Healthy VolunteersPhase 1NCT04082481
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of TAK-988 in Healthy Participants
A Phase 1 study testing TAK-988 in people with Healthy Volunteers, run by Takeda at 2 sites in United States.
Trial summary
The purpose of this study is to assess the safety and tolerability of TAK-988 following single and multiple oral doses in healthy non-Japanese and Japanese adult participants and healthy elderly (HE) participants. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- TAK-988
- 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
- 2 sitesUnited States
- Study dates
- 17 Nov 2021to 29 Apr 2022
- Phase
- Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be normotensive, with no history of hypertension or use of antihypertensive medication. Blood pressure (BP) must be less than (<) 140 millimeter of mercury (mmHg) (systolic) and <90 mmHg (diastolic).
- Healthy Adult and Elderly Participants (Parts A through D)
- Must have a body mass index (BMI) greater than or equal to (>=) 18.0 and less than or equal to (<=) 30.0 kilogram per square meter (kg/m^2) at the screening visit (non-Japanese only).
- Healthy Adult Participants (Parts A, B, and C)
- Must be aged 18 to 55 years, inclusive, at the screening visit.
- Must have a body weight >=50 kilogram (kg) at the screening visit.
Show all 15Show fewer
- HE Participants (Part D)
- Must be aged >=65 years, inclusive, at the time of informed consent.
- Must have a body weight >=40 kg at the screening visit.
- Healthy Japanese Adult Participants (Part E)
- Must be aged 18 to 55 years, inclusive, at the screening visit.
- Must have a BMI >=18.0 and <=26.0 kg/m^2 at the screening visit.
- Must have been born in Japan to a Japanese mother and father and have maternal and paternal Japanese grandparents.
- Must have not been away from Japan for more than 10 years at the screening visit.
- In the opinion of the investigator, must have a lifestyle that has not changed significantly since relocation from Japan.
Who cannot join
- Has a known hypersensitivity to any component of the formulation of TAK-988 or related compounds.
- Has a risk of suicide according to endorsement of Item 4 or 5 of the screening/baseline visit Columbia Suicide Severity Rating Scale (C-SSRS) or has made a suicide attempt in the previous 6 months.
- Has a lifetime history of major psychiatric disorder, such as bipolar disorder or schizophrenia. Participant who have history of major depressive disorder (MDD) may be included, but participants who have current active MDD or who have had active MDD in the past 6 months are excluded.
- Has a clinically significant history of head injury or head trauma.
- Has a history of cerebral ischemia, transient ischemic attack, intracranial aneurysm, or arteriovenous malformation.
- Screening electrocardiogram (ECG) reveals a QT interval with the Fridericia's correction method (QTcF) greater than (>) 450 millisecond (ms) (men) or >470 ms (women).
Show all 10Show fewer
- Has a resting heart rate outside of the range of 45 to 100 beats per minute, confirmed on repeat testing within a maximum of 30 minutes).
- Healthy Non-Japanese Adult Participants (Part C)
- Has undergone CSF collection within 30 days before check-in (Day -2).
- Has a known hypersensitivity to anesthesia or its derivatives used during CSF collection or to any medication used to prepare the area of lumbar puncture.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Parexel Internalional - Glendale
Glendale, California, 91206
PRA Health Sciences - Salt Lake City
Millcreek, Utah, 84124
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Rising Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-988 in Healthy Subjects
The purpose of this study is to assess the safety and tolerability of TAK-988 following single and multiple oral doses in healthy non-Japanese and Japanese adult participants and healthy elderly (HE) participants.
Read the detailed description
The drug being tested in this study is called TAK-988. TAK-988 is being tested to evaluate safety, tolerability, PK, and PD of single and multiple oral doses in healthy non-Japanese and Japanese adult participants and HE participants.
The study will enroll approximately 156 healthy participants. The study consists of 5 parts and up to 19 cohorts as mentioned below:
- TAK-988, Part A: Single-rising dose (SRD) design to assess the safety, tolerability, and PK of TAK-988 and effect of food on the PK of the TAK-988
- TAK-988, Part B: MRD design to assess the safety, tolerability, PK and PD of TAK-988
- TAK-988, Part C: MRD design to assess the safety, tolerability, PK and PD of TAK-988 and also central nervous system penetration relative to plasma concentrations of TAK-988
- TAK-988, Part D: MRD design to assess the safety, tolerability, PK and PD of TAK-988 for HE participants
- TAK-988, Part E: SRD and MRD design to assess the safety, tolerability, PK and PD of TAK-988 for Japanese origin participants
Participants in each cohort will be randomized to receive treatment with TAK-988 or matching placebo which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need).
