Acinetobacter Baumannii-calcoaceticus Complex InfectionsPhase 1NCT03985410
Study Evaluating the Effect of ETX2514 on Cardiac Repolarization in Healthy Male or Female Volunteers
A Phase 1 study testing ETX2514 and moxifloxacin in people with Acinetobacter Baumannii-calcoaceticus Complex Infections, run by Entasis Therapeutics at 1 site in United States.
Trial summary
This study is being conducted to evaluate the effects of supratherapeutic ETX2514 plasma concentrations on the heart rate-corrected QT interval (QTc). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Acinetobacter Baumannii-calcoaceticus Complex Infections
- What is being tested?
- ETX2514 and moxifloxacin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2019to 24 Jul 2019
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, adult, male or female, 18-55 years of age, inclusive, at Screening
- Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dose
- Must weigh at least 60 kilograms (kg) for males or 52 kg for females and have a body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/meters squared (m^2) at Screening.
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or electrocardiograms (ECGs), as deemed by the Principal Investigator (PI)
- Women of childbearing potential (i.e., not post-menopausal or surgically sterilized) must have a negative serum pregnancy test before randomization. Participating heterosexual women of childbearing potential must be willing to consistently use 2 highly effective methods of contraception (i.e., condom with spermicide, combined oral contraceptive, implant, injectable, indwelling intrauterine device, or a vasectomized partner) from Screening until at least 30 days after administration of the last dose of study drug; and
- Non-childbearing women must have had a hysterectomy, surgical sterilization, or be postmenopausal at least 12 months prior to Screening.
Show all 19Show fewer
- Male participants must be willing to use condoms with spermicide during sexual intercourse from Screening until at least 90 days after administration of the last dose of study drug.
- Male participants with a vasectomy must have had the vasectomy at least 90 days prior to randomization.
- Male participants must agree not to donate sperm from the Screening period through 90 days after the last dose.
- Understands the study procedures in the informed consent form and is willing and able to comply with the protocol
- Able to swallow tablets
- Supine blood pressure between 90/40 millimeters of mercury (mmHg) and 140/90 mmHg (inclusive) at Screening
- No clinically significant history or presence of ECG findings as judged by the PI at Screening and check-in, including each criterion as listed below:
- Normal sinus rhythm (heart rate between 45 beats per minute [bpm] and 100 bpm inclusive);
- Fridericia-corrected QTc (QTcF) interval < 450 milliseconds (msec);
- QRS interval ≤ 110 msec; and confirmed by manual over read if > 110 msec;
- PR interval ≤ 220 msec;
- No electrographically significant abnormalities that might interfere with ECG analysis including evidence of a previous myocardial infarction (MI), significant left ventricular hypertrophy (LVH), flat T-waves (particularly in the inferior leads) or more than minor non-specific ST-T wave changes
- Has serum potassium, calcium, and magnesium levels within the normal range at Screening
Who cannot join
- Participant is mentally or legally incapacitated or has significant emotional problems at the time of the Screening visit or expected during the conduct of the study.
- History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI
- History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the participant by their participation in the study
- History or presence of alcoholism or drug abuse within the past 2 years prior to the first dose of study drug
- History or presence of hypersensitivity or idiosyncratic reaction to the study drugs, related compounds, or inactive ingredients
- History of significant multiple and/or severe allergies (e.g., latex allergy, band aids, adhesive dressing, or medical tape), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs
Show all 30Show fewer
- Female participants who are pregnant or lactating
- Positive urine drug or alcohol results at Screening or check-in
- Positive results at Screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV)
- Unable to refrain from or anticipates the use of:
- Any drug, including prescription and non-prescription medications (including antacids), herbal remedies, or vitamin supplements (especially those containing magnesium, aluminum, iron, or zinc) beginning 14 days prior to the first dose of study drug and throughout the study. Co-administration of ETX2514 and probenecid is prohibited.
