Healthy SubjectsPhase 1NCT05391880
Study of Orally Administered BEBT-503 in Healthy Subjects
A Phase 1 study testing BEBT-503 20mg, BEBT-503 40mg and BEBT-503 80mg in people with Healthy Subjects, run by BeBetter Med Inc at 1 site in Australia.
Trial summary
This is a Phase I, randomized, double-blind, placebo-controlled, first-in-human study in which the safety, tolerability, and pharmacokinetic of orally administered BEBT-503 will be assessed in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- BEBT-503 20mg, BEBT-503 40mg and BEBT-503 80mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteAustralia
- Study dates
- 26 Aug 2022to 5 Jul 2023
- 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
- Males or females, of any race, between 18 and 55 years of age, inclusive.
- Body mass index (BMI) of 18.0 to 30.0 kg/m2 (inclusive) with a minimum body weight of 50 kg. Participants with a BMI up to 32.0 kg/m2 may be enrolled with the sponsor's approval
- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia, eg, suspicion of Gilbert's syndrome based on total and direct bilirubin, is not acceptable) at Screening and Check-in as assessed by the Investigator (or designee), as applicable.
- Resting heart rate ≥ 45 bpm and ≤ 90 bpm with a single 12-lead ECG at Screening.
- Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.
- Male subjects must agree to refrain from sperm donation and females should refrain from ova donation from the date of Check-in (Day-1) until 90 days after the Follow-up visit.
- Participants have ability to swallow and retain oral medication.
- Able to comprehend and willing to sign an Information and Consent Form and to abide by the study restrictions.
Who cannot join
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
- History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed, but not cholecystectomy).
- History of malignancy (cured basal cell or squamous cell carcinoma of the skin, ductal carcinoma in situ are eligible).
- Presence of a malabsorption syndrome possibly affecting drug absorption (eg, Crohn's disease or chronic pancreatitis).
Show all 28Show fewer
- Any of the following:
- corrected QT interval by Fridericia formula> 450 msec confirmed by repeat measurement.
- QRS duration > 120 msec confirmed by repeat measurement.
- PR interval > 220 msec confirmed by repeat measurement.
- findings which would make corrected QT interval measurements difficult or corrected QT interval data uninterpretable.
- history of additional risk factors for torsade de pointes (eg, heart failure, hypokalemia, family history of long QT syndrome).
- History of alcoholism or drug/chemical abuse within 6 months prior to Check-in.
- Alcohol consumption of > 21 units per week for males and > 14 units per week for females. One unit of alcohol equals ½ pint (285 mL) of beer or lager, 1 glass (125 mL) of wine, or 1/6 gill (25 mL) of spirits.
- Positive alcohol breath test result or positive urine drug screen (confirmed by repeat) at Screening or Check-in.
- Positive hepatitis panel and/or positive human immunodeficiency virus (HIV) test.
- Participation in a clinical study involving administration of an investigational agent or vaccine (new chemical entity) or having received a biological product in the past 90 days prior to dosing.
- Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to dosing, unless deemed acceptable by the Investigator (or designee).
- Use or intend to use any prescription medications/products other than hormone replacement therapy, oral, implantable, transdermal, injectable, or intrauterine contraceptives within 14 days prior to dosing, unless deemed acceptable by the Investigator (or designee).
- Use or intend to use slow-release medications/products considered to still be active within 14 days prior to Check-in, unless deemed acceptable by the Investigator (or designee).
- Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations within 7 days prior to Check-in, unless deemed acceptable by the Investigator (or designee).
- Use of tobacco- or nicotine-containing products within 1 month prior to Check-in, or positive cotinine at Screening or Check-in.
- Receipt of blood products within 2 months prior to Check-in and donation of blood from 3 months prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening.
- Any major surgery within 4 weeks prior to first dosing.
- Poor peripheral venous access.
- Have previously completed or withdrawn from this study investigating BEBT-503, and have previously received the investigational product.
- Subject who, in the opinion of the Investigator (or designee), should not participate in this study.
