SafetyPhase 1NCT04691115
Safety, Tolerability and Pharmacokinetics of AM1476 in Healthy Subjects
A Phase 1 study testing AM1476 in people with Safety and Tolerability, run by AnaMar AB at 1 site in United Kingdom.
Trial summary
This is a First in Human (FIH), double-blind, randomised, placebo-controlled study designed to evaluate safety, tolerability and pharmacokinetics (PK) of single and multiple ascending oral doses of AM1476 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety, Tolerability
- What is being tested?
- AM1476
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Dec 2020to 8 Dec 2021
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males or females, of any race, between 18 and 60 years of age, inclusive.
- A body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive.
- 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 non-haemolytic hyperbilirubinemia [eg, suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at Screening and/or Check-in (Day -1) as assessed by the Investigator (or designee).
- Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception as detailed in Appendix 4.
- Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
Who cannot join
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
- 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).
- Any of the following observed in at least 2 of 3 ECG measurements performed:
- QTcF > 450 msec.
- QRS duration > 110 msec.
Show all 28Show fewer
- PR interval > 220 msec.
- findings which would make QTc measurements difficult or QTc data uninterpretable.
- Any history of additional risk factors for torsades de pointes (eg, heart failure, hypokalaemia, family history of long QT syndrome).
- Any history or current controlled or uncontrolled hypertension or systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg confirmed by repeat measurement.
- History of alcoholism or drug/chemical abuse within 2 years prior to Check-in (Day -1).
- 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 (Day -1).
- Positive hepatitis panel and/or positive human immunodeficiency virus test (Appendix 2).
- Participation in a clinical study involving administration of an investigational drug (new chemical entity) 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 (Day -1), unless deemed acceptable by the Investigator (or designee).
- Use or intend to use any non-prescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations within 7 days prior to Check-in (Day -1), unless deemed acceptable by the Investigator (or designee).
- Use of tobacco- or nicotine-containing products within 3 months prior to Check-in (Day -1) or positive cotinine at Screening or Check-in (Day -1).
- Ingestion of poppy seeds, Seville orange, or grapefruit-containing foods or beverages within 7 days prior to Check-in (Day -1).
- Subjects who are vegetarians, vegans, or are unable to consume the high-fat breakfast (subjects who will participate in a food-effect evaluation only).
- Receipt of blood products within 2 months prior to Check-in (Day -1).
- Donation of blood from 3 months prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening.
- Poor peripheral venous access.
- Have previously completed or withdrawn from this study or any other study investigating AM1476, and have previously received AM1476.
- Subjects who are not willing to minimise or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) following administration of study drug until 2 weeks after the last dose.
- Subjects who, in the opinion of the Investigator (or designee), should not participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: AM1476 - A Phase I, Double-blind, Placebo-controlled, Single- and Multiple-oral Dose, Safety, Tolerability, and Pharmacokinetic Study in Healthy Subjects
This is a First in Human (FIH), double-blind, randomised, placebo-controlled study designed to evaluate safety, tolerability and pharmacokinetics (PK) of single and multiple ascending oral doses of AM1476 in healthy subjects.
Read the detailed description
Part A (SAD); In the SAD part of the study, single oral doses of AM1476 will be administered in up to 9 sequential groups, each consisting of 8 subjects randomised to receive either AM1476 or placebo in a 3:1 ratio. The first 2 subjects in each group will be dosed in a sentinel fashion, 1 subject will receive AM1476 and the other will receive placebo as randomised.
Part B (MAD); The MAD part of the study will explore multiple ascending dosing of AM1476 for 10 days. AM1476 will be administered in up to 6 sequential groups, each consisting of 8 subjects randomised to receive either AM1476 or placebo in a 3:1 ratio.