- Any drugs known to be significant inhibitors or inducers of cytochrome P450 (CYP) enzymes and/or permeability glycoprotein (P-gp), including St. John's Wort, for 28 days prior to the first dose of study drug and throughout the study.
- Has been on a diet incompatible with the on-study diet (including an extreme diet which resulted in a significant weight change for whatever reason), in the opinion of the PI, within the 28 days prior to the first dose of study drug, and throughout the study
- Donation of blood or significant blood loss more than 500 milliliters (mL) within 56 days prior to the first dose of study drug
- Plasma donation within 7 days prior to the first dose of study drug
- Has had surgery or any medical condition which may affect the absorption, distribution, metabolism, or elimination of the study drug within 6 months prior to the first dose, in the opinion of the PI
- Participation in another clinical trial within 28 days prior to the first dose of study drug. The 28-day window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of the current study.
- Participation in a previous clinical trial where participant received ETX2514
- History or presence of:
- hypokalemia, in the opinion of the PI;
- risk factors for Torsades de Pointes (e.g., heart failure, cardiomyopathy, or family history of Long QT Syndrome);
- sick sinus syndrome, second- or third-degree atrioventricular block, pulmonary congestion, cardiac arrhythmia, prolonged QT interval, or conduction abnormalities;
- repeated or frequent vasovagal episodes:
- hypertension, angina, bradycardia, or severe peripheral arterial circulatory disorders;
- history or evidence of any of the following: MI, cardiac valvulopathy, cardiac surgery revascularization (coronary artery bypass grafting or percutaneous transluminal coronary angioplasty), unstable angina, cerebrovascular accident or stroke or transient ischemic attack (TIA), pacemaker; atrial fibrillation, flutter, or non-sustained or sustained ventricular tachycardia (VT); pulmonary arterial hypertension; unexplained syncope or syncope within the last 3 years regardless of etiology; and/or history of hypokalemia
- Participant has a history within the last 6 months of frequent strenuous exercise, and/or is unwilling to refrain from strenuous exercise from 7 days prior to baseline Day -1 through the last Follow-Up Visit.
- Participants who refused to abstain from caffeine-containing foods or caffeinated beverages (e.g., coffee, tea, cola, energy drinks) for 7 days prior to Day -1 through the last Follow-up Visit
- Participants who refused to abstain from alcohol from 7 days prior to Day -1 through the last Follow-Up Visit
- Participants who refused to abstain from grapefruit-containing foods or beverages or Seville orange-containing foods or beverages from 2 weeks prior to Day -1 through the last Follow-Up Visit
- Participant has consumed cruciferous vegetables (e.g., kale, broccoli, watercress, collard greens, kohlrabi, Brussels sprouts, and mustard greens) or charbroiled meats within 7 days prior to check-in through the last Follow-up Visit
Trial locations and contacts
1 site in 1 country.
United States1 site
Pharmaron Clinical Pharmacology Center
Baltimore, Maryland, 21201
About this study
Official title: A Randomized, Three Period Crossover Thorough QT (TQT) Study Evaluating the Effect of ETX2514 on Cardiac Repolarization in Healthy Male or Female Volunteers
This study is being conducted to evaluate the effects of supratherapeutic ETX2514 plasma concentrations on the heart rate-corrected QT interval (QTc).