- Subject is not willing to minimize or avoid exposure to natural or artificial sunlight (tanning beds or ultraviolet A/B treatment) following administration of study drug until 24 hours after the last dose.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of Orally Administered BEBT-503 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses (SAD) and Multiple Ascending Doses (MAD) in Healthy Subjects
This is a Phase I, randomized, double-blind, placebo-controlled, first-in-human study in which the safety, tolerability, and pharmacokinetic of orally administered BEBT-503 will be assessed in healthy adult subjects.
The study will consist of 2 parts: a SAD phase (Part A) enrolling a total of 5 cohorts of healthy subjects; a MAD phase (Part B) enrolling 2 cohorts of healthy subjects; One cohort of Part A will receive BEBT-503 under both fasted and fed conditions to investigate the effect of food
- Conditions
- Healthy Subjects
- Being tested
- BEBT-503 20mg, BEBT-503 40mg, BEBT-503 80mg, BEBT-503 120mg, BEBT-503 180mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BEBT-503 20mgDrug
BEBT-503 capsule
BEBT-503 40mgDrug
BEBT-503 capsule
BEBT-503 80mgDrug
BEBT-503 capsule
BEBT-503 120mgDrug
BEBT-503 capsule
BEBT-503 180mgDrug
BEBT-503 capsule
placebo 20mgDrug
placebo capsule
placebo 40mgDrug
placebo capsule
placebo 80mgDrug
placebo capsule
placebo 120mgDrug
placebo capsule
placebo 180mgDrug
placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| Drug:BEBT-503 | Experimental | BEBT-503 Receives: Drug: BEBT-503 20mg; Drug: BEBT-503 40mg; Drug: BEBT-503 80mg; Drug: BEBT-503 120mg; Drug: BEBT-503 180mg |
| Drug: Placebo | Placebo comparator | Placebo Receives: Drug: placebo 20mg; Drug: placebo 40mg; Drug: placebo 80mg; Drug: placebo 120mg; Drug: placebo 180mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
single dose safety
Number of the Adverse Events that are related to the single dose treatment from baseline to Day 10
Measured: from baseline to Day10
multiple dose safety
Number of the Adverse Events that are related to the multiple dose treatment from baseline to Day 18
Measured: from baseline to Day18
Secondary outcomes (22)
AUC0-∞ after single dose
PK characteristics after single dose
Measured: Pre-dose to 48 hours postdose
Cmax after single dose
PK characteristics after single dose
Measured: Pre-dose to 48 hours postdose
t1/2 after single dose
PK characteristics after single dose
Measured: Pre-dose to 48 hours postdose
Tmax after single dose
PK characteristics after single dose
Measured: Pre-dose to 48 hours postdose
CL/F after single dose
PK characteristics after single dose
Measured: Pre-dose to 48 hours postdose
Vz/F after single dose
PK characteristics after single dose
Measured: Pre-dose to 48 hours postdose
AUC0-τ after multiple dose
PK characteristics after multiple dose
Measured: Day 1: pre-am dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24hours post-am dose Days 4 to 9: pre-am dose Day 10: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-final dose
AUC0-∞ after multiple dose
PK characteristics after multiple dose
Measured: Day 1: pre-am dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24hours post-am dose Days 4 to 9: pre-am dose Day 10: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-final dose
Cmax after multiple dose
PK characteristics after multiple dose
Measured: Day 1: pre-am dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24hours post-am dose Days 4 to 9: pre-am dose Day 10: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-final dose
t1/2 after multiple dose
PK characteristics after multiple dose
Measured: Day 1: pre-am dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24hours post-am dose Days 4 to 9: pre-am dose Day 10: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-final dose
Tmax after multiple dose
PK characteristics after multiple dose
Measured: Day 1: pre-am dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24hours post-am dose Days 4 to 9: pre-am dose Day 10: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-final dose
Cmin after multiple dose
PK characteristics after multiple dose
Measured: Day 1: pre-am dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24hours post-am dose Days 4 to 9: pre-am dose Day 10: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-final dose
RAAUC0-τ after multiple dose