- Conditions
- Safety, Tolerability
- Being tested
- AM1476, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AM1476Drug
AM1476 Capsules
PlaceboDrug
Placebo Capsules
| Study group | Role | What they receive |
|---|---|---|
| Part A, Group 1: AM1476 1 mg | Experimental | Part A, Group 1: AM1476 1 mg capsule, orally once on Day 1 in fasted state Receives: Drug: AM1476 |
| Part A, Group 2: AM1476 5 mg | Experimental | Part A, Group 2: AM1476 5 mg capsule, orally once on Days 1 in fasted state Receives: Drug: AM1476 |
| Part A, Group 3: AM1476 25 mg | Experimental | Part A, Group 3: AM1476 25 mg capsule, orally once on Days 1 in fasted state Receives: Drug: AM1476 |
| Part A, Group 4: AM1476 125 mg | Experimental | Part A, Group 4: AM1476 125 mg capsule, orally once on Days 1 in fasted state Receives: Drug: AM1476 |
| Part A, Group 5: AM1476 375 mg | Experimental | Part A, Group 5: AM1476 375 mg capsule, orally once on Days 1 in fasted state Receives: Drug: AM1476 |
| Part A, Group 6: AM1476 650 mg | Experimental | Part A, Group 6: AM1476 650 mg capsule, orally once on Days 1 in fasted state Receives: Drug: AM1476 |
| Part A, Group 7: AM1476 950 mg | Experimental | Part A, Group 7: AM1476 950 mg capsule, orally once on Days 1 in fasted state Receives: Drug: AM1476 |
| Part A, Group 8: AM1476 1500 mg | Experimental | Part A, Group 8: AM1476 1500 mg capsule, orally once on Days 1 in fasted state Receives: Drug: AM1476 |
| Part A, Group 9: AM1476 2400 mg | Experimental | Part A, Group 9: AM1476 2400 mg capsule, orally once on Days 1 in fasted state Receives: Drug: AM1476 |
| Part A, Groups 1 to 9: Placebo | Placebo comparator | Part A, Groups 1 to 9: AM1476 placebo-matching capsule, orally once on Days 1 in fasted state Receives: Drug: Placebo |
| Part B, Group 1: AM1476 100 mg QD (once daily) | Experimental | Part B, Group 1: AM1476 100 mg capsule, orally once on Days 1-10 in fasted state Receives: Drug: AM1476 |
| Part B, Group 2: AM1476 375 mg BID (twice daily) | Experimental | Part B, Group 2: AM1476 375 mg capsule, orally twice on Days 1-9 and once on Days 10 in fasted state Receives: Drug: AM1476 |
| Part B, Group 3: AM1476 500 mg BID | Experimental | Part B, Group 3: AM1476 500 mg capsule, orally twice on Days 1-9 and once on Days 10 in fasted state Receives: Drug: AM1476 |
| Part B, Groups 1 to 3: Placebo | Placebo comparator | Part B, Groups 1 to 3: AM1476 placebo-matching capsule, orally once or twice on Days 1-10 in fasted state Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events
A treatment-emergent adverse-event (TEAE) was defined as an adverse event that started during or after first dosing, or started prior to first dosing and increased in severity after first dosing.
Measured: Through study completion, an average of 7 weeks
Secondary outcomes (12)
Cmax
maximum plasma concentration
Measured: From pre-dose to up to 48 hours post-dose
Cmax
maximum plasma concentration
Measured: Day 1: From pre-dose up to 24 hours post first dose after QD dosing and from pre-dose up to 12 hours post first dose after BID dosing. Day 10: From pre-dose up to 48 hours post last dose.
Tmax
time to Cmax
Measured: From pre-dose to up to 48 hours post-dose
Tmax
time to Cmax
Measured: Day 1: From pre-dose up to 24 hours post first dose after QD dosing and from pre-dose up to 12 hours post first dose after BID dosing. Day 10: From pre-dose up to 48 hours post last dose.
T½
terminal half-life
Measured: From pre-dose to up to 48 hours post-dose
T½
terminal half-life
Measured: Day 1: From pre-dose up to 24 hours post first dose after QD dosing and from pre-dose up to 12 hours post first dose after BID dosing. Day 10: From pre-dose up to 48 hours post last dose.
AUC0-tlast
area under the curve from time 0 to time of the last quantifiable concentration
Measured: From pre-dose to up to 48 hours post-dose
AUC0-tau
area under the curve over a dosing interval (tau)
Measured: Day 1: From pre-dose up to 24 hours post first dose after QD dosing and from pre-dose up to 12 hours post first dose after BID dosing. Day 10: From pre-dose up to 48 hours post last dose.
CL/F
apparent total clearance
Measured: From pre-dose to up to 48 hours post-dose
CL/F
apparent total clearance
Measured: Day 1: From pre-dose up to 24 hours post first dose after QD dosing and from pre-dose up to 12 hours post first dose after BID dosing. Day 10: From pre-dose up to 48 hours post last dose.