- Being tested
- ETX2514, Placebo, moxifloxacin
- Keywords
- Acinetobacter baumannii-calcoaceticus, complex infections, ETX2514, cardiac repolarization, heart rate-corrected QT interval (QTc)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ETX2514Drug
intravenous infusion
PlaceboDrug
intravenous infusion
moxifloxacinDrug
oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Treatment Sequence ABC | Experimental | Participants will receive a single 3-hour intravenous (IV) infusion of 4 grams (g) of ETX2514 (supratherapeutic dose) (Treatment A), followed by a single 3-hour IV infusion of placebo for ETX2514 (Treatment B), followed by a single 3-hour IV infusion of placebo for ETX2514 and a single oral dose of 400 milligrams (mg) open-label moxifloxacin given at the end of the infusion (Treatment C). There will be 7 ± 2 days washout between treatments. Receives: Drug: ETX2514; Drug: Placebo; Drug: moxifloxacin |
| Treatment Sequence ACB | Experimental | Participants will receive a single 3-hour IV infusion of 4 g of ETX2514 (supratherapeutic dose) (Treatment A), followed by a single 3-hour IV infusion of placebo for ETX2514 and a single oral dose of 400 mg open-label moxifloxacin given at the end of the infusion (Treatment C), followed by a single 3-hour IV infusion of placebo for ETX2514 (Treatment B). There will be 7 ± 2 days washout between treatments. Receives: Drug: ETX2514; Drug: Placebo; Drug: moxifloxacin |
| Treatment Sequence BAC | Experimental | Participants will receive a single 3-hour IV infusion of placebo for ETX2514 (Treatment B), followed by a single 3-hour IV infusion of 4 g of ETX2514 (supratherapeutic dose) (Treatment A), followed by a single 3-hour IV infusion of placebo for ETX2514 and a single oral dose of 400 mg open-label moxifloxacin given at the end of the infusion (Treatment C). There will be 7 ± 2 days washout between treatments. Receives: Drug: ETX2514; Drug: Placebo; Drug: moxifloxacin |
| Treatment Sequence BCA | Experimental | Participants will receive a single 3-hour IV infusion of placebo for ETX2514 (Treatment B), followed by a single 3-hour IV infusion of placebo for ETX2514 and a single oral dose of 400 mg open-label moxifloxacin given at the end of the infusion (Treatment C), followed by a single 3-hour IV infusion of 4 g of ETX2514 (supratherapeutic dose) (Treatment A). There will be 7 ± 2 days washout between treatments. Receives: Drug: ETX2514; Drug: Placebo; Drug: moxifloxacin |
| Treatment Sequence CAB | Experimental | Participants will receive a single 3-hour IV infusion of placebo for ETX2514 and a single oral dose of 400 mg open-label moxifloxacin given at the end of the infusion (Treatment C), followed by a single 3-hour IV infusion of 4 g of ETX2514 (supratherapeutic dose) (Treatment A), followed by a single 3-hour IV infusion of placebo for ETX2514 (Treatment B). There will be 7 ± 2 days washout between treatments. Receives: Drug: ETX2514; Drug: Placebo; Drug: moxifloxacin |
| Treatment Sequence CBA | Experimental | Participants will receive a single 3-hour IV infusion of placebo for ETX2514 and a single oral dose of 400 mg open-label moxifloxacin given at the end of the infusion (Treatment C), followed by a single 3-hour IV infusion of placebo for ETX2514 (Treatment B), followed by a single 3-hour IV infusion of 4 g of ETX2514 (supratherapeutic dose) (Treatment A). There will be 7 ± 2 days washout between treatments. Receives: Drug: ETX2514; Drug: Placebo; Drug: moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Placebo-corrected change from Baseline in Fridericia-corrected QTc (QTcF) (ΔΔQTcF)
Measured: Baseline; up to Day 22
Secondary outcomes (9)
Change from baseline in heart rate (HR) (ΔHR)
Measured: Baseline; up to Day 22
Change from Baseline in QTcF (ΔQTcF)
Measured: Baseline; up to Day 22
Change from Baseline in the PR interval (ΔPR)
Measured: Baseline; up to Day 22
Change from Baseline in the QRS interval (ΔQRS)
Measured: Baseline; up to Day 22
Placebo-corrected change from Baseline in HR (ΔΔHR)
Measured: Baseline; up to Day 22
Placebo-corrected change from Baseline in PR (ΔΔPR)
Measured: Baseline; up to Day 22
Placebo-corrected change from Baseline in QRS (ΔΔQRS)
Measured: Baseline; up to Day 22
Number of participants with categorical outliers for QTcF, HR, PR, and QRS
Measured: up to Day 22
Number of participants with treatment-emergent changes of T-wave morphology and U-wave presence
Measured: up to Day 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study start23 May 2019
- Primary completion24 Jul 2019
- Study completion24 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acinetobacter Baumannii-calcoaceticus Complex InfectionsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Entasis Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03985410
- Sponsor's protocol ID
- CS2514-2018-0003
- Status last verified
- Aug 2019
- First submitted
- 11 Jun 2019
- Last updated
- 30 Aug 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Three Period Crossover Thorough QT (TQT) Study Evaluating the Effect of ETX2514 on Cardiac Repolarization in Healthy Male or Female Volunteers
- ClinicalTrials.gov ID
- NCT03985410
- Acronym / sponsor ID
- CS2514-2018-0003
- Keywords
- Acinetobacter baumannii-calcoaceticus, complex infections, ETX2514, cardiac repolarization, heart rate-corrected QT interval (QTc)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Entasis TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 23 May 2019 (actual)
- Primary completion
- 24 Jul 2019 (actual)
- Study completion
- 24 Jul 2019 (actual)
- First posted
- 13 Jun 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.