PK characteristics after multiple dose
Measured: Day 1: pre-am dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24hours post-am dose Days 4 to 9: pre-am dose Day 10: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-final dose
RACmax after multiple dose
PK characteristics after multiple dose
Measured: Day 1: pre-am dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24hours post-am dose Days 4 to 9: pre-am dose Day 10: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-final dose
effect of food on the single oral dose AUC0-∞
effect of food on the single oral dose PK
Measured: Pre-dose to 48 hours postdose
effect of food on the single oral dose Cmax
effect of food on the single oral dose PK
Measured: Pre-dose to 48 hours postdose
effect of food on the single oral dose Tmax
effect of food on the single oral dose PK
Measured: Pre-dose to 48 hours postdose
effect of food on the single oral dose t1/2
effect of food on the single oral dose PK
Measured: Pre-dose to 48 hours postdose
effect of food on the single oral dose CL/F
effect of food on the single oral dose PK
Measured: Pre-dose to 48 hours postdose
effect of food on the single oral dose Vz/F
effect of food on the single oral dose PK
Measured: Pre-dose to 48 hours postdose
metabolites of BEBT-503 in urine
metabolites analysis
Measured: Pre-dose to 48 hours postdose
metabolites of BEBT-503 in plasma
metabolites analysis
Measured: Pre-dose to 48 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start26 Aug 2022
- Primary completion29 May 2023
- Study completion5 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- BeBetter Med Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jason Lickliter, CMO, Study director, Nucleus Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05391880
- Sponsor's protocol ID
- GBMT-503-P01
- Status last verified
- May 2022
- First submitted
- 12 May 2022
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study of Orally Administered BEBT-503 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses (SAD) and Multiple Ascending Doses (MAD) in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05391880
- Acronym / sponsor ID
- GBMT-503-P01
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- BeBetter Med IncIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2022 (actual)
- Primary completion
- 29 May 2023 (actual)
- Study completion
- 5 Jul 2023 (actual)
- First posted
- 26 May 2022 (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 is a Phase I, randomized, double-blind, placebo-controlled, first-in-human study in which the safety, tolerability, and pharmacokinetic of orally administered BEBT-503 will be assessed in healthy adult subjects.
The study will consist of 2 parts: a SAD phase (Part A) enrolling a total of 5 cohorts of healthy subjects; a MAD phase (Part B) enrolling 2 cohorts of healthy subjects; One cohort of Part A will receive BEBT-503 under both fasted and fed conditions to investigate the effect of food
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug:BEBT-503 | Experimental | Drug: BEBT-503 20mg, Drug: BEBT-503 40mg, Drug: BEBT-503 80mg, Drug: BEBT-503 120mg, Drug: BEBT-503 180mgBEBT-503 |
| Drug: Placebo | Placebo comparator | Drug: placebo 20mg, Drug: placebo 40mg, Drug: placebo 80mg, Drug: placebo 120mg, Drug: placebo 180mgPlacebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Males or females, of any race, between 18 and 55 years of age, inclusive.
- Body mass index (BMI) of 18.0 to 30.0 kg/m2 (inclusive) with a minimum body weight of 50 kg. Participants with a BMI up to 32.0 kg/m2 may be enrolled with the sponsor's approval
- In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia, eg, suspicion of Gilbert's syndrome based on total and direct bilirubin, is not acceptable) at Screening and Check-in as assessed by the Investigator (or designee), as applicable.
- Resting heart rate ≥ 45 bpm and ≤ 90 bpm with a single 12-lead ECG at Screening.
- Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception.
Key exclusion criteria (28 listed)
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
- History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee).
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed, but not cholecystectomy).
- History of malignancy (cured basal cell or squamous cell carcinoma of the skin, ductal carcinoma in situ are eligible).