Vz/F
apparent volume of distribution during the terminal phase
Measured: From pre-dose to up to 48 hours post-dose
Vz/F
apparent volume of distribution during the terminal phase
Measured: Day 1: From pre-dose up to 24 hours post first dose after QD dosing and from pre-dose up to 12 hours post first dose after BID dosing. Day 10: From pre-dose up to 48 hours post last dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start16 Dec 2020
- Primary completion8 Dec 2021
- Study completion8 Dec 2021
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 SafetyStudies 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
- Model description
- Part A (SAD) Within each group, subjects will be randomised in a 3:1 ratio to receive either AM1476 (n=6) or placebo (n=2). The first 2 subjects in each group will be dosed in a sentinel fashion; 1 subject will receive AM1476 and the other will receive placebo as randomised. Part B (MAD) Within each group, subjects will be randomised in a 3:1 ratio to receive either AM1476 (n=6) or placebo (n=2).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- AnaMar AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Covance
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04691115
- Sponsor's protocol ID
- 1476-291-001
- Status last verified
- Feb 2024
- First submitted
- 15 Dec 2020
- Last updated
- 2 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AM1476 - A Phase I, Double-blind, Placebo-controlled, Single- and Multiple-oral Dose, Safety, Tolerability, and Pharmacokinetic Study in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04691115
- Acronym / sponsor ID
- 1476-291-001
- Conditions
- Safety, Tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- AnaMar ABIndustry (pharma, biotech, devices)
- Collaborators
- Covance
- Study start
- 16 Dec 2020 (actual)
- Primary completion
- 8 Dec 2021 (actual)
- Study completion
- 8 Dec 2021 (actual)
- First posted
- 31 Dec 2020 (actual)
- Results
- Posted 2 Aug 2024
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 First in Human (FIH), double-blind, randomised, placebo-controlled study designed to evaluate safety, tolerability and pharmacokinetics (PK) of single and multiple ascending oral doses of AM1476 in healthy subjects.
Detailed description
Part A (SAD); In the SAD part of the study, single oral doses of AM1476 will be administered in up to 9 sequential groups, each consisting of 8 subjects randomised to receive either AM1476 or placebo in a 3:1 ratio. The first 2 subjects in each group will be dosed in a sentinel fashion, 1 subject will receive AM1476 and the other will receive placebo as randomised.
Part B (MAD); The MAD part of the study will explore multiple ascending dosing of AM1476 for 10 days. AM1476 will be administered in up to 6 sequential groups, each consisting of 8 subjects randomised to receive either AM1476 or placebo in a 3:1 ratio.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 14
- Model description
- Part A (SAD) Within each group, subjects will be randomised in a 3:1 ratio to receive either AM1476 (n=6) or placebo (n=2). The first 2 subjects in each group will be dosed in a sentinel fashion; 1 subject will receive AM1476 and the other will receive placebo as randomised. Part B (MAD) Within each group, subjects will be randomised in a 3:1 ratio to receive either AM1476 (n=6) or placebo (n=2).
| Arm | Type | Receives |
|---|---|---|
| Part A, Group 1: AM1476 1 mg | Experimental | Drug: AM1476Part A, Group 1: AM1476 1 mg capsule, orally once on Day 1 in fasted state |
| Part A, Group 2: AM1476 5 mg | Experimental | Drug: AM1476Part A, Group 2: AM1476 5 mg capsule, orally once on Days 1 in fasted state |
| Part A, Group 3: AM1476 25 mg | Experimental | Drug: AM1476Part A, Group 3: AM1476 25 mg capsule, orally once on Days 1 in fasted state |
| Part A, Group 4: AM1476 125 mg | Experimental | Drug: AM1476Part A, Group 4: AM1476 125 mg capsule, orally once on Days 1 in fasted state |
| Part A, Group 5: AM1476 375 mg | Experimental | Drug: AM1476Part A, Group 5: AM1476 375 mg capsule, orally once on Days 1 in fasted state |
| Part A, Group 6: AM1476 650 mg | Experimental | Drug: AM1476Part A, Group 6: AM1476 650 mg capsule, orally once on Days 1 in fasted state |
| Part A, Group 7: AM1476 950 mg | Experimental | Drug: AM1476Part A, Group 7: AM1476 950 mg capsule, orally once on Days 1 in fasted state |
| Part A, Group 8: AM1476 1500 mg | Experimental | Drug: AM1476Part A, Group 8: AM1476 1500 mg capsule, orally once on Days 1 in fasted state |
| Part A, Group 9: AM1476 2400 mg | Experimental | Drug: AM1476Part A, Group 9: AM1476 2400 mg capsule, orally once on Days 1 in fasted state |
| Part A, Groups 1 to 9: Placebo | Placebo comparator | Drug: PlaceboPart A, Groups 1 to 9: AM1476 placebo-matching capsule, orally once on Days 1 in fasted state |
| Part B, Group 1: AM1476 100 mg QD (once daily) | Experimental | Drug: AM1476Part B, Group 1: AM1476 100 mg capsule, orally once on Days 1-10 in fasted state |
| Part B, Group 2: AM1476 375 mg BID (twice daily) | Experimental | Drug: AM1476Part B, Group 2: AM1476 375 mg capsule, orally twice on Days 1-9 and once on Days 10 in fasted state |
| Part B, Group 3: AM1476 500 mg BID | Experimental | Drug: AM1476Part B, Group 3: AM1476 500 mg capsule, orally twice on Days 1-9 and once on Days 10 in fasted state |
| Part B, Groups 1 to 3: Placebo | Placebo comparator | Drug: PlaceboPart B, Groups 1 to 3: AM1476 placebo-matching capsule, orally once or twice on Days 1-10 in fasted state |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Males or females, of any race, between 18 and 60 years of age, inclusive.
