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A First in Human Study to Assess Safety, Tolerability, Pharmacokinetics of ABI-4334 in Healthy Subjects

Sponsor
Assembly Biosciences (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05569941
Collaborator
(none)
62
Enrollment
6
Arms
4.4
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This study is designed to assess safety, tolerability, and PK of single ascending doses (SAD) of ABI-4334 in Part A and multiple-ascending doses (MAD) of ABI-4334 in Part B in healthy subjects. Effect of food will also be evaluated in Part A.

Condition or Disease Intervention/Treatment Phase
  • Drug: ABI-4334 Tablet
  • Drug: ABI-4334 Placebo
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
62 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 1, Blinded, Placebo-Controlled Study of the Safety, Tolerability, Pharmacokinetics of Single and Multiple Ascending Doses of ABI-4334 in Healthy Subjects
Anticipated Study Start Date :
Nov 7, 2022
Anticipated Primary Completion Date :
Mar 13, 2023
Anticipated Study Completion Date :
Mar 20, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: ABI-4334 Tablet
ABI-4334 Tablet
Placebo Comparator: Part A: SAD Cohorts 1-5 ABI-4334 Placebo Tablet

A single dose of placebo matching ABI-4334 will be administered on Day 1.

Drug: ABI-4334 Placebo
Placebo to ABI-4334 Tablet
Experimental: 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.

Drug: ABI-4334 Tablet
ABI-4334 Tablet
Placebo Comparator: 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.

Drug: ABI-4334 Placebo
Placebo to ABI-4334 Tablet
Experimental: 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.

Drug: ABI-4334 Tablet
ABI-4334 Tablet
Placebo Comparator: 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.

Drug: ABI-4334 Placebo
Placebo to ABI-4334 Tablet

Outcome Measures

Primary Outcome Measures

  1. Proportion of subjects with adverse events (AEs), premature treatment discontinuation due to AEs, and abnormal laboratory results [Up to Day 14]

Secondary Outcome Measures

  1. SAD Cohorts 1-7: Area Under the Plasma Concentration Time Curve (AUC) of ABI-4334 [before and at pre-specified time points up to 144 hours after dosing]

  2. SAD Cohorts 1-7: Maximum Observed Plasma Concentration (Cmax) of ABI-4334 [before and at pre-specified time points up to 144 hours after dosing]

  3. SAD Cohorts 1-7: Time to Cmax (Tmax) of ABI-4334 [before and at pre-specified time points up to 144 hours after dosing]

  4. SAD Cohorts 1-7: Apparent Terminal Elimination Half Life (t 1/2) of ABI-4334 [before and at pre-specified time points up to 144 hours after dosing]

  5. SAD Cohorts 1-7: Apparent Systemic Clearance (CL/F) of ABI-4334 [before and at pre-specified time points up to 144 hours after dosing]

  6. SAD Cohorts 1-7: Apparent Volume of Distribution (Vz/F) of ABI-4334 [before and at pre-specified time points up to 144 hours after dosing]

  7. SAD Cohorts 1-7: Comparison of Cmax between fasted and fed treatments of ABI-4334 [before and at pre-specified time points up to 144 hours after dosing]

  8. SAD Cohorts 1-7: Comparison of AUC between fasted and fed treatments of ABI-4334 [before and at pre-specified time points up to 144 hours after dosing]

  9. MAD Cohorts 1-2: AUC of ABI-4334 [before and at pre-specified time points up to 24 hours after dosing on Day 1; before dosing on days 2-7; before and up to 120 hours after dosing on Day 8]

  10. MAD Cohorts 1-2: Cmax of ABI-4