SchizophreniaPhase 3Starlyng-2NCT06878833
A Study to Evaluate the Safety and Tolerability of Long-Acting Oral Risperidone (LYN-005) in Participants With Schizophrenia or Schizoaffective Disorder
A Phase 3 study testing LYN-005 (risperidone) and IR Risperidone in people with Schizophrenia and Schizoaffective Disorder, run by Lyndra Inc..
Trial summary
Lyndra Therapeutics, Inc., is developing a long-acting oral (LAO) treatment of risperidone (LYN-005) in a capsule dosage form (LYNX® drug delivery platform). The intent of LYN-005 is to reduce the dosing frequency of orally-administered risperidone to once weekly or less and, thereby improve treatment adherence and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- LYN-005 (risperidone) and IR Risperidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 18 Apr 2025to 31 Dec 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged ≥18 and ≤65 years.
- Current diagnosis of schizophrenia or schizoaffective disorder according to Diagnostic and Statistical Manual of Mental Disorders version 5 (DSM-5) criteria as confirmed by the Mini International Neuropsychiatric Interview version 7.0.2 (MINI 7.0.2).
- Psychiatric criteria:
- Duration of diagnosis of schizophrenia or schizoaffective disorder for ≥2 years.
- Outpatient; not hospitalized for worsening of schizophrenia within the last 6 months (partial hospitalization for social management within this time period is acceptable).
- Medically stable over the last month and psychiatrically stable without significant symptom exacerbation over the last 3 months.
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- Stabilized on a therapeutic dose of an oral antipsychotic drug for a minimum of 6 weeks at the time of Screening.
- On a stable dosage of all permitted non-antipsychotic medications (except for medication to be used on an as-needed basis) for at least 1 month before the Screening visit and for the duration of the study.
- Clinical Global Impression-Severity (CGI-S) score of ≤4 (moderately ill) at Screening and Day -7.
- Positive and Negative Syndrome Scale (PANSS) score of ≤80 points at Screening.
- Body mass index (BMI) of ≥18 kg/m2 and ≤38 kg/m2.
- Able to read and understand study procedures and provide written informed consent before the initiation of any protocol-specific procedures.
- Willing to comply with all protocol-specified procedures and availability for the duration of the study.
Who cannot join
- Participants with known clinically significant esophageal or GI disease, including but not limited to:
- Known strictures such as esophageal web, pyloric stenosis, or small intestinal stricture, or participants with high risk of stricture, e.g., Crohn's disease.
- Prior varices or small or large bowel obstructions.
- Prior abdominal or upper gastrointestinal surgery including gastric bypass or removal of a significant portion of the gastrointestinal (GI) tract that may impose a high risk of strictures (prior uncomplicated laparoscopic procedures including appendectomy or colectomy are permitted).
- History of diarrhea or constipation within 3 months of Screening that in the opinion of the investigator would be considered clinically significant.
- Multiple episodes of moderate or severe abdominal pain within 3 months of Screening.
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- History of moderate to severe Acid Reflux Disease or a score of ≥2 on the Acid Reflux Severity Scale (ARSS) [2], indicating moderate to severe symptoms.
- PILL-5 questionnaire score of 5 or greater.
- Any clinically significant medical, surgical or psychiatric condition that in the opinion of the investigator would exclude them from the study, including:
- Presence of an uncontrolled, unstable, clinically significant medical condition that could put the participant at risk because of participation in the study, interfere with the participant's ability to participate in the study or influence the interpretation of safety or pharmacokinetic (PK) evaluations.
- History of a major cardiovascular event (myocardial infarction, cardiac surgery or revascularization, unstable angina, stroke, or transient ischemic attack) or a hospitalization for heart failure within 6 months of Screening.
- Any clinically significant illness, medical or surgical procedure or trauma within 4 weeks of Screening.
- Known immunocompromised status, including individuals who have undergone organ transplantation, on immunosuppression for an immune mediated disease, or are positive for human immunodeficiency virus (HIV).
- Positive test for active hepatitis B or C at Screening. Participants with successfully treated hepatitis B infection which has been resolved for greater than 1 year or successfully treated hepatitis C infection will not be excluded.
