A First in Human Study to Assess Safety, Tolerability, Pharmacokinetics of ABI-4334 in Healthy Subjects
NCT ID: NCT05569941
Last Updated: 2023-09-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
54 participants
INTERVENTIONAL
2022-11-11
2023-04-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Part A: SAD Cohorts 1-5 ABI-4334 Tablet
A single dose of ABI-4334 will be administered on Day 1 in dose-escalation cohorts with a starting dose of 30 mg. The doses for subsequent cohorts will be determined by evaluation of safety and PK data from previous cohorts.
ABI-4334 Tablet
ABI-4334 Tablet
Part A: SAD Cohorts 1-5 ABI-4334 Placebo Tablet
A single dose of placebo matching ABI-4334 will be administered on Day 1.
ABI-4334 Placebo
Placebo to ABI-4334 Tablet
Part A: SAD Fed Cohorts 6-7 ABI-4334 Tablet
A single dose of ABI-4334 will be administered after a high-fat meal on Day 1 in cohort 6. A single dose of ABI-4334 will be administered on two separate occasions, once fasted and once after a high-fat meal in cohort 7. The dose administered will be determined after evaluation of cumulative safety and PK data from cohorts 1-5.
ABI-4334 Tablet
ABI-4334 Tablet
Part A: SAD Fed Cohorts 6 ABI-4334 Placebo Tablet
A single dose of placebo matching ABI-4334 will be administered on Day 1 after a high-fat meal on Day 1 in cohort 6.
ABI-4334 Placebo
Placebo to ABI-4334 Tablet
Part B: MAD Cohorts 1-2 ABI-4334 Tablet
Once-daily doses of ABI-4334 will be administered from Day 1 to Day 8. Cohort B1 will receive a dose determined from evaluation of the data from the SAD cohorts. The doses for the subsequent cohort will be determined by evaluation of safety and PK data from previous cohorts.
ABI-4334 Tablet
ABI-4334 Tablet
Part B: MAD Cohorts 1-2 ABI-4334 Placebo Tablet
Once-daily doses of placebo matching ABI-4334 will be administered from Day 1 to Day 8.
ABI-4334 Placebo
Placebo to ABI-4334 Tablet
Interventions
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ABI-4334 Tablet
ABI-4334 Tablet
ABI-4334 Placebo
Placebo to ABI-4334 Tablet
Eligibility Criteria
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Inclusion Criteria
* In good health (as determined by the Investigator) based on medical history, physical examination, ECG, and clinical laboratory results.
* Female subjects must be non-pregnant and have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Day 1
* Agreement to comply with protocol-specified contraceptive requirements
Exclusion Criteria
* History of any illness that, in the opinion of the Investigator, might confound the results of the study, pose an additional risk in administering study drug to the subject, or a condition known to interfere with the absorption/ distribution/elimination of drugs.
* History of any significant drug-related allergic reactions such as anaphylaxis, Stevens-Johnson syndrome, urticaria, or multiple drug allergies
* History of persistent alcohol abuse or illicit drug abuse within 3 years prior to Screening
* Has participated in a clinical study involving administration of either an investigational or a marketed drug within 2 months before Screening
18 Years
65 Years
ALL
Yes
Sponsors
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Assembly Biosciences
INDUSTRY
Responsible Party
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Principal Investigators
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Edward Gane
Role: PRINCIPAL_INVESTIGATOR
New Zealand Clinical Research
Locations
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New Zealand Clinical Research
Grafton, Auckland, New Zealand
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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ABI-4334-101
Identifier Type: -
Identifier Source: org_study_id
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