Healthy VolunteersPhase 1NCT03870555
A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of TAK-954 in Healthy Adult Participants
A Phase 1 study testing TAK-954 in people with Healthy Volunteers, run by Millennium Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, and PK of single ascending intravenous doses of TAK-954. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- TAK-954
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2019to 16 May 2019
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) greater than or equal to (>=) 18 and less than or equal to (<=) 32 kilogram per square meter (kg/m^2), weighing >=50 kilogram (kg) at screening.
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, orthostatic vital signs, or ECGs, as deemed by the Investigator or designee.
- Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dose and throughout the study, based on participant self-reporting.
Who cannot join
- History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing.
- Has infrequent bowel movements (less than approximately once per day) within 30 days prior to first dosing.
- Recent history of abnormal bowel movements, such as diarrhea, loose stools, or constipation, within 2 weeks of first dosing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, 3-Period, Incomplete Block Design Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAK-954 in Healthy Adult Participants
The purpose of this study is to evaluate the safety, tolerability, and PK of single ascending intravenous doses of TAK-954.
Read the detailed description
The drug being tested in this study is called TAK-954. This study will assess the safety, tolerability, PK and PD of single ascending TAK-954 higher intravenous doses than those previously studied.
The study will enroll approximately 6 participants. Participants will be randomly assigned (By chance, like flipping a coin) to one of the three treatment sequences-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need).
In each treatment sequence, each participant will receive 2 doses of active drug out of 3 dose levels (TAK-954 0.5 mg, TAK-954 1 mg, or TAK-954 2 mg) and 1 dose of Placebo. Dose escalation will be based on the available safety/tolerability data from the previous period.
This single center trial will be conducted in the United States. The overall time to participate in this study is approximately 73 days. Participants will make a final visit on Day 16 after receiving their last dose of study drug for a follow-up assessment.
- Conditions
- Healthy Volunteers
- Being tested
- TAK-954, TAK-954 Placebo
- Keywords
- Drug Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-954Drug
TAK-954 infusion administered intravenously.
TAK-954 PlaceboDrug
TAK-954 placebo-matching infusion intravenous.
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Period 1: TAK-954 placebo-matching infusion, administered intravenously over 60-minutes, once on Day 1 and Day 2.
Period 2: TAK-954 0.1 milligram (mg), infusion, administered intravenously over 60-minutes, once on Day 1, TAK-954 1 mg infusion, administered intravenously over 60-minutes, once on Day 2.
Period 3: TAK-954 0.1 mg, infusion, administered intravenously over 60-minutes, once on Day 1, TAK-954 2 mg infusion, administered intravenously over 60-minutes, once on Day 2.
A washout period of at least 16 days will be maintained between each Treatment Period. Receives: Drug: TAK-954; Drug: TAK-954 Placebo |
| Sequence 2 | Experimental | Period 1: TAK-954 0.1 mg, infusion, administered intravenously over 60-minutes, once on Day 1, TAK-954 0.5 mg infusion, administered intravenously over 60-minutes once on Day 2.
Period 2: TAK-954 placebo-matching infusion, administered intravenously over 60-minutes, once on Day 1 and Day 2.
Period 3: TAK-954 0.1 mg, infusion, administered intravenously over 60-minutes, once on Day 1, TAK-954 2 mg, infusion, administered intravenously over 60-minutes, once on Day 2.
A washout period of at least 16 days will be maintained between each Treatment Period. Receives: Drug: TAK-954; Drug: TAK-954 Placebo |
| Sequence 3 | Experimental | Period 1: TAK-954 0.1 mg, infusion, administered intravenously over 60-minutes, once on Day 1, TAK-954 0.5 mg, infusion, administered intravenously over 60-minutes once on Day 2.
Period 2: TAK-954 0.1 mg, infusion, administered intravenously over 60-minutes, once on Day 1, TAK-954 1 mg, infusion, administered intravenously over 60-minutes, once on Day 2.