- Have donated more than 250 mL of blood within 30 days of Screening.
- Have difficulties with venipuncture/cannulation, including difficulty accessing veins for blood sampling and/or history of coagulopathy or endocarditis.
- Current DSM-5 diagnosis of major depressive episode, panic disorder, agoraphobia, social anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder, generalized anxiety disorder on the MINI 7.0.2 or in the judgment of the Investigator. (Note that individuals with depression secondary to schizoaffective disorder are eligible).
- Suicidal ideation associated with actual intent and a method or plan in the past 6 months, as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS; i.e., "Yes" answers on items 4 or 5) at Screening and Day -7or having made a suicide attempt within the last 2 years.
- Known or suspected (non-febrile) seizure disorder.
- History of neuroleptic malignant syndrome
- Current or history of clinically significant tardive dyskinesia.
- Known or suspected diagnosis of intellectual disability or organic brain disorder or other diagnosis that is primarily responsible for current symptoms and functional impairment.
- Medically non-adherent in the management of their schizophrenia/schizoaffective disorder.
- Use of the below medications/treatments in the 2 weeks before enrollment:
- Proton pump inhibitors or H2 blockers.
- Prokinetic agents.
- Medications that may interfere with the absorption, metabolism, or excretion of risperidone, e.g.: i. Drugs metabolized via Cytochrome P450 3A4 (CYP3A4) pathway, such as macrolide antibiotics and azole antifungals; ii. Moderate or strong CYP3A4 p-glycoprotein (P-gp) enzyme inducers and inhibitors (carbamazepine, phenytoin, rifampicin, phenobarbital, itraconazole, verapamil); iii. Moderate or strong Cytochrome P450 2D6 (CYP2D6) inhibitors (e.g., fluoxetine, fluoxetine combinations, paroxetine, or quinidine).
- Concomitant medications, natural remedies, supplements, or vitamins that are associated with changes to gastric motility or pH. Use of antacids is permissible, except within 2 hours of dosing with LYN-005.
- Use of more than one antidepressant for the treatment of depression; or if on just one, a change in dose within 6 weeks of Screening.
- Depot antipsychotic use within 6 months of Screening.
- Electroconvulsive therapy within 3 months of Screening.
- Participants with clinically significant abnormal safety (e.g. physical examination, vital sign) or safety laboratory assessments, specifically:
- Presence of a clinically significant abnormal laboratory result on blood or urine safety tests at Screening.
- Anemia (hemoglobin below lower limit of normal reference range) at Screening.
- Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≥3.0 × upper limit of normal (ULN), or total bilirubin ≥1.5 × ULN.
- Moderate or severe renal insufficiency at Screening (glomerular filtration rate <60 mL/min, as determined the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation).
- Heart rate of <50 beats per minute (bpm) at Screening.
- Systolic blood pressure <100 or ≥150 mmHg and/or diastolic blood pressure <60 mmHg or ≥100 mmHg, and/or orthostatic hypotension, at Screening.
- HbA1c ≥6.5% at Screening.
- Positive fecal occult blood test at Screening.
- Clinically significant prolactin elevation (≥200 ng/mL for females; ≥100 ng/mL for males).
- The following specified patterns of substance use at Screening:
- Fulfillment of the DSM-5 criteria for moderate or severe substance use disorder (excluding nicotine and caffeine) within 6 months of Screening.
- History of alcohol consumption exceeding moderate use; in males exceeding 21 units per week and in females exceeding 14 units per week (1 unit = 360 ml beer, 25 mL of 40% spirit or a 125 mL glass of wine) over the past month. Participants are not permitted to consume alcohol during the inpatient stay nor 12 hours before any clinic visit while outpatient.
- Positive ethanol breathalyzer.
- Positive urine drug screen for substances of abuse other than cannabis at screening or Day -7.
- Heavy nicotine use (consumption of >40 cigarettes or >36 mg of nicotine from other sources [e.g., vaping products] daily) or daily use of smokeless tobacco.