This multi-center trial will be conducted in the United States. The overall duration of the study is approximately 10.5 months. Participants will make a final visit 7 days after receiving their last dose of study drug for a follow-up assessment.
- Conditions
- Healthy Volunteers
- Being tested
- TAK-988, TAK-988 Placebo
- Keywords
- Drug Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-988Drug
TAK-988 tablets.
TAK-988 PlaceboDrug
TAK-988 placebo-matching tablets.
| Study group | Role | What they receive |
|---|---|---|
| TAK-988: Part A | Experimental | TAK-988 tablet or TAK-988 placebo-matching tablet, orally, once on Day 1 to healthy non-Japanese participants. Sentinel dosing will be done in the first 2 cohorts of Part A (Cohorts A1 and A2 [fasted and fed dosing conditions]). Dose escalation in Cohorts A2 to A6 will be based on emerging safety/tolerability, PK, and PD data from previous cohorts. Receives: Drug: TAK-988; Drug: TAK-988 Placebo |
| TAK-988: Part B | Experimental | TAK-988 tablet or TAK-988 placebo-matching tablet, orally, twice daily (6-hour interval) from Day 1 to Day 14 to healthy non-Japanese participants. Dose escalation will be based on review of the emerging safety/tolerability, PK, and PD data from previous cohorts and Part A. Receives: Drug: TAK-988; Drug: TAK-988 Placebo |
| TAK-988: Part C | Experimental | TAK-988 tablet or TAK-988 placebo-matching tablet, orally, twice daily (6-hour interval) from Day 1 to Day 7 to healthy non-Japanese participants. Dose will be determined based on previous multiple-rising dose (MRD) cohorts. Receives: Drug: TAK-988; Drug: TAK-988 Placebo |
| TAK-988: Part D | Experimental | TAK-988 tablet or TAK-988 placebo-matching tablet, orally, twice daily (6-hour interval) from Day 1 to Day 14 to HE non-Japanese participants. Dose will be determined based on previous MRD cohorts. Receives: Drug: TAK-988; Drug: TAK-988 Placebo |
| TAK-988: Part E | Experimental | TAK-988 tablet or TAK-988 placebo-matching tablet, orally, once on Day 1, followed by a washout period of 2 days and twice daily (6- hour interval) on Day 3 and continue to Day 17 to healthy Japanese participants. Dose will be determined based on previous MRD cohorts. Receives: Drug: TAK-988; Drug: TAK-988 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs)
Measured: Baseline up to Day 26
Number of Participants With at Least one Markedly Abnormal Value (MAV) for Laboratory Values
Measured: Baseline up to Day 26
Number of Participants With at Least one MAV for Vital Signs
Measured: Baseline up to Day 26
Number of Participants With at Least one MAV for Electrocardiograms (ECGs)
Measured: Baseline up to Day 26
Secondary outcomes (9)
Cmax: Maximum Observed Plasma Concentration for TAK-988
Measured: Day 1 (Parts A-E), Day 7 (Part C), Day 14 (Parts B and D), Day 17 (Part E) pre-dose and at multiple time points (up to 72 hours) post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-988
Measured: Day 1 (Parts A-E), Day 7 (Part C), Day 14 (Parts B and D), Day 17 (Part E) pre-dose and at multiple time points (up to 72 hours) post-dose
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-988
Measured: Day 1 (Parts A-E) pre-dose and at multiple time points (up to 72 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-988
Measured: Day 1 (Parts A-E) pre-dose and at multiple time points (up to 72 hours) post-dose
T1/2z: Terminal Disposition Phase Half-life for TAK-988
Measured: Day 1 (Parts A-E) pre-dose and at multiple time points (up to 72 hours) post-dose
CLR: Renal Clearance for TAK-988
Measured: Day 1 (Parts A, B, D and E), Day 14 (Parts B and D), Day 17 (Part E) pre-dose and at multiple time points (up to 72 hours) post-dose
AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to tau over Dosing Interval for TAK-988
Measured: Day 7 (Part C), Day 14 (Parts B and D), Day 17 (Part E) pre-dose and at multiple time points (up to 72 hours) post-dose
Part C: Ratio of the Cerebrospinal Fluid (CSF) to Plasma AUC From Time 0 to 24 Hours for TAK-988
Measured: Day 7 (Part C) Pre-dose and at multiple time points (up to 24 hours) post-dose
Rac (AUC): Accumulation Ratio Based on AUCτ for TAK-988
Measured: Day 7 (Part C), Day 14 (Parts B and D), Day 17 (Part E) pre-dose and at multiple time points (up to 72 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 posted9 Sep 2019
- Study start17 Nov 2021 (estimated)
- Primary completion29 Apr 2022 (estimated)
- Study completion29 Apr 2022 (estimated)
Why it stopped: The study stopped early, before enrolling its first participant.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04082481
- Sponsor's protocol ID
- TAK-988-1001
- Other IDs
- U1111-1238-5474
- Status last verified
- Nov 2021
- First submitted
- 5 Sep 2019
- Last updated
- 26 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Rising Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-988 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04082481
- Acronym / sponsor ID
- TAK-988-1001
- Conditions
- Healthy Volunteers
- Keywords
- Drug Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study stopped early, before enrolling its first participant.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 17 Nov 2021 (estimated)
- Primary completion
- 29 Apr 2022 (estimated)
- Study completion
- 29 Apr 2022 (estimated)
- First posted
- 9 Sep 2019 (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.