This study is being conducted to evaluate the effects of supratherapeutic ETX2514 plasma concentrations on the heart rate-corrected QT interval (QTc).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence ABC | Experimental | Drug: ETX2514, Drug: Placebo, Drug: moxifloxacinParticipants will receive a single 3-hour intravenous (IV) infusion of 4 grams (g) of ETX2514 (supratherapeutic dose) (Treatment A), followed by a single 3-hour IV infusion of placebo for ETX2514 (Treatment B), followed by a single 3-hour IV infusion of placebo for ETX2514 and a single oral dose of 400 milligrams (mg) open-label moxifloxacin given at the end of the infusion (Treatment C). There will be 7 ± 2 days washout between treatments. |
| Treatment Sequence ACB | Experimental | Drug: ETX2514, Drug: Placebo, Drug: moxifloxacinParticipants will receive a single 3-hour IV infusion of 4 g of ETX2514 (supratherapeutic dose) (Treatment A), followed by a single 3-hour IV infusion of placebo for ETX2514 and a single oral dose of 400 mg open-label moxifloxacin given at the end of the infusion (Treatment C), followed by a single 3-hour IV infusion of placebo for ETX2514 (Treatment B). There will be 7 ± 2 days washout between treatments. |
| Treatment Sequence BAC | Experimental | Drug: ETX2514, Drug: Placebo, Drug: moxifloxacinParticipants will receive a single 3-hour IV infusion of placebo for ETX2514 (Treatment B), followed by a single 3-hour IV infusion of 4 g of ETX2514 (supratherapeutic dose) (Treatment A), followed by a single 3-hour IV infusion of placebo for ETX2514 and a single oral dose of 400 mg open-label moxifloxacin given at the end of the infusion (Treatment C). There will be 7 ± 2 days washout between treatments. |
| Treatment Sequence BCA | Experimental | Drug: ETX2514, Drug: Placebo, Drug: moxifloxacinParticipants will receive a single 3-hour IV infusion of placebo for ETX2514 (Treatment B), followed by a single 3-hour IV infusion of placebo for ETX2514 and a single oral dose of 400 mg open-label moxifloxacin given at the end of the infusion (Treatment C), followed by a single 3-hour IV infusion of 4 g of ETX2514 (supratherapeutic dose) (Treatment A). There will be 7 ± 2 days washout between treatments. |
| Treatment Sequence CAB | Experimental | Drug: ETX2514, Drug: Placebo, Drug: moxifloxacinParticipants will receive a single 3-hour IV infusion of placebo for ETX2514 and a single oral dose of 400 mg open-label moxifloxacin given at the end of the infusion (Treatment C), followed by a single 3-hour IV infusion of 4 g of ETX2514 (supratherapeutic dose) (Treatment A), followed by a single 3-hour IV infusion of placebo for ETX2514 (Treatment B). There will be 7 ± 2 days washout between treatments. |
| Treatment Sequence CBA | Experimental | Drug: ETX2514, Drug: Placebo, Drug: moxifloxacinParticipants will receive a single 3-hour IV infusion of placebo for ETX2514 and a single oral dose of 400 mg open-label moxifloxacin given at the end of the infusion (Treatment C), followed by a single 3-hour IV infusion of placebo for ETX2514 (Treatment B), followed by a single 3-hour IV infusion of 4 g of ETX2514 (supratherapeutic dose) (Treatment A). There will be 7 ± 2 days washout between treatments. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- Healthy, adult, male or female, 18-55 years of age, inclusive, at Screening
- Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dose
- Must weigh at least 60 kilograms (kg) for males or 52 kg for females and have a body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/meters squared (m^2) at Screening.
