HealthyPhase 1NCT04667013
A Multiple Dose Study to Investigate Safety, Tolerability and Pharmacokinetics of TBN
A Phase 1 study of Healthy, run by Guangzhou Magpie Pharmaceuticals Co., Ltd..
Trial summary
The purpose of this study is to assess the safety, tolerability and pharmacokinetics (i.e. how study drug is taken up by the body) of TBN in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2028to 30 Aug 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or non-childbearing potential female, non-smoker (no use of tobacco or nicotine products within 3 months prior to screening), ≥ 18 and ≤ 50 years of age, with BMI > 18.0 and < 30.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females.
- Healthy as defined by:
- The absence of clinically significant illness and surgery within 4 weeks prior to the first dosing. Subjects vomiting within 24 hours pre-dose will be carefully evaluated for upcoming illness/disease. Inclusion pre-dosing is at the discretion of the Investigator.
- The absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
- Non-childbearing potential female is defined as:
- Post-menopausal female (absence of menses for 12 months prior to the first study drug administration, bilateral oophorectomy or hysterectomy with bilateral oophorectomy at least 6 months prior to the first study drug administration);
Show all 14Show fewer
- or
- Surgically sterile female (hysterectomy or tubal ligation at least 6 months prior to drug administration).
- Male subjects who have not been vasectomized for at least 6 months prior, and who are sexually active with a female partner of childbearing potential (childbearing potential females are defined as women that are neither post-menopausal nor surgically sterile) must be willing to use one of the following acceptable contraceptive methods from the first study drug administration until at least 90 days after the last study drug administration:
- Simultaneous use of a male condom and, for the female partner, hormonal contraceptives used since at least 4 weeks prior or intra-uterine contraceptive device placed since at least 4 weeks prior;
- Simultaneous use of a male condom and, for the female partner, a diaphragm or cervical cap with intravaginally applied spermicide.
- Male subjects (including men who have had a vasectomy) with a pregnant partner must agree to use a condom from the first study drug administration until at least 90 days after the last study drug administration.
- Male subjects must be willing not to donate sperm until 90 days following the last study drug administration.
- Capable of consent.
Who cannot join
- Any clinically significant abnormality at physical examination, clinically significant abnormal laboratory test results or positive test for hepatitis B, hepatitis C, or HIV found during medical screening.
- Positive urine drug screen, alcohol breath test, or urine cotinine test at screening.
- History of allergic reactions to TBN or other related drugs, or to any excipient in the formulation.
- Positive pregnancy test at screening.
- Clinically significant ECG abnormalities or vital sign abnormalities, systolic BP lower than 90 or over 140 mmHg, diastolic BP lower than 50 or over 90 mmHg, or heart rate (HR) less than 50 or over 100 bpm; orthostatic BP: decrease in systolic BP of 20 mmHg or higher, decrease in diastolic BP of 10 mmHg or higher, or increase in HR of 30 bpm or higher within 2 to 3 minutes after passing from a supine to a standing position at screening.
- History of significant alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to the screening visit (more than 14 units of alcohol per week [1 unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol]).
Show all 18Show fewer
- History of significant drug abuse within 1 year prior to screening or use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine (PCP), crack, opioid derivatives including heroin, and amphetamine derivatives) within 1 year prior to screening.
- Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing, or concomitant participation in an investigational study involving no drug or device administration.
- Use of medications for the timeframes specified below, with the exception of medications exempted by the Investigator on a case-by-case basis because they are judged unlikely to affect the pharmacokinetics (PK) profile of the study drug or subject safety (e.g., topical drug products without significant systemic absorption):
- Prescription medications within 14 days prior to the first dosing;
- Over-the-counter products and natural health products (including herbal remedies, homeopathic and traditional medicines, probiotics, food supplements such as vitamins, minerals, amino acids, essential fatty acids, and protein supplements used in sports) within 7 days prior to the first dosing, with the exception of the occasional use of acetaminophen (up to 2 g daily);
- Depot injection or implant of any drug within 3 months prior to the first dosing;
- Any drugs known to induce or inhibit hepatic drug metabolism (including St. John's wort) within 30 days prior to the first dosing.
- Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to the first dosing.
- Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.
- Breast-feeding subject.
- Any history of thyroid/gland abnormalities.
- Any history of suicidal ideation or suicidal behavior (within 2 years prior to screening), as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) (baseline version).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Bridged Phase 1, Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of TBN in Healthy Subjects
The purpose of this study is to assess the safety, tolerability and pharmacokinetics (i.e. how study drug is taken up by the body) of TBN in healthy participants.
