Healthy VolunteerPhase 1NCT04461483
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dose and Multiple Doses With Titration of TAK-935 in Healthy Japanese Participants
A Phase 1 study testing TAK-935 in people with Healthy Volunteer, run by Takeda at 1 site in Japan.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TAK-935 with single ascending doses (Part 1) and multiple doses with titration (Part 2). Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- TAK-935
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteJapan
- Study dates
- 13 Aug 2020to 14 Nov 2020
- 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 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The participant must understand the study procedures and agree to participate by providing written informed consent.
- The participant must be willing and able to comply with all study procedures and restrictions.
- The participant must be a Japanese healthy adult male or female, aged 20 to 55 years, inclusive, at the time of informed consent.
- The participant must have a body mass index (BMI) >=18.5 and =<25.0 kg/m^2 at the Screening Visit.
- The participant must be a current nonsmoker who has not used tobacco- or nicotine-containing products (eg, nicotine patch) for at least 6 months prior to the first dose of study drug or first invasive procedure.
- The participant must be judged to be in good health by the investigator, based on clinical evaluations including laboratory safety tests, medical history, physical examination, 12-lead electrocardiogram, and vital sign measurements performed at the Screening Visit and prior to the first dose of study drug.
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- The participant must meet the following birth control requirements:
- Is a male participant who is sterile or agrees to use an appropriate method of contraception, including a condom with spermicidal cream or jelly, from the first dose of study drug until 90 days after the last dose of study drug. No restrictions are required for a vasectomized male participant provided the participant is at least 1-year postbilateral vasectomy procedure prior to the first dose of study drug. A male participant whose vasectomy procedure was performed less than 1 year prior to the first dose of study drug must follow the same restrictions as a nonvasectomized man. Appropriate documentation of surgical procedure should be provided.
- Is a male participant who agrees to not donate sperm from the first dose of study drug until 90 days after the last dose of study drug.
- Is a female participant of nonchildbearing potential, defined by at least 1 of the following criteria:
- Postmenopausal (defined as 12 months of spontaneous amenorrhea in females aged >45 years or >=6 months of spontaneous amenorrhea in females aged >45 years with serum follicle-stimulating hormone [FSH] levels >40 mIU/mL). Appropriate documentation of follicle-stimulating hormone levels should be required.
- Hysterectomy and/or bilateral oophorectomy with appropriate documentation of surgical procedure.
- Had a tubal ligation with appropriate documentation of surgical procedure.
- Congenital conditions such as uterine aplasia etc.
Who cannot join
- Has a history of clinically significant endocrine, gastrointestinal (including motility disorder and intestinal obstruction), cardiovascular (including arrhythmia), hematological, hepatic, immunological, renal, respiratory, genitourinary, major neurological (including stroke, epileptic seizure), or degenerative ophthalmological abnormalities or diseases
- Has participated in another investigational trial within 4 weeks or 5 half-lives (whichever is longer) before the pretrial visit (Screening). The 4-week or 5 half-lives window will be derived from the date of the last trial procedure and/or AE related to the trial procedure in the previous trial to the pretrial/Screening Visit of the current trial.
- Is an employee or immediate family member (eg, spouse, parent, child, sibling) of the sponsor.
- Has a history of cancer (malignancy).
- Has any lifetime history of a suicide attempt, or have suicidal ideation or, any suicidal behavior within 12 months, or who are at significant risk to commit suicide, as judged by the investigator using the Columbia Suicide Severity Rating Scale (C-SSRS) or is clinically judged by the investigator to be at risk for suicide.
- Has a history of significant multiple and/or severe allergies (eg, food, drug, latex allergy) or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food.
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- Has a positive alcohol or drug screen.
- Had major surgery, donated or lost whole blood prior to the start of study drug administration as any of below:
- For both male and female participants, >=200 mL within 4 weeks (28 days) For male participants, >=400 mL within 12 weeks (84 days), >=800 mL in total within 52 weeks (364 days) For female participants, >=400 mL within 16 weeks (112 days). >=400 mL in total within 52 weeks (364 days)
- Had gastrointestinal surgery that could impact the absorption of study drug.
- Has a history of a major psychiatric disorder as diagnosed utilizing Diagnostic and Statistical Manual of Mental Disorders, 5th Edition criteria.