- A body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive.
- 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 non-haemolytic hyperbilirubinemia [eg, suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at Screening and/or Check-in (Day -1) as assessed by the Investigator (or designee).
- Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception as detailed in Appendix 4.
- Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
Key exclusion criteria (28 listed)
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
- 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).
- Any of the following observed in at least 2 of 3 ECG measurements performed:
- Any history of additional risk factors for torsades de pointes (eg, heart failure, hypokalaemia, family history of long QT syndrome).
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 |
|---|---|---|
| AM1476AM1476 Capsules | Drug | Part A, Group 1: AM1476 1 mg, Part A, Group 2: AM1476 5 mg, Part A, Group 3: AM1476 25 mg, Part A, Group 4: AM1476 125 mg, Part A, Group 5: AM1476 375 mg, Part A, Group 6: AM1476 650 mg, Part A, Group 7: AM1476 950 mg, Part A, Group 8: AM1476 1500 mg, Part A, Group 9: AM1476 2400 mg, Part B, Group 1: AM1476 100 mg QD (once daily), Part B, Group 2: AM1476 375 mg BID (twice daily), Part B, Group 3: AM1476 500 mg BID |
| PlaceboPlacebo Capsules | Drug | Part A, Groups 1 to 9: Placebo, Part B, Groups 1 to 3: Placebo |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events
Time frame: Through study completion, an average of 7 weeks
A treatment-emergent adverse-event (TEAE) was defined as an adverse event that started during or after first dosing, or started prior to first dosing and increased in severity after first dosing.
12 secondary outcomes
Cmax
Time frame: From pre-dose to up to 48 hours post-dose
Cmax
Time frame: Day 1: From pre-dose up to 24 hours post first dose after QD dosing and from pre-dose up to 12 hours post first dose after BID dosing. Day 10: From pre-dose up to 48 hours post last dose.
Tmax
Time frame: From pre-dose to up to 48 hours post-dose
Tmax
Time frame: Day 1: From pre-dose up to 24 hours post first dose after QD dosing and from pre-dose up to 12 hours post first dose after BID dosing. Day 10: From pre-dose up to 48 hours post last dose.
T½
Time frame: From pre-dose to up to 48 hours post-dose
T½
Time frame: Day 1: From pre-dose up to 24 hours post first dose after QD dosing and from pre-dose up to 12 hours post first dose after BID dosing. Day 10: From pre-dose up to 48 hours post last dose.
AUC0-tlast
Time frame: From pre-dose to up to 48 hours post-dose
AUC0-tau
Time frame: Day 1: From pre-dose up to 24 hours post first dose after QD dosing and from pre-dose up to 12 hours post first dose after BID dosing. Day 10: From pre-dose up to 48 hours post last dose.
CL/F
Time frame: From pre-dose to up to 48 hours post-dose
CL/F
Time frame: Day 1: From pre-dose up to 24 hours post first dose after QD dosing and from pre-dose up to 12 hours post first dose after BID dosing. Day 10: From pre-dose up to 48 hours post last dose.
Vz/F
Time frame: From pre-dose to up to 48 hours post-dose
Vz/F
Time frame: Day 1: From pre-dose up to 24 hours post first dose after QD dosing and from pre-dose up to 12 hours post first dose after BID dosing. Day 10: From pre-dose up to 48 hours post last dose.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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 AM1476 in people with Safety and Tolerability, run by AnaMar AB at 1 site in United Kingdom.
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 5 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 2 Aug 2024. 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 Kingdom. 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?
Yes. Results are posted in the registry (first posted 2 Aug 2024). 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 With Treatment-Emergent Adverse Events (time frame: Through study completion, an average of 7 weeks). 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 2 Aug 2024.