohort 3

EXPERIMENTAL

Period 1: Participants will receive oral olanzapine daily Period 2: Participants will receive sc injection of TV-44749

Drug: TV-44749 531mg; Drug: Oral Olanzapine 20mg/day

Interventions

TV-44749 318mg DRUG

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

Cohort 1

TV-44749 425mg DRUG

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

Cohort 2

TV-44749 531mg DRUG

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

Cohort 3

Oral Olanzapine 20mg/day DRUG

Pharmaceutical form: tablet Route of administration: oral

Also known as: ZYPREXA

Cohort 3

Oral Olanzapine 10mg/day DRUG

Pharmaceutical form: tablet Route of administration: oral

Also known as: ZYPREXA

Cohort 1

Oral Olanzapine 15mg/day DRUG

Pharmaceutical form: tablet Route of administration: oral

Also known as: ZYPREXA

Cohort 2

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Body weight \>50 kg and body mass index (BMI) between 18.5 to 38.0 kg/m2, inclusive, at the time of screening.
• A current confirmed diagnosis of schizophrenia according to an evaluation by the investigator, using the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
• Are clinically stable, on oral olanzapine (i.e., dose has not changed in the last 4 weeks), and not currently on other antipsychotic treatment at the time of screening.
• No hospitalization for worsening of schizophrenic symptoms and no significant exacerbation of schizophrenic symptoms, as judged by the investigator, within the 3 months prior to screening.
• Female participants must have a negative serum pregnancy test at screening, are sterile or postmenopausal, and not planning pregnancy within the study period and for an additional 6 months after last dose administration.
• Male participants must be surgically sterile, or, if capable of producing offspring, has exclusively same-sex partners or is currently using an approved method of birth control.
• Agree to maintain current smoking or nonsmoking status at the time informed consent is obtained and throughout the study until completion of the end of study (EOS)/early termination (ET) visit.
• Have no ongoing or expected significant life events (such as pending loss of housing, marital status change, long travel abroad, surgery, etc.) that could affect study outcomes expected throughout the period of study participation.
• NOTE: Additional criteria apply, please contact the investigator for more information.

You may not qualify if:

• Presence or have a history of clinically significant diseases of the renal, hepatic, gastrointestinal, cardiovascular, musculoskeletal system or presence or history of clinically significant immunological, endocrine, metabolic, neurological, or psychiatric disorder(s) (other than schizophrenia), or a history of any illness that, in the opinion of the principal investigator, might pose additional risk to the participant by participation in the study or confound the results of the study
• Major trauma or surgery in the 2 months before screening or at any time between screening and the first dose of the investigational medicinal product (IMP), surgery scheduled during the study or follow-up period, or open biopsy within 4 months prior to screening
• History of malignancy or treatment of malignancy in the last 5 years, excluding resected basal cell or squamous cell carcinoma of the skin.
• NOTE: Additional criteria apply, please contact the investigator for more information.

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D LLC: lead

Study Sites (6)

Teva Investigational Site 88049

Beijing, 100088, China

Location

Teva Investigational Site 88048

Beijing, 100191, China

Location

Teva Investigational Site 88047

Guangzhou, 510370, China

Location

Teva Investigational Site 88046

Shanghai, 200030, China

Location

Teva Investigational Site 88050

Wuhan, 430022, China

Location

Teva Investigational Site 88056

Xi'an, 710061, China

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Olanzapine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products R&D LLC

USMedInfo@tevapharm.com

888-483-8279

Study Officials

• Teva Medical Expert, MD

  Teva Branded Pharmaceutical Products R&D LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 12, 2024
• Study Start: March 28, 2024
• Primary Completion: June 12, 2025
• Study Completion: June 12, 2025
• Last Updated: June 30, 2026
• Results First Posted: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

CN (6)