- Has a known hypersensitivity to any component of the formulation of TAK-935 or related compounds.
- Is unable to refrain from or anticipates the use of any medication, including prescription and nonprescription drugs or herbal remedies, beginning approximately 7 days before administration of the initial dose of study drug, throughout the trial (including washout intervals between trial periods), until the Follow-up Visit.
- Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the Screening visit or is unwilling to agree to abstain from alcohol and drugs throughout the study.
- Consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day.
- Has a substance abuse disorder.
- Has a QTcF >450 msec confirmed with one repeat testing, at the Screening Visit.
- Had abnormal Screening or Day -1 laboratory values that suggested a clinically significant underlying disease or participant with the following laboratory abnormalities: ALT and/or AST >1.5 time ULN.
- Has tested positive for hepatitis B virus surface antigen (HBsAg), hepatitis C virus (HCV) antibody, HIV antibody/antigen, or serologic reactions for syphilis at Screening.
- In the opinion of the investigator, is unlikely to comply with the protocol or is unsuitable for any other reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dose and Multiple Doses With Titration of TAK-935 in Healthy Japanese Subjects
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TAK-935 with single ascending doses (Part 1) and multiple doses with titration (Part 2).
Read the detailed description
The drug being tested in this study is called TAK-935 tablet. TAK-935 tablet is being tested in Japanese healthy adult men. This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TAK-935 with single ascending doses (Part 1) and multiple doses with titration (Part 2).
The study will enroll up to 33 participants in total (Part 1 + 2). In Part 1, participants will be randomly assigned (by chance, like flipping a coin) to one of these treatment cohorts/groups;
- Cohort 1: Single dose of TAK-935 at 200 mg or placebo (fasted)
- Cohort 2: Single dose of TAK-935 at 600 mg or placebo (fasted)
- Cohort 3: Single dose of TAK-935 at 1200 mg or placebo (fasted)
In Part 2, participants will be randomly assigned to one of these treatment groups;
- Cohort 4: Multiple doses with titration of TAK-935 or placebo at 100 mg twice daily (BID) from Day 1 to Day 7, 200 mg BID from Day 8 to Day 14 and 300 mg BID from Day 15 to Day 21 (fasted).
This single-center trial will be conducted in Japan. The overall time to participate in this study is approximately 36 days for Part 1 and 63 days for Part 2. Participants will be hospitalized for 5 days in Part 1 and 26 days in Part 2.
- Conditions
- Healthy Volunteer
- Being tested
- TAK-935, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-935Drug
TAK-935 Tablets
PlaceboDrug
TAK-935 placebo-matching tablets
| Study group | Role | What they receive |
|---|---|---|
| Part 1, Cohort 1; TAK-935 200 mg | Experimental | Part 1, Cohort 1; TAK-935 200 mg, tablets, orally once on Days 1 in fasted state. Receives: Drug: TAK-935 |
| Part 1, Cohort 2; TAK-935 600 mg | Experimental | Part 1, Cohort 2; TAK-935 600 mg, tablets, orally once on Days 1 in fasted state. Receives: Drug: TAK-935 |
| Part 1, Cohort 3; TAK-935 1200 mg | Experimental | Part 1, Cohort 3; TAK-935 1200 mg, tablets, orally once on Days 1 in fasted state. Receives: Drug: TAK-935 |
| Part 1, Cohort 1-3; Placebo | Placebo comparator | Part 1, Cohort 1-3; TAK-935 placebo-matching tablets, orally once on Days 1 in fasted state. Receives: Drug: Placebo |
| Part 2, Cohort 4: TAK-935 100 mg | Experimental | Part 2, Cohort 4: TAK-935 100 mg, tablets, orally twice on Days 1-7 in fasted state with multiple doses with titration. Receives: Drug: TAK-935 |
| Part 2, Cohort 4: TAK-935 200 mg | Experimental | Part 2, Cohort 4: TAK-935 200 mg, tablets, orally twice on Days 8-14 in fasted state with multiple doses with titration. Receives: Drug: TAK-935 |
| Part 2, Cohort 4: TAK-935 300 mg | Experimental | Part 2, Cohort 4: TAK-935 300 mg, tablets, orally twice on Days 15-21 in fasted state with multiple doses with titration. Receives: Drug: TAK-935 |
| Part 2, Cohort 4: Placebo | Placebo comparator | Part 2, Cohort 4: TAK-935 placebo-matching tablets, orally twice on Days 1-21 in fasted state. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parts 1 and 2: Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
Measured: Part 1: Baseline up to Day 8; Part 2: Baseline up to Day 35
Secondary outcomes (6)
Part 1, Cmax: Maximum Observed Plasma Concentration for TAK-935
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Part 2, Cmax: Maximum Observed Plasma Concentration for TAK-935