The purpose of this study is to assess the safety and tolerability of TAK-988 following single and multiple oral doses in healthy non-Japanese and Japanese adult participants and healthy elderly (HE) participants.
Detailed description
The drug being tested in this study is called TAK-988. TAK-988 is being tested to evaluate safety, tolerability, PK, and PD of single and multiple oral doses in healthy non-Japanese and Japanese adult participants and HE participants.
The study will enroll approximately 156 healthy participants. The study consists of 5 parts and up to 19 cohorts as mentioned below:
- TAK-988, Part A: Single-rising dose (SRD) design to assess the safety, tolerability, and PK of TAK-988 and effect of food on the PK of the TAK-988
- TAK-988, Part B: MRD design to assess the safety, tolerability, PK and PD of TAK-988
- TAK-988, Part C: MRD design to assess the safety, tolerability, PK and PD of TAK-988 and also central nervous system penetration relative to plasma concentrations of TAK-988
- TAK-988, Part D: MRD design to assess the safety, tolerability, PK and PD of TAK-988 for HE participants
- TAK-988, Part E: SRD and MRD design to assess the safety, tolerability, PK and PD of TAK-988 for Japanese origin participants
Participants in each cohort will be randomized to receive treatment with TAK-988 or matching placebo which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need).
This multi-center trial will be conducted in the United States. The overall duration of the study is approximately 10.5 months. Participants will make a final visit 7 days after receiving their last dose of study drug for a follow-up assessment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| TAK-988: Part A | Experimental | Drug: TAK-988, Drug: TAK-988 PlaceboTAK-988 tablet or TAK-988 placebo-matching tablet, orally, once on Day 1 to healthy non-Japanese participants. Sentinel dosing will be done in the first 2 cohorts of Part A (Cohorts A1 and A2 [fasted and fed dosing conditions]). Dose escalation in Cohorts A2 to A6 will be based on emerging safety/tolerability, PK, and PD data from previous cohorts. |
| TAK-988: Part B | Experimental | Drug: TAK-988, Drug: TAK-988 PlaceboTAK-988 tablet or TAK-988 placebo-matching tablet, orally, twice daily (6-hour interval) from Day 1 to Day 14 to healthy non-Japanese participants. Dose escalation will be based on review of the emerging safety/tolerability, PK, and PD data from previous cohorts and Part A. |
| TAK-988: Part C | Experimental | Drug: TAK-988, Drug: TAK-988 PlaceboTAK-988 tablet or TAK-988 placebo-matching tablet, orally, twice daily (6-hour interval) from Day 1 to Day 7 to healthy non-Japanese participants. Dose will be determined based on previous multiple-rising dose (MRD) cohorts. |
| TAK-988: Part D | Experimental | Drug: TAK-988, Drug: TAK-988 PlaceboTAK-988 tablet or TAK-988 placebo-matching tablet, orally, twice daily (6-hour interval) from Day 1 to Day 14 to HE non-Japanese participants. Dose will be determined based on previous MRD cohorts. |
| TAK-988: Part E | Experimental | Drug: TAK-988, Drug: TAK-988 PlaceboTAK-988 tablet or TAK-988 placebo-matching tablet, orally, once on Day 1, followed by a washout period of 2 days and twice daily (6- hour interval) on Day 3 and continue to Day 17 to healthy Japanese participants. Dose will be determined based on previous MRD cohorts. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Be normotensive, with no history of hypertension or use of antihypertensive medication. Blood pressure (BP) must be less than (<) 140 millimeter of mercury (mmHg) (systolic) and <90 mmHg (diastolic).
- Healthy Adult and Elderly Participants (Parts A through D)
- Must have a body mass index (BMI) greater than or equal to (>=) 18.0 and less than or equal to (<=) 30.0 kilogram per square meter (kg/m^2) at the screening visit (non-Japanese only).