- Participants of reproductive potential who are (hetero) sexually active but unwilling to use acceptable means of contraception through the End-of-Study. For clarity, participants who are at least 1 year post-menopausal are not of reproductive potential. Acceptable means of contraception include:
- Participants who have been surgically sterilized.
- Females of reproductive potential: diaphragm, injectable, oral/patch contraceptives for a minimum of 6 weeks, contraceptive sponge, implant, or intrauterine device in use prior to enrollment.
- Males: condom in combination with any of the above means of contraception.
- All participants: abstinence may be an acceptable means of contraception as long as the individual consents to initiate immediate use of double barrier protection for the duration of the study should (hetero) sexual intercourse occur.
- Participants who are nursing or who have positive or indeterminate pregnancy tests at either Screening (serum test) or Day -7 (urine test).
- Participants with history of X-ray, computed tomography (CT) scan or angiogram of the abdomen within one year of Screening
- Use of any experimental agent within 1 month or 5 half-lives of Screening, whichever is longer.
- Employee or immediate family member of employees of the site, Sponsor, or study-related vendors.
- History of a serious allergic or hypersensitivity reaction to risperidone or LYN-005 excipients (refer to Investigator's Brochure). Previous use of LYN-005 alone, does not exclude participants.
- CYP2D6 poor or indeterminate metabolizer status based on genetic testing.
About this study
Official title: A Multidose, Randomized, Double-Blind Study to Evaluate the Safety and Tolerability of Long-Acting Oral Risperidone (LYN-005) in Participants With Schizophrenia or Schizoaffective Disorder
Lyndra Therapeutics, Inc., is developing a long-acting oral (LAO) treatment of risperidone (LYN-005) in a capsule dosage form (LYNX® drug delivery platform). The intent of LYN-005 is to reduce the dosing frequency of orally-administered risperidone to once weekly or less and, thereby improve treatment adherence and management of schizophrenia and schizoaffective disorder.
This study will evaluate the safety and tolerability of multiple administrations of LYN-005 at 3 dose levels.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- LYN-005 (risperidone), Placebo for LYN-005, IR Risperidone, Placebo for IR Risperidone
- Keywords
- Schizophrenia, Schizoaffective Disorder, Risperidone, LYN-005, long-acting oral (LAO) therapy
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LYN-005 (risperidone)Drug
long-acting oral (LAO) capsule
Placebo for LYN-005Drug
capsule
IR RisperidoneDrug
tablets
Placebo for IR RisperidoneDrug
tablets
| Study group | Role | What they receive |
|---|---|---|
| Open Label (OL) Cohort | Experimental | After a 7-day run-in period in which participants receive immediate release (IR) risperidone (2 mg/day, 4 mg/day, or 6 mg/day, based on prior antipsychotic drug dose) and a single dose of LYN-005-matched placebo, participants receive weekly doses of 15, 30, or 45 mg of LYN-005 for 7 weeks. Receives: Drug: LYN-005 (risperidone); Drug: Placebo for LYN-005; Drug: IR Risperidone |
| Double Blind (DB) Cohort: LYN-005 | Experimental | After a 7-day run-in period in which participants receive IR risperidone (2 mg/day, 4 mg/day, or 6 mg/day, based on prior antipsychotic drug dose) and a single dose of LYN-005-matched placebo, participants receive weekly doses of 15, 30, or 45 mg of LYN-005 and daily doses of IR risperidone-matched placebo for 26 weeks. Receives: Drug: LYN-005 (risperidone); Drug: Placebo for LYN-005; Drug: IR Risperidone; Drug: Placebo for IR Risperidone |
| Double Blind (DB) Cohort: IR Risperidone | Active comparator | After a 7-day run-in period in which participants receive IR risperidone (2 mg/day, 4 mg/day, or 6 mg/day, based on prior antipsychotic drug dose) and a single dose of LYN-005-matched placebo, participants receive daily doses of 2, 4, or 6 mg IR risperidone and weekly doses of LYN-005-matched placebo for 26 weeks. Receives: Drug: Placebo for LYN-005; Drug: IR Risperidone; Drug: Placebo for IR Risperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Measured: OL Cohort: Screening through Day 57; DB Cohort: Screening through Day 203