Measured: Days 7, 14, and 21 pre-dose and at multiple time points (up to 12 hours) post-dose
Part 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-935
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Part 1, AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Time of Infinity for TAK-935
Measured: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Part 1, AUC(0-24): Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours Post-dose for TAK-935
Measured: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose
Part 2, AUCtau,ss: Area Under the Plasma Concentration-time Curve During the Dosing Interval at Steady State for TAK-935
Measured: Days 7, 14, and 21 pre-dose and at multiple time points (up to 12 hours) post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start13 Aug 2020
- Primary completion14 Nov 2020
- Study completion14 Nov 2020
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 Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by TakedaThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda (Note: This product was divested to Mistrau Bio, Inc. in 2026)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04461483
- Sponsor's protocol ID
- TAK-935-1004
- Other IDs
- U1111-1252-8555, JapicCTI-205349
- Status last verified
- Aug 2026
- First submitted
- 3 Jul 2020
- Last updated
- 16 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending Dose and Multiple Doses With Titration of TAK-935 in Healthy Japanese Subjects
- ClinicalTrials.gov ID
- NCT04461483
- Acronym / sponsor ID
- TAK-935-1004
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 13 Aug 2020 (actual)
- Primary completion
- 14 Nov 2020 (actual)
- Study completion
- 14 Nov 2020 (actual)
- First posted
- 8 Jul 2020 (actual)
- Results
- Posted 11 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TAK-935 with single ascending doses (Part 1) and multiple doses with titration (Part 2).
Detailed description
The drug being tested in this study is called TAK-935 tablet. TAK-935 tablet is being tested in Japanese healthy adult men. This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TAK-935 with single ascending doses (Part 1) and multiple doses with titration (Part 2).
The study will enroll up to 33 participants in total (Part 1 + 2). In Part 1, participants will be randomly assigned (by chance, like flipping a coin) to one of these treatment cohorts/groups;
- Cohort 1: Single dose of TAK-935 at 200 mg or placebo (fasted)
- Cohort 2: Single dose of TAK-935 at 600 mg or placebo (fasted)
- Cohort 3: Single dose of TAK-935 at 1200 mg or placebo (fasted)
In Part 2, participants will be randomly assigned to one of these treatment groups;
- Cohort 4: Multiple doses with titration of TAK-935 or placebo at 100 mg twice daily (BID) from Day 1 to Day 7, 200 mg BID from Day 8 to Day 14 and 300 mg BID from Day 15 to Day 21 (fasted).
This single-center trial will be conducted in Japan. The overall time to participate in this study is approximately 36 days for Part 1 and 63 days for Part 2. Participants will be hospitalized for 5 days in Part 1 and 26 days in Part 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Part 1, Cohort 1; TAK-935 200 mg | Experimental | Drug: TAK-935Part 1, Cohort 1; TAK-935 200 mg, tablets, orally once on Days 1 in fasted state. |
| Part 1, Cohort 2; TAK-935 600 mg | Experimental | Drug: TAK-935Part 1, Cohort 2; TAK-935 600 mg, tablets, orally once on Days 1 in fasted state. |
| Part 1, Cohort 3; TAK-935 1200 mg | Experimental | Drug: TAK-935Part 1, Cohort 3; TAK-935 1200 mg, tablets, orally once on Days 1 in fasted state. |
| Part 1, Cohort 1-3; Placebo | Placebo comparator | Drug: PlaceboPart 1, Cohort 1-3; TAK-935 placebo-matching tablets, orally once on Days 1 in fasted state. |
| Part 2, Cohort 4: TAK-935 100 mg | Experimental | Drug: TAK-935Part 2, Cohort 4: TAK-935 100 mg, tablets, orally twice on Days 1-7 in fasted state with multiple doses with titration. |
| Part 2, Cohort 4: TAK-935 200 mg | Experimental | Drug: TAK-935Part 2, Cohort 4: TAK-935 200 mg, tablets, orally twice on Days 8-14 in fasted state with multiple doses with titration. |
| Part 2, Cohort 4: TAK-935 300 mg | Experimental | Drug: TAK-935Part 2, Cohort 4: TAK-935 300 mg, tablets, orally twice on Days 15-21 in fasted state with multiple doses with titration. |
| Part 2, Cohort 4: Placebo | Placebo comparator | Drug: PlaceboPart 2, Cohort 4: TAK-935 placebo-matching tablets, orally twice on Days 1-21 in fasted state. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- The participant must understand the study procedures and agree to participate by providing written informed consent.