Period 3: TAK-954 placebo-matching infusion, administered intravenously over 60-minutes, once on Day 1 and Day 2. A washout period of at least 16 days will be maintained between each Treatment Period. Receives: Drug: TAK-954; Drug: TAK-954 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) for TAK-954
Measured: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
Number of Participants With Clinically Significant Change From Baseline in Vital Signs for TAK-954
Measured: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) for TAK-954
Measured: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
Number of Participants With Clinically Notable Shifts From Baseline to Abnormal Post-dose in Clinical Laboratory Values for TAK-954
Measured: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-954
Measured: Day 2 pre-dose and at multiple time points (up to 336 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-954
Measured: Day 2 pre-dose and at multiple time points (up to 336 hours) post-dose
Ceoi: Plasma Concentration Observed at the End of Infusion for TAK-954
Measured: Day 2 pre-dose and at multiple time points (up to 336 hours) post-dose
CL: Total Clearance After Intravenous Administration for TAK-954
Measured: Day 2 pre-dose and at multiple time points (up to 336 hours) post-dose
Vz: Volume of Distribution During the Terminal Disposition Phase After Intravenous Administration for TAK-954
Measured: Day 2 pre-dose and at multiple time points (up to 336 hours) post-dose
Ae: Amount of Unchanged Drug Excreted in the Urine for TAK-954 on Day 2 up to 12 Hours Post-dose
Measured: Day 2 pre-dose and at multiple time points (up to 12 hours) post-dose
Ae: Amount of Unchanged Drug Excreted in the Urine for TAK-954 on Day 2 up to 24 Hours Post-dose
Measured: Day 2 pre-dose and at multiple time points (up to 24 hours) post-dose
Ae: Amount of Unchanged Drug Excreted in the Urine for TAK-954 on Day 2 up to 36 Hours Post-dose
Measured: Day 2 pre-dose and at multiple time points (up to 36 hours) post-dose
Fe: Fraction of TAK-954 Excreted in Urine on Day 2 up to 12 Hours Post-dose
Measured: Day 2 pre-dose and at multiple time points (up to 12 hours) post-dose
Fe: Fraction of TAK-954 Excreted in Urine on Day 2 up to 24 Hours Post-dose
Measured: Day 2 pre-dose and at multiple time points (up to 24 hours) post-dose
Fe: Fraction of TAK-954 Excreted in Urine on Day 2 up to 36 Hours Post-dose
Measured: Day 2 pre-dose and at multiple time points (up to 36 hours) post-dose
CLR: Renal Clearance for TAK-954
Measured: Day 2 pre-dose and at multiple time points (up to 36 hours) post-dose
Secondary outcomes (3)
Number of Participants With First Stool of TAK-954 Within 36 Hours Post-dose on Day 2
Measured: Day 2 dosing and at multiple time points (up to 36 hours) post-dose
Mean Number of Stools of TAK-954 Within 36 Hours Post-dose on Day 2
Measured: Day 2 dosing and at multiple time points (up to 36 hours) post-dose
Instances of Stool Type of TAK-954 Based on Bristol Stool Form Scale
Number of occurrences for each stool type was reported based on their type assessed from Bristol Stool form scale. The Bristol Stool Form Scale was used to assess the stool shape using a 7-point scale. Where, Type 1 = separate hard lumps, like nuts (hard to pass), Type 2 = sausage-shaped but lumpy, Type 3 = like a sausage but with cracks on the surface, Type 4 = like a sausage or snake, smooth and soft, Type 5 = soft blobs with clear-cut edges (passed easily), Type 6 = fluffy pieces with ragged edges, a mushy stool, Type 7 = watery, no solid pieces; entirely liquid. A score of 1 or 2 indicates constipation and a score of 6 or 7 indicates diarrhea.
