New shot could simplify schizophrenia treatment
NCT ID NCT06253546
First seen Jun 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time
Summary
This phase 1 trial tests a single injection of TV-44749, an extended-release form of olanzapine, in Chinese adults with stable schizophrenia. The study aims to check safety, tolerability, and how the drug moves through the body. Participants receive one of three doses of the injection or continue oral olanzapine for comparison.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TV-44749 (extended-release injectable olanzapine)
- What this could lead to
- If successful, this could provide a longer-lasting treatment option for schizophrenia, potentially reducing the need for daily pills.
- What could go wrong
- This is an early phase 1 trial with only 24 participants, so safety and effectiveness are not yet established. Side effects may occur, and results may not apply to broader populations.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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24 people
The number who actually took part.
- Started
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Mar 2024
- Finished
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Jun 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 64 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Teva Investigational Site 88046
Shanghai, 200030, China
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Teva Investigational Site 88047
Guangzhou, 510370, China
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Teva Investigational Site 88048
Beijing, 100191, China
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Teva Investigational Site 88049
Beijing, 100088, China
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Teva Investigational Site 88050
Wuhan, 430022, China
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Teva Investigational Site 88056
Xi'an, 710061, China
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Other studies related to the condition(s) this trial covers.
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