Read the detailed description
The trial is a single center, placebo-controlled, double-blind, multiple-dose study in 2 ascending dose cohorts of healthy subjects. The primary purpose of this study is to investigate the safety, tolerability and pharmacokinetic property of the multiple doses of TBN administered for 6.5 consecutive days in healthy participants.
- Conditions
- Healthy
- Being tested
- Tetramethylpyrazine nitrone (TBN) tablet / Placebo
- Keywords
- Phase 1, Amyotrophic lateral sclerosis, TBN
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tetramethylpyrazine nitrone (TBN) tablet / PlaceboDrug
Also called TBN tablet / Placebo
Subjects will be administered multiple oral doses of TBN or matching placebo tablets twice a day for 6 consecutive days and a last dose in the morning of Day 7.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | 2 x 300 mg TBN tablets for a total dose of 600 mg or 2 matching placebo tablets (given approximately every 12 hours) for 6.5 consecutive days, until the morning dose of Day 7. Receives: Drug: Tetramethylpyrazine nitrone (TBN) tablet / Placebo |
| Cohort 2 | Experimental | 4 x 300 mg TBN tablets for a total dose of 1200 mg or 4 matching placebo tablets (given approximately every 12 hours) for 6.5 consecutive days, until the morning dose of Day 7. Receives: Drug: Tetramethylpyrazine nitrone (TBN) tablet / Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Adverse Events (AEs)
The number and severity of AEs will be graded according to criteria from the NCI-CTCAE (i.e., seriousness, severity, relationship to the study medication, outcome, duration, and management).
Measured: 14 days
Assessment of physical examination.
Physical examination will be assessed on Day-1, Day4, and check-out (Day8), follow-up visit (Day14±2).
Measured: 14 days
Assessment of vital signs.
Vital signs, including orthostatic blood pressure and heart rate, respiratory rate and oral temperature, will be evaluated from Day-1 to check-out (Day8), and at follow-up visit (Day14±2).
Measured: 14 days
Assessment of 12 lead-ECG.
12 lead-ECG will be assessed on Day-1, Day4, Day 7 and at check-out (Day8), follow-up visit (Day14±2).
Measured: 14 days
Assessment of urine pregnancy.
Urine pregnancy test will be assessed on Day-1 and at follow-up visit (Day14±2).
Measured: 14 days
Assessment of Clinical Laboratory Tests.
Clinical laboratory tests includes hematology, clinical chemistry, coagulation (prothrombin time and partial thromboplastin time), endocrinology (T3, T4, and thyroid stimulating hormone) and urinalysis, will be assessed on Day-1, Day2, Day4, Day6 and at check-out (Day8), follow-up visit (Day14±2).
Measured: 14 days
Secondary outcomes (11)
Maximum observed concentration (Cmax) of TBN and its metabolite.
Plasma concentrations of TBN and its metabolite [Time point: pre-dose, 1, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12 (prior to the second dose)], and derived pharmacokinetic parameters Cmax.
Measured: 0 to 12 hours after on the morning dosing of the first day
Time of occurrence of Cmax (Tmax) of TBN and its metabolite.
Plasma concentrations of TBN and its metabolite [Time point: pre-dose, 1, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12 (prior to the second dose)], and derived pharmacokinetic parameters Tmax.
Measured: 0 to 12 hours after on the morning dosing of the first day
Area under the concentration-time curve from time zero to time 12 hours (AUC0-12) of TBN and its metabolite.
Plasma concentrations of TBN and its metabolite [Time point: pre-dose, 1, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12 (prior to the second dose)], and derived pharmacokinetic parameters AUC0-12.
Measured: 0 to 12 hours after on the morning dosing of the first day
Lowest concentration before the next dose is administered (Ctrough) of TBN and its metabolite.
Time point: pre-morning dose of Day2, Day3, Day4, Day5 and Day6.
Measured: From Day2 to Day6
Area under the concentration-time curve for one dosing interval (12 hours) at steady-state (AUC0-tau) of TBN and its metabolite.
Plasma concentrations of TBN and its metabolite [Time point: pre-dose, and 1, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 14, and 24 hours after the last dose at Day7], and derived pharmacokinetic parameters AUC0-tau.
Measured: 0-24 hours after the last dose at Day7
Average drug concentration calculated at AUC0-tau/tau (Caverage) of TBN and its metabolite.
Plasma concentrations of TBN and its metabolite [Time point: Time frame: pre-dose, and 1, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 14, and 24 hours after the last dose at Day7], and derived pharmacokinetic parameters Caverage.
