SchizophreniaPhase 1NCT06253546
Safety, Tolerability, and Pharmacokinetic Study of TV-44749 in Chinese Patients With Schizophrenia
A Phase 1 study testing TV-44749 318mg, Oral Olanzapine 10mg/day and TV-44749 425mg in people with Schizophrenia, run by Teva Branded Pharmaceutical Products R&D LLC at 6 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- TV-44749 318mg, Oral Olanzapine 10mg/day and TV-44749 425mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 6 sitesChina
- Study dates
- 28 Mar 2024to 12 Jun 2025
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Teva Investigational Site 88049
Beijing, 100088
Teva Investigational Site 88048
Beijing, 100191
Teva Investigational Site 88047
Guangzhou, 510370
Teva Investigational Site 88046
Shanghai, 200030
Teva Investigational Site 88050
Wuhan, 430022
Teva Investigational Site 88056
Xi'an, 710061
About this 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
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.
Read the detailed description
The total study duration for participants is planned to be approximately 13 weeks, including 40 days of screening, 1-week oral olanzapine treatment, a 1-week washout period, 4-week TV-44749 treatment, and 2-week follow-up period after the last dosing interval.
- Conditions
- Schizophrenia
- Being tested
- TV-44749 318mg, Oral Olanzapine 10mg/day, TV-44749 425mg, Oral Olanzapine 15mg/day, TV-44749 531mg
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TV-44749 318mgDrug
Pharmaceutical form:
extended-release injectable suspension
Route of administration: subcutaneous injection
Oral Olanzapine 10mg/dayDrug
Also called ZYPREXA
Pharmaceutical form:
tablet
Route of administration:
oral
TV-44749 425mgDrug
Pharmaceutical form: extended-release injectable suspension
Route of administration: subcutaneous injection
Oral Olanzapine 15mg/dayDrug
Also called ZYPREXA
Pharmaceutical form: tablet
Route of administration: oral
TV-44749 531mgDrug
Pharmaceutical form: extended-release injectable suspension
Route of administration: subcutaneous injection
Oral Olanzapine 20mg/dayDrug
Also called ZYPREXA
Pharmaceutical form: tablet
Route of administration: oral
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Period 1: Participants will receive oral olanzapine daily
Period 2: Participants will receive subcutaneous (sc) injection of TV-44749 Receives: 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 Receives: 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 Receives: Drug: TV-44749 531mg; Drug: Oral Olanzapine 20mg/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Day 1 Up to Day 43
Secondary outcomes (11)
Period 2: Maximum Observed Plasma Drug Concentration (Cmax) of TV-44749
Measured: 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
Measured: 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)
Measured: Day 1 Up to Day 43
Period 2: Time to Maximum Observed Concentration (Tmax) of TV-44749
Measured: Day 1 Up to Day 43
Period 2: Apparent Elimination Half-Life (t½) of TV-44749
Measured: Day 1 Up to Day 43
Period 1: Maximum Observed Plasma Drug Concentration at Steady State (Cmax,ss[Oral Olanzapine])
Measured: Day -8
Period 1: AUC of Oral Olanzapine From Time 0 to the End of the Dosing Interval (24 Hour) at Steady State (AUC0-tau,ss[Oral Olanzapine])
Measured: Day -8
Period 1: Calculated AUC of Oral Olanzapine at Steady State Extrapolated Over 28 Days (AUC0-tau,ss[Oral Olanzapine] * 28)
The steady-state AUC of oral olanzapine over a 28-day dosing interval was calculated by extrapolating the 24-hour AUC obtained following administration of the seventh oral dose (Day -8) to a 28-day period (AUC0-tau,ss[oral olanzapine] * 28).
Measured: Day -8 up to Day 20
Period 1: Time to Maximum Concentration of Oral Olanzapine at Steady State (Tmax,ss[Oral Olanzapine])
Measured: Day -8
Period 1: Number of Participants With TEAEs
An 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 SAEs, regardless of causality is located in the Reported AE section.
Measured: Day -14 up to Day -8
Period 1: 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-SAEs and all serious AEs, regardless of causality is located in the Reported AE section.