Measured: Day 2 dosing and at multiple time points (up to 36 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 posted12 Mar 2019
- Study start8 Mar 2019
- Primary completion16 May 2019
- Study completion16 May 2019
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 VolunteersStudies 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Millennium Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03870555
- Sponsor's protocol ID
- TAK-954-1009
- Other IDs
- U1111-1224-9803
- Status last verified
- Jun 2020
- First submitted
- 4 Mar 2019
- Last updated
- 24 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- 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 24 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose, 3-Period, Incomplete Block Design Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAK-954 in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT03870555
- Acronym / sponsor ID
- TAK-954-1009
- Conditions
- Healthy Volunteers
- Keywords
- Drug Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Mar 2019 (actual)
- Primary completion
- 16 May 2019 (actual)
- Study completion
- 16 May 2019 (actual)
- First posted
- 12 Mar 2019 (actual)
- Results
- Posted 24 Jun 2020
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, and PK of single ascending intravenous doses of TAK-954.
Detailed description
The drug being tested in this study is called TAK-954. This study will assess the safety, tolerability, PK and PD of single ascending TAK-954 higher intravenous doses than those previously studied.
The study will enroll approximately 6 participants. Participants will be randomly assigned (By chance, like flipping a coin) to one of the three treatment sequences-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need).
In each treatment sequence, each participant will receive 2 doses of active drug out of 3 dose levels (TAK-954 0.5 mg, TAK-954 1 mg, or TAK-954 2 mg) and 1 dose of Placebo. Dose escalation will be based on the available safety/tolerability data from the previous period.
This single center trial will be conducted in the United States. The overall time to participate in this study is approximately 73 days. Participants will make a final visit on Day 16 after receiving their last dose of study drug for a follow-up assessment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: TAK-954, Drug: TAK-954 PlaceboPeriod 1: TAK-954 placebo-matching infusion, administered intravenously over 60-minutes, once on Day 1 and Day 2. Period 2: TAK-954 0.1 milligram (mg), infusion, administered intravenously over 60-minutes, once on Day 1, TAK-954 1 mg infusion, administered intravenously over 60-minutes, once on Day 2. Period 3: TAK-954 0.1 mg, infusion, administered intravenously over 60-minutes, once on Day 1, TAK-954 2 mg infusion, administered intravenously over 60-minutes, once on Day 2. A washout period of at least 16 days will be maintained between each Treatment Period. |
| Sequence 2 | Experimental | Drug: TAK-954, Drug: TAK-954 PlaceboPeriod 1: TAK-954 0.1 mg, infusion, administered intravenously over 60-minutes, once on Day 1, TAK-954 0.5 mg infusion, administered intravenously over 60-minutes once on Day 2. Period 2: TAK-954 placebo-matching infusion, administered intravenously over 60-minutes, once on Day 1 and Day 2. Period 3: TAK-954 0.1 mg, infusion, administered intravenously over 60-minutes, once on Day 1, TAK-954 2 mg, infusion, administered intravenously over 60-minutes, once on Day 2. A washout period of at least 16 days will be maintained between each Treatment Period. |
| Sequence 3 | Experimental | Drug: TAK-954, Drug: TAK-954 PlaceboPeriod 1: TAK-954 0.1 mg, infusion, administered intravenously over 60-minutes, once on Day 1, TAK-954 0.5 mg, infusion, administered intravenously over 60-minutes once on Day 2. Period 2: TAK-954 0.1 mg, infusion, administered intravenously over 60-minutes, once on Day 1, TAK-954 1 mg, infusion, administered intravenously over 60-minutes, once on Day 2. Period 3: TAK-954 placebo-matching infusion, administered intravenously over 60-minutes, once on Day 1 and Day 2. A washout period of at least 16 days will be maintained between each Treatment Period. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index (BMI) greater than or equal to (>=) 18 and less than or equal to (<=) 32 kilogram per square meter (kg/m^2), weighing >=50 kilogram (kg) at screening.
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, orthostatic vital signs, or ECGs, as deemed by the Investigator or designee.
- Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dose and throughout the study, based on participant self-reporting.
Key exclusion criteria (3 listed)
- History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing.