Secondary outcomes (4)
PK Evaluation: Minimum Observed Concentration (Cmin) of Active Moiety at Week 5 (OL Cohort only)
Measured: Week 5: postdose: 24 hours (±30 minutes), 48 hours (±30 minutes), 72 hours (±30 minutes), 96 hours (±30 minutes), 120 hours (±30 minutes),144 hours (±30 minutes), and 168 hours (up to 30 minutes before 168 hours)
PK Evaluation: Maximal Observed Concentration (Cmax) of Active Moiety at Week 5 (OL Cohort only)
Measured: Week 5: postdose: 24 hours (±30 minutes), 48 hours (±30 minutes), 72 hours (±30 minutes), 96 hours (±30 minutes), 120 hours (±30 minutes),144 hours (±30 minutes), and 168 hours (up to 30 minutes before 168 hours)
PK Evaluation: Average Concentration (Cavg) of Active Moiety at Week 5 (OL Cohort only)
Measured: Week 5: postdose: 24 hours (±30 minutes), 48 hours (±30 minutes), 72 hours (±30 minutes), 96 hours (±30 minutes), 120 hours (±30 minutes),144 hours (±30 minutes), and 168 hours (up to 30 minutes before 168 hours)
Change in Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) Over Time
Measured: OL Cohort: Baseline, Day 22 and 43; DB Cohort: Baseline, Days 22, 43, 92, 106, 134, 162, 183
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start18 Apr 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Why it stopped: Sponsor stopped operations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lyndra Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nayana Nagaraj, Study director, Lyndra Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06878833
- Sponsor's protocol ID
- LYN-005-C-302
- Acronym
- Starlyng-2
- Status last verified
- Apr 2025
- First submitted
- 25 Feb 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multidose, Randomized, Double-Blind Study to Evaluate the Safety and Tolerability of Long-Acting Oral Risperidone (LYN-005) in Participants With Schizophrenia or Schizoaffective Disorder
- ClinicalTrials.gov ID
- NCT06878833
- Acronym / sponsor ID
- Starlyng-2 / LYN-005-C-302
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- Schizophrenia, Schizoaffective Disorder, Risperidone, LYN-005, long-acting oral (LAO) therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor stopped operations
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Lyndra Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Apr 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lyndra Therapeutics, Inc., is developing a long-acting oral (LAO) treatment of risperidone (LYN-005) in a capsule dosage form (LYNX® drug delivery platform). The intent of LYN-005 is to reduce the dosing frequency of orally-administered risperidone to once weekly or less and, thereby improve treatment adherence and management of schizophrenia and schizoaffective disorder.
This study will evaluate the safety and tolerability of multiple administrations of LYN-005 at 3 dose levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Open Label (OL) Cohort | Experimental | Drug: LYN-005 (risperidone), Drug: Placebo for LYN-005, Drug: IR RisperidoneAfter a 7-day run-in period in which participants receive immediate release (IR) risperidone (2 mg/day, 4 mg/day, or 6 mg/day, based on prior antipsychotic drug dose) and a single dose of LYN-005-matched placebo, participants receive weekly doses of 15, 30, or 45 mg of LYN-005 for 7 weeks. |
| Double Blind (DB) Cohort: LYN-005 | Experimental | Drug: LYN-005 (risperidone), Drug: Placebo for LYN-005, Drug: IR Risperidone, Drug: Placebo for IR RisperidoneAfter a 7-day run-in period in which participants receive IR risperidone (2 mg/day, 4 mg/day, or 6 mg/day, based on prior antipsychotic drug dose) and a single dose of LYN-005-matched placebo, participants receive weekly doses of 15, 30, or 45 mg of LYN-005 and daily doses of IR risperidone-matched placebo for 26 weeks. |
| Double Blind (DB) Cohort: IR Risperidone | Active comparator | Drug: Placebo for LYN-005, Drug: IR Risperidone, Drug: Placebo for IR RisperidoneAfter a 7-day run-in period in which participants receive IR risperidone (2 mg/day, 4 mg/day, or 6 mg/day, based on prior antipsychotic drug dose) and a single dose of LYN-005-matched placebo, participants receive daily doses of 2, 4, or 6 mg IR risperidone and weekly doses of LYN-005-matched placebo for 26 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or female aged ≥18 and ≤65 years.