Measured: Day -14 up to Day -8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start28 Mar 2024
- Primary completion12 Jun 2025
- Study completion12 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Teva Branded Pharmaceutical Products R&D LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Teva Medical Expert, MD, Study director, Teva Branded Pharmaceutical Products R&D LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06253546
- Sponsor's protocol ID
- TV44749-PK-10188
- Status last verified
- Jun 2026
- First submitted
- 2 Feb 2024
- Last updated
- 30 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be assessed for scientific merit, product approval status, and conflicts of interest. If the request is approved, patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06253546
- Acronym / sponsor ID
- TV44749-PK-10188
- Conditions
- Schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D LLCIndustry (pharma, biotech, devices)
- Study start
- 28 Mar 2024 (actual)
- Primary completion
- 12 Jun 2025 (actual)
- Study completion
- 12 Jun 2025 (actual)
- First posted
- 12 Feb 2024 (actual)
- Results
- Posted 30 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The total study duration for participants is planned to be approximately 13 weeks, including 40 days of screening, 1-week oral olanzapine treatment, a 1-week washout period, 4-week TV-44749 treatment, and 2-week follow-up period after the last dosing interval.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: TV-44749 318mg, Drug: Oral Olanzapine 10mg/dayPeriod 1: Participants will receive oral olanzapine daily Period 2: Participants will receive subcutaneous (sc) injection of TV-44749 |
| Cohort 2 | Experimental | Drug: TV-44749 425mg, Drug: Oral Olanzapine 15mg/dayPeriod 1: Participants will receive oral olanzapine daily Period 2: Participants will receive sc injection of TV-44749 |
| Cohort 3 | Experimental | Drug: TV-44749 531mg, Drug: Oral Olanzapine 20mg/dayPeriod 1: Participants will receive oral olanzapine daily Period 2: Participants will receive sc injection of TV-44749 |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TV-44749 318mgPharmaceutical form: extended-release injectable suspension Route of administration: subcutaneous injection | Drug | Cohort 1 |
| Oral Olanzapine 10mg/dayAlso: ZYPREXAPharmaceutical form: tablet Route of administration: oral | Drug | Cohort 1 |
| TV-44749 425mgPharmaceutical form: extended-release injectable suspension Route of administration: subcutaneous injection | Drug | Cohort 2 |
| Oral Olanzapine 15mg/dayAlso: ZYPREXAPharmaceutical form: tablet Route of administration: oral | Drug | Cohort 2 |
| TV-44749 531mgPharmaceutical form: extended-release injectable suspension Route of administration: subcutaneous injection | Drug | Cohort 3 |
| Oral Olanzapine 20mg/dayAlso: ZYPREXAPharmaceutical form: tablet Route of administration: oral | Drug | Cohort 3 |
Primary outcome
Period 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Day 1 Up to Day 43
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.
Period 2: Number of Participants With Treatment Emergent SAEs
Time frame: Day 1 Up to Day 43
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.
Period 2: Number of Participants With Injection Site AEs
Time frame: Day 1 Up to Day 43
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.
11 secondary outcomes
Period 2: Maximum Observed Plasma Drug Concentration (Cmax) of TV-44749
Time frame: 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
Time frame: 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)
Time frame: Day 1 Up to Day 43
Period 2: Time to Maximum Observed Concentration (Tmax) of TV-44749
Time frame: Day 1 Up to Day 43
Period 2: Apparent Elimination Half-Life (t½) of TV-44749
Time frame: Day 1 Up to Day 43
Period 1: Maximum Observed Plasma Drug Concentration at Steady State (Cmax,ss[Oral Olanzapine])
Time frame: Day -8
Period 1: AUC of Oral Olanzapine From Time 0 to the End of the Dosing Interval (24 Hour) at Steady State (AUC0-tau,ss[Oral Olanzapine])
Time frame: Day -8
Period 1: Calculated AUC of Oral Olanzapine at Steady State Extrapolated Over 28 Days (AUC0-tau,ss[Oral Olanzapine] * 28)
Time frame: Day -8 up to Day 20
Period 1: Time to Maximum Concentration of Oral Olanzapine at Steady State (Tmax,ss[Oral Olanzapine])
Time frame: Day -8
Period 1: Number of Participants With TEAEs
Time frame: Day -14 up to Day -8
Period 1: Number of Participants With Treatment Emergent SAEs
Time frame: Day -14 up to Day -8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be assessed for scientific merit, product approval status, and conflicts of interest. If the request is approved, patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teva Medical Expert, MD study director
Teva Branded Pharmaceutical Products R&D LLC
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TV-44749 318mg, Oral Olanzapine 10mg/day and TV-44749 425mg in people with Schizophrenia, run by Teva Branded Pharmaceutical Products R&D LLC at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Period 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) (time frame: Day 1 Up to Day 43). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.