- Has infrequent bowel movements (less than approximately once per day) within 30 days prior to first dosing.
- Recent history of abnormal bowel movements, such as diarrhea, loose stools, or constipation, within 2 weeks of first dosing.
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-954TAK-954 infusion administered intravenously. | Drug | Sequence 1, Sequence 2, Sequence 3 |
| TAK-954 PlaceboTAK-954 placebo-matching infusion intravenous. | Drug | Sequence 1, Sequence 2, Sequence 3 |
Primary outcome
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) for TAK-954
Time frame: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
Number of Participants With Clinically Significant Change From Baseline in Vital Signs for TAK-954
Time frame: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) for TAK-954
Time frame: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
Number of Participants With Clinically Notable Shifts From Baseline to Abnormal Post-dose in Clinical Laboratory Values for TAK-954
Time frame: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-954
Time frame: Day 2 pre-dose and at multiple time points (up to 336 hours) post-dose
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-954
Time frame: Day 2 pre-dose and at multiple time points (up to 336 hours) post-dose
Ceoi: Plasma Concentration Observed at the End of Infusion for TAK-954
Time frame: Day 2 pre-dose and at multiple time points (up to 336 hours) post-dose
CL: Total Clearance After Intravenous Administration for TAK-954
Time frame: Day 2 pre-dose and at multiple time points (up to 336 hours) post-dose
Vz: Volume of Distribution During the Terminal Disposition Phase After Intravenous Administration for TAK-954
Time frame: Day 2 pre-dose and at multiple time points (up to 336 hours) post-dose
Ae: Amount of Unchanged Drug Excreted in the Urine for TAK-954 on Day 2 up to 12 Hours Post-dose
Time frame: Day 2 pre-dose and at multiple time points (up to 12 hours) post-dose
Ae: Amount of Unchanged Drug Excreted in the Urine for TAK-954 on Day 2 up to 24 Hours Post-dose
Time frame: Day 2 pre-dose and at multiple time points (up to 24 hours) post-dose
Ae: Amount of Unchanged Drug Excreted in the Urine for TAK-954 on Day 2 up to 36 Hours Post-dose
Time frame: Day 2 pre-dose and at multiple time points (up to 36 hours) post-dose
Fe: Fraction of TAK-954 Excreted in Urine on Day 2 up to 12 Hours Post-dose
Time frame: Day 2 pre-dose and at multiple time points (up to 12 hours) post-dose
Fe: Fraction of TAK-954 Excreted in Urine on Day 2 up to 24 Hours Post-dose
Time frame: Day 2 pre-dose and at multiple time points (up to 24 hours) post-dose
Fe: Fraction of TAK-954 Excreted in Urine on Day 2 up to 36 Hours Post-dose
Time frame: Day 2 pre-dose and at multiple time points (up to 36 hours) post-dose
CLR: Renal Clearance for TAK-954
Time frame: Day 2 pre-dose and at multiple time points (up to 36 hours) post-dose
3 secondary outcomes
Number of Participants With First Stool of TAK-954 Within 36 Hours Post-dose on Day 2
Time frame: Day 2 dosing and at multiple time points (up to 36 hours) post-dose
Mean Number of Stools of TAK-954 Within 36 Hours Post-dose on Day 2
Time frame: Day 2 dosing and at multiple time points (up to 36 hours) post-dose
Instances of Stool Type of TAK-954 Based on Bristol Stool Form Scale
Time frame: Day 2 dosing and at multiple time points (up to 36 hours) post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
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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.
Medical Director study director
Millennium Pharmaceuticals, Inc.
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-954 in people with Healthy Volunteers, run by Millennium Pharmaceuticals, Inc. at 1 site 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 3 inclusion and 3 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 24 Jun 2020. 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 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?
Yes. Results are posted in the registry (first posted 24 Jun 2020). 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?
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) for TAK-954 (time frame: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)). The study lists 16 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 24 Jun 2020.