Measured: 0-24 hours after the last dose at Day7
Minimum observed concentration at steady-state (Cmin_ss) of TBN and its metabolite.
Plasma concentrations of TBN and its metabolite [Time point: Time frame: pre-dose, and 1, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 14, and 24 hours after the last dose at Day7], and derived pharmacokinetic parameters Cmin_ss.
Measured: 0-24 hours after the last dose at Day7
Area under the concentration-time curve from time zero to the 24 hours concentration (AUC0-24) of TBN and its metabolite.
Plasma concentrations of TBN and its metabolite [Time point: Time frame: pre-dose, and 1, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 14, and 24 hours after the last dose at Day7], and derived pharmacokinetic parameters AUC0-24.
Measured: 0-24 hours after the last dose at Day7
Maximum observed concentration at steady-state (Cmax_ss) of TBN and its metabolite.
Plasma concentrations of TBN and its metabolite [Time point: Time frame: pre-dose, and 1, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 14, and 24 hours after the last dose at Day7], and derived pharmacokinetic parameters Cmax_ss.
Measured: 0-24 hours after the last dose at Day7
Time of observed Cmax_ss (Tmax_ss) of TBN and its metabolite.
Plasma concentrations of TBN and its metabolite [Time point: Time frame: pre-dose, and 1, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 14, and 24 hours after the last dose at Day7], and derived pharmacokinetic parameters Tmax_ss.
Measured: 0-24 hours after the last dose at Day7
Area under the concentration-time curve from time zero to infinity (AUC0-inf) of TBN and its metabolite.
Plasma concentrations of TBN and its metabolite [Time point: Time frame: pre-dose, and 1, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 14, and 24 hours after the last dose at Day7], and derived pharmacokinetic parameters AUC0-inf.
Measured: 0-24 hours after the last dose at Day7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start1 Sep 2028 (estimated)
- Primary completion31 Mar 2029 (estimated)
- Study completion30 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Magpie Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Wyatt, VP, Principal investigator, Syneos Health Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04667013
- Sponsor's protocol ID
- 192008
- Status last verified
- Sep 2026
- First submitted
- 1 Dec 2020
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bridged Phase 1, Randomized, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of TBN in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04667013
- Acronym / sponsor ID
- 192008
- Conditions
- Healthy
- Keywords
- Phase 1, Amyotrophic lateral sclerosis, TBN
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Guangzhou Magpie Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2028 (estimated)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 30 Aug 2029 (estimated)
- First posted
- 14 Dec 2020 (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, tolerability and pharmacokinetics (i.e. how study drug is taken up by the body) of TBN in healthy participants.
Detailed description
The trial is a single center, placebo-controlled, double-blind, multiple-dose study in 2 ascending dose cohorts of healthy subjects. The primary purpose of this study is to investigate the safety, tolerability and pharmacokinetic property of the multiple doses of TBN administered for 6.5 consecutive days in healthy participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Tetramethylpyrazine nitrone (TBN) tablet / Placebo2 x 300 mg TBN tablets for a total dose of 600 mg or 2 matching placebo tablets (given approximately every 12 hours) for 6.5 consecutive days, until the morning dose of Day 7. |
| Cohort 2 | Experimental | Drug: Tetramethylpyrazine nitrone (TBN) tablet / Placebo4 x 300 mg TBN tablets for a total dose of 1200 mg or 4 matching placebo tablets (given approximately every 12 hours) for 6.5 consecutive days, until the morning dose of Day 7. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Male or non-childbearing potential female, non-smoker (no use of tobacco or nicotine products within 3 months prior to screening), ≥ 18 and ≤ 50 years of age, with BMI > 18.0 and < 30.0 kg/m2 and body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females.
- Healthy as defined by:
- Non-childbearing potential female is defined as:
- or
- Male subjects who have not been vasectomized for at least 6 months prior, and who are sexually active with a female partner of childbearing potential (childbearing potential females are defined as women that are neither post-menopausal nor surgically sterile) must be willing to use one of the following acceptable contraceptive methods from the first study drug administration until at least 90 days after the last study drug administration:
Key exclusion criteria (18 listed)
- Any clinically significant abnormality at physical examination, clinically significant abnormal laboratory test results or positive test for hepatitis B, hepatitis C, or HIV found during medical screening.
- Positive urine drug screen, alcohol breath test, or urine cotinine test at screening.
- History of allergic reactions to TBN or other related drugs, or to any excipient in the formulation.
- Positive pregnancy test at screening.