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 |
|---|---|---|
| BEBT-503 20mgBEBT-503 capsule | Drug | Drug:BEBT-503 |
| BEBT-503 40mgBEBT-503 capsule | Drug | Drug:BEBT-503 |
| BEBT-503 80mgBEBT-503 capsule | Drug | Drug:BEBT-503 |
| BEBT-503 120mgBEBT-503 capsule | Drug | Drug:BEBT-503 |
| BEBT-503 180mgBEBT-503 capsule | Drug | Drug:BEBT-503 |
| placebo 20mgplacebo capsule | Drug | Drug: Placebo |
| placebo 40mgplacebo capsule | Drug | Drug: Placebo |
| placebo 80mgplacebo capsule | Drug | Drug: Placebo |
| placebo 120mgplacebo capsule | Drug | Drug: Placebo |
| placebo 180mgplacebo capsule | Drug | Drug: Placebo |
Primary outcome
single dose safety
Time frame: from baseline to Day10
Number of the Adverse Events that are related to the single dose treatment from baseline to Day 10
multiple dose safety
Time frame: from baseline to Day18
Number of the Adverse Events that are related to the multiple dose treatment from baseline to Day 18
22 secondary outcomes
AUC0-∞ after single dose
Time frame: Pre-dose to 48 hours postdose
Cmax after single dose
Time frame: Pre-dose to 48 hours postdose
t1/2 after single dose
Time frame: Pre-dose to 48 hours postdose
Tmax after single dose
Time frame: Pre-dose to 48 hours postdose
CL/F after single dose
Time frame: Pre-dose to 48 hours postdose
Vz/F after single dose
Time frame: Pre-dose to 48 hours postdose
AUC0-τ after multiple dose
Time frame: Day 1: pre-am dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24hours post-am dose Days 4 to 9: pre-am dose Day 10: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-final dose
AUC0-∞ after multiple dose
Time frame: Day 1: pre-am dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24hours post-am dose Days 4 to 9: pre-am dose Day 10: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-final dose
Cmax after multiple dose
Time frame: Day 1: pre-am dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24hours post-am dose Days 4 to 9: pre-am dose Day 10: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-final dose
t1/2 after multiple dose
Time frame: Day 1: pre-am dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24hours post-am dose Days 4 to 9: pre-am dose Day 10: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-final dose
Tmax after multiple dose
Time frame: Day 1: pre-am dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24hours post-am dose Days 4 to 9: pre-am dose Day 10: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-final dose
Cmin after multiple dose
Time frame: Day 1: pre-am dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24hours post-am dose Days 4 to 9: pre-am dose Day 10: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-final dose
RAAUC0-τ after multiple dose
Time frame: Day 1: pre-am dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24hours post-am dose Days 4 to 9: pre-am dose Day 10: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-final dose
RACmax after multiple dose
Time frame: Day 1: pre-am dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24hours post-am dose Days 4 to 9: pre-am dose Day 10: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-final dose
effect of food on the single oral dose AUC0-∞
Time frame: Pre-dose to 48 hours postdose
effect of food on the single oral dose Cmax
Time frame: Pre-dose to 48 hours postdose
effect of food on the single oral dose Tmax
Time frame: Pre-dose to 48 hours postdose
effect of food on the single oral dose t1/2
Time frame: Pre-dose to 48 hours postdose
effect of food on the single oral dose CL/F
Time frame: Pre-dose to 48 hours postdose
effect of food on the single oral dose Vz/F
Time frame: Pre-dose to 48 hours postdose
metabolites of BEBT-503 in urine
Time frame: Pre-dose to 48 hours postdose
metabolites of BEBT-503 in plasma
Time frame: Pre-dose to 48 hours postdose
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 18 Sep 2023.
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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.
Jason Lickliter, CMO study director
Nucleus Network
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 BEBT-503 20mg, BEBT-503 40mg and BEBT-503 80mg in people with Healthy Subjects, run by BeBetter Med Inc at 1 site in Australia.
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 8 inclusion and 28 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 18 Sep 2023. 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 Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
single dose safety (time frame: from baseline to Day10). The study lists 2 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 18 Sep 2023.