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs, or electrocardiograms (ECGs), as deemed by the Principal Investigator (PI)
- Women of childbearing potential (i.e., not post-menopausal or surgically sterilized) must have a negative serum pregnancy test before randomization. Participating heterosexual women of childbearing potential must be willing to consistently use 2 highly effective methods of contraception (i.e., condom with spermicide, combined oral contraceptive, implant, injectable, indwelling intrauterine device, or a vasectomized partner) from Screening until at least 30 days after administration of the last dose of study drug; and
Key exclusion criteria (30 listed)
- Participant is mentally or legally incapacitated or has significant emotional problems at the time of the Screening visit or expected during the conduct of the study.
- History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI
- History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the participant by their participation in the study
- History or presence of alcoholism or drug abuse within the past 2 years prior to the first dose of study drug
- History or presence of hypersensitivity or idiosyncratic reaction to the study drugs, related compounds, or inactive ingredients
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 |
|---|---|---|
| ETX2514intravenous infusion | Drug | Treatment Sequence ABC, Treatment Sequence ACB, Treatment Sequence BAC, Treatment Sequence BCA, Treatment Sequence CAB, Treatment Sequence CBA |
| Placebointravenous infusion | Drug | Treatment Sequence ABC, Treatment Sequence ACB, Treatment Sequence BAC, Treatment Sequence BCA, Treatment Sequence CAB, Treatment Sequence CBA |
| moxifloxacinoral tablet | Drug | Treatment Sequence ABC, Treatment Sequence ACB, Treatment Sequence BAC, Treatment Sequence BCA, Treatment Sequence CAB, Treatment Sequence CBA |
Primary outcome
Placebo-corrected change from Baseline in Fridericia-corrected QTc (QTcF) (ΔΔQTcF)
Time frame: Baseline; up to Day 22
9 secondary outcomes
Change from baseline in heart rate (HR) (ΔHR)
Time frame: Baseline; up to Day 22
Change from Baseline in QTcF (ΔQTcF)
Time frame: Baseline; up to Day 22
Change from Baseline in the PR interval (ΔPR)
Time frame: Baseline; up to Day 22
Change from Baseline in the QRS interval (ΔQRS)
Time frame: Baseline; up to Day 22
Placebo-corrected change from Baseline in HR (ΔΔHR)
Time frame: Baseline; up to Day 22
Placebo-corrected change from Baseline in PR (ΔΔPR)
Time frame: Baseline; up to Day 22
Placebo-corrected change from Baseline in QRS (ΔΔQRS)
Time frame: Baseline; up to Day 22
Number of participants with categorical outliers for QTcF, HR, PR, and QRS
Time frame: up to Day 22
Number of participants with treatment-emergent changes of T-wave morphology and U-wave presence
Time frame: up to Day 22
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 ETX2514 and moxifloxacin in people with Acinetobacter Baumannii-calcoaceticus Complex Infections, run by Entasis Therapeutics 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 19 inclusion and 30 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 30 Aug 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Placebo-corrected change from Baseline in Fridericia-corrected QTc (QTcF) (ΔΔQTcF) (time frame: Baseline; up to Day 22). 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 30 Aug 2019.