- The participant must be willing and able to comply with all study procedures and restrictions.
- The participant must be a Japanese healthy adult male or female, aged 20 to 55 years, inclusive, at the time of informed consent.
- The participant must have a body mass index (BMI) >=18.5 and =<25.0 kg/m^2 at the Screening Visit.
- The participant must be a current nonsmoker who has not used tobacco- or nicotine-containing products (eg, nicotine patch) for at least 6 months prior to the first dose of study drug or first invasive procedure.
Key exclusion criteria (20 listed)
- Has a history of clinically significant endocrine, gastrointestinal (including motility disorder and intestinal obstruction), cardiovascular (including arrhythmia), hematological, hepatic, immunological, renal, respiratory, genitourinary, major neurological (including stroke, epileptic seizure), or degenerative ophthalmological abnormalities or diseases
- Has participated in another investigational trial within 4 weeks or 5 half-lives (whichever is longer) before the pretrial visit (Screening). The 4-week or 5 half-lives window will be derived from the date of the last trial procedure and/or AE related to the trial procedure in the previous trial to the pretrial/Screening Visit of the current trial.
- Is an employee or immediate family member (eg, spouse, parent, child, sibling) of the sponsor.
- Has a history of cancer (malignancy).
- Has any lifetime history of a suicide attempt, or have suicidal ideation or, any suicidal behavior within 12 months, or who are at significant risk to commit suicide, as judged by the investigator using the Columbia Suicide Severity Rating Scale (C-SSRS) or is clinically judged by the investigator to be at risk for suicide.
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 |
|---|---|---|
| TAK-935TAK-935 Tablets | Drug | Part 1, Cohort 1; TAK-935 200 mg, Part 1, Cohort 2; TAK-935 600 mg, Part 1, Cohort 3; TAK-935 1200 mg, Part 2, Cohort 4: TAK-935 100 mg, Part 2, Cohort 4: TAK-935 200 mg, Part 2, Cohort 4: TAK-935 300 mg |
| PlaceboTAK-935 placebo-matching tablets | Drug | Part 1, Cohort 1-3; Placebo, Part 2, Cohort 4: Placebo |
Primary outcome
Parts 1 and 2: Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
Time frame: Part 1: Baseline up to Day 8; Part 2: Baseline up to Day 35
6 secondary outcomes
Part 1, Cmax: Maximum Observed Plasma Concentration for TAK-935
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Part 2, Cmax: Maximum Observed Plasma Concentration for TAK-935
Time frame: Days 7, 14, and 21 pre-dose and at multiple time points (up to 12 hours) post-dose
Part 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-935
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Part 1, AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Time of Infinity for TAK-935
Time frame: Day 1 pre-dose and at multiple time points (up to 48 hours) post-dose
Part 1, AUC(0-24): Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours Post-dose for TAK-935
Time frame: Day 1 pre-dose and at multiple time points (up to 24 hours) post-dose
Part 2, AUCtau,ss: Area Under the Plasma Concentration-time Curve During the Dosing Interval at Steady State for TAK-935
Time frame: Days 7, 14, and 21 pre-dose and at multiple time points (up to 12 hours) post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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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.
Study Director study director
Takeda (Note: This product was divested to Mistrau Bio, Inc. in 2026)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TAK-935 in people with Healthy Volunteer, run by Takeda at 1 site in Japan.
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 14 inclusion and 20 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 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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. Some participants in this study may receive a placebo. 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 11 Jan 2022). 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?
Parts 1 and 2: Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) (time frame: Part 1: Baseline up to Day 8; Part 2: Baseline up to Day 35). 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 16 Sep 2026.