- Current diagnosis of schizophrenia or schizoaffective disorder according to Diagnostic and Statistical Manual of Mental Disorders version 5 (DSM-5) criteria as confirmed by the Mini International Neuropsychiatric Interview version 7.0.2 (MINI 7.0.2).
- Psychiatric criteria:
- Stabilized on a therapeutic dose of an oral antipsychotic drug for a minimum of 6 weeks at the time of Screening.
- On a stable dosage of all permitted non-antipsychotic medications (except for medication to be used on an as-needed basis) for at least 1 month before the Screening visit and for the duration of the study.
Key exclusion criteria (58 listed)
- Participants with known clinically significant esophageal or GI disease, including but not limited to:
- PILL-5 questionnaire score of 5 or greater.
- Any clinically significant medical, surgical or psychiatric condition that in the opinion of the investigator would exclude them from the study, including:
- Use of the below medications/treatments in the 2 weeks before enrollment:
- Participants with clinically significant abnormal safety (e.g. physical examination, vital sign) or safety laboratory assessments, specifically:
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 |
|---|---|---|
| LYN-005 (risperidone)long-acting oral (LAO) capsule | Drug | Double Blind (DB) Cohort: LYN-005, Open Label (OL) Cohort |
| Placebo for LYN-005capsule | Drug | Double Blind (DB) Cohort: IR Risperidone, Double Blind (DB) Cohort: LYN-005, Open Label (OL) Cohort |
| IR Risperidonetablets | Drug | Double Blind (DB) Cohort: IR Risperidone, Double Blind (DB) Cohort: LYN-005, Open Label (OL) Cohort |
| Placebo for IR Risperidonetablets | Drug | Double Blind (DB) Cohort: IR Risperidone, Double Blind (DB) Cohort: LYN-005 |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: OL Cohort: Screening through Day 57; DB Cohort: Screening through Day 203
4 secondary outcomes
PK Evaluation: Minimum Observed Concentration (Cmin) of Active Moiety at Week 5 (OL Cohort only)
Time frame: Week 5: postdose: 24 hours (±30 minutes), 48 hours (±30 minutes), 72 hours (±30 minutes), 96 hours (±30 minutes), 120 hours (±30 minutes),144 hours (±30 minutes), and 168 hours (up to 30 minutes before 168 hours)
PK Evaluation: Maximal Observed Concentration (Cmax) of Active Moiety at Week 5 (OL Cohort only)
Time frame: Week 5: postdose: 24 hours (±30 minutes), 48 hours (±30 minutes), 72 hours (±30 minutes), 96 hours (±30 minutes), 120 hours (±30 minutes),144 hours (±30 minutes), and 168 hours (up to 30 minutes before 168 hours)
PK Evaluation: Average Concentration (Cavg) of Active Moiety at Week 5 (OL Cohort only)
Time frame: Week 5: postdose: 24 hours (±30 minutes), 48 hours (±30 minutes), 72 hours (±30 minutes), 96 hours (±30 minutes), 120 hours (±30 minutes),144 hours (±30 minutes), and 168 hours (up to 30 minutes before 168 hours)
Change in Structured Clinical Interview for the Positive and Negative Syndrome Scale (SCI-PANSS) Over Time
Time frame: OL Cohort: Baseline, Day 22 and 43; DB Cohort: Baseline, Days 22, 43, 92, 106, 134, 162, 183
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Nayana Nagaraj study director
Lyndra Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LYN-005 (risperidone) and IR Risperidone in people with Schizophrenia and Schizoaffective Disorder, run by Lyndra Inc..
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 13 inclusion and 58 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: withdrawn, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: OL Cohort: Screening through Day 57; DB Cohort: Screening through Day 203). 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 8 Apr 2025.