- Healthy Adult Participants (Parts A, B, and C)
- Must be aged 18 to 55 years, inclusive, at the screening visit.
Key exclusion criteria (10 listed)
- Has a known hypersensitivity to any component of the formulation of TAK-988 or related compounds.
- Has a risk of suicide according to endorsement of Item 4 or 5 of the screening/baseline visit Columbia Suicide Severity Rating Scale (C-SSRS) or has made a suicide attempt in the previous 6 months.
- Has a lifetime history of major psychiatric disorder, such as bipolar disorder or schizophrenia. Participant who have history of major depressive disorder (MDD) may be included, but participants who have current active MDD or who have had active MDD in the past 6 months are excluded.
- Has a clinically significant history of head injury or head trauma.
- Has a history of cerebral ischemia, transient ischemic attack, intracranial aneurysm, or arteriovenous malformation.
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-988TAK-988 tablets. | Drug | TAK-988: Part A, TAK-988: Part B, TAK-988: Part C, TAK-988: Part D, TAK-988: Part E |
| TAK-988 PlaceboTAK-988 placebo-matching tablets. | Drug | TAK-988: Part A, TAK-988: Part B, TAK-988: Part C, TAK-988: Part D, TAK-988: Part E |
Primary outcome
Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs)
Time frame: Baseline up to Day 26
Number of Participants With at Least one Markedly Abnormal Value (MAV) for Laboratory Values
Time frame: Baseline up to Day 26
Number of Participants With at Least one MAV for Vital Signs
Time frame: Baseline up to Day 26
Number of Participants With at Least one MAV for Electrocardiograms (ECGs)
Time frame: Baseline up to Day 26
9 secondary outcomes
Cmax: Maximum Observed Plasma Concentration for TAK-988
Time frame: Day 1 (Parts A-E), Day 7 (Part C), Day 14 (Parts B and D), Day 17 (Part E) pre-dose and at multiple time points (up to 72 hours) post-dose
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-988
Time frame: Day 1 (Parts A-E), Day 7 (Part C), Day 14 (Parts B and D), Day 17 (Part E) pre-dose and at multiple time points (up to 72 hours) post-dose
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-988
Time frame: Day 1 (Parts A-E) pre-dose and at multiple time points (up to 72 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-988
Time frame: Day 1 (Parts A-E) pre-dose and at multiple time points (up to 72 hours) post-dose
T1/2z: Terminal Disposition Phase Half-life for TAK-988
Time frame: Day 1 (Parts A-E) pre-dose and at multiple time points (up to 72 hours) post-dose
CLR: Renal Clearance for TAK-988
Time frame: Day 1 (Parts A, B, D and E), Day 14 (Parts B and D), Day 17 (Part E) pre-dose and at multiple time points (up to 72 hours) post-dose
AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to tau over Dosing Interval for TAK-988
Time frame: Day 7 (Part C), Day 14 (Parts B and D), Day 17 (Part E) pre-dose and at multiple time points (up to 72 hours) post-dose
Part C: Ratio of the Cerebrospinal Fluid (CSF) to Plasma AUC From Time 0 to 24 Hours for TAK-988
Time frame: Day 7 (Part C) Pre-dose and at multiple time points (up to 24 hours) post-dose
Rac (AUC): Accumulation Ratio Based on AUCτ for TAK-988
Time frame: Day 7 (Part C), Day 14 (Parts B and D), Day 17 (Part E) pre-dose and at multiple time points (up to 72 hours) post-dose
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 26 Nov 2021.
- Individual participant dataSharing planned: Yes. Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
Related trials for Healthy Volunteers
Not yet recruitingPhase 1
Comparison of Pharmacokinetic/Pharmacodynamic Characteristics and Safety of GZR101-80 Injection With Separately Injected, Simultaneous Doses of GZR33 Injection and Insulin Aspart
Healthy Participants
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
Active, not recruitingPhase 1
A Comparative Study to Investigate the Difference in Blood Levels of Two Different Formulations of GSK5784283
Asthma
RecruitingPhase 4
Testing Healthy Participants for Drowsiness After Single Dosing of Two Different Doses of Muscle Relaxer
Healthy Participants
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.
Medical Director study director
Takeda
2 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 TAK-988 in people with Healthy Volunteers, run by Takeda at 2 sites in United States.
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 15 inclusion and 10 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 26 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
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 Reporting one or More Treatment-emergent Adverse Events (TEAEs) (time frame: Baseline up to Day 26). The study lists 4 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 26 Nov 2021.