- Clinically significant ECG abnormalities or vital sign abnormalities, systolic BP lower than 90 or over 140 mmHg, diastolic BP lower than 50 or over 90 mmHg, or heart rate (HR) less than 50 or over 100 bpm; orthostatic BP: decrease in systolic BP of 20 mmHg or higher, decrease in diastolic BP of 10 mmHg or higher, or increase in HR of 30 bpm or higher within 2 to 3 minutes after passing from a supine to a standing position at screening.
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 |
|---|---|---|
| Tetramethylpyrazine nitrone (TBN) tablet / PlaceboAlso: TBN tablet / PlaceboSubjects will be administered multiple oral doses of TBN or matching placebo tablets twice a day for 6 consecutive days and a last dose in the morning of Day 7. | Drug | Cohort 1, Cohort 2 |
Primary outcome
Number of participants with Adverse Events (AEs)
Time frame: 14 days
The number and severity of AEs will be graded according to criteria from the NCI-CTCAE (i.e., seriousness, severity, relationship to the study medication, outcome, duration, and management).
Assessment of physical examination.
Time frame: 14 days
Physical examination will be assessed on Day-1, Day4, and check-out (Day8), follow-up visit (Day14±2).
Assessment of vital signs.
Time frame: 14 days
Vital signs, including orthostatic blood pressure and heart rate, respiratory rate and oral temperature, will be evaluated from Day-1 to check-out (Day8), and at follow-up visit (Day14±2).
Assessment of 12 lead-ECG.
Time frame: 14 days
12 lead-ECG will be assessed on Day-1, Day4, Day 7 and at check-out (Day8), follow-up visit (Day14±2).
Assessment of urine pregnancy.
Time frame: 14 days
Urine pregnancy test will be assessed on Day-1 and at follow-up visit (Day14±2).
Assessment of Clinical Laboratory Tests.
Time frame: 14 days
Clinical laboratory tests includes hematology, clinical chemistry, coagulation (prothrombin time and partial thromboplastin time), endocrinology (T3, T4, and thyroid stimulating hormone) and urinalysis, will be assessed on Day-1, Day2, Day4, Day6 and at check-out (Day8), follow-up visit (Day14±2).
11 secondary outcomes
Maximum observed concentration (Cmax) of TBN and its metabolite.
Time frame: 0 to 12 hours after on the morning dosing of the first day
Time of occurrence of Cmax (Tmax) of TBN and its metabolite.
Time frame: 0 to 12 hours after on the morning dosing of the first day
Area under the concentration-time curve from time zero to time 12 hours (AUC0-12) of TBN and its metabolite.
Time frame: 0 to 12 hours after on the morning dosing of the first day
Lowest concentration before the next dose is administered (Ctrough) of TBN and its metabolite.
Time frame: From Day2 to Day6
Area under the concentration-time curve for one dosing interval (12 hours) at steady-state (AUC0-tau) of TBN and its metabolite.
Time frame: 0-24 hours after the last dose at Day7
Average drug concentration calculated at AUC0-tau/tau (Caverage) of TBN and its metabolite.
Time frame: 0-24 hours after the last dose at Day7
Minimum observed concentration at steady-state (Cmin_ss) of TBN and its metabolite.
Time frame: 0-24 hours after the last dose at Day7
Area under the concentration-time curve from time zero to the 24 hours concentration (AUC0-24) of TBN and its metabolite.
Time frame: 0-24 hours after the last dose at Day7
Maximum observed concentration at steady-state (Cmax_ss) of TBN and its metabolite.
Time frame: 0-24 hours after the last dose at Day7
Time of observed Cmax_ss (Tmax_ss) of TBN and its metabolite.
Time frame: 0-24 hours after the last dose at Day7
Area under the concentration-time curve from time zero to infinity (AUC0-inf) of TBN and its metabolite.
Time frame: 0-24 hours after the last dose at Day7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Healthy
RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
RecruitingObservational study
Development of Magnetic Resonance Imaging Techniques for Studying Mood and Anxiety Disorders
Mood Disorders, Anxiety Disorders
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Not yet recruiting
Evaluating the Healthy Families PrEP Program for Women at Risk for HIV
HIV, Pregnancy
RecruitingPhase 1
A Single Ascending Dose Study of DTI-117 Given Intramuscularly in Healthy Participants.
Healthy Adult
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.
David Wyatt, VP principal investigator
Syneos Health Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Healthy, run by Guangzhou Magpie Pharmaceuticals Co., Ltd..
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 18 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: opening soon, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Wyatt, MD, VP (305-547-5857, david.wyatt@syneoshealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Adverse Events (AEs) (time frame: 14 days). The study lists 6 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 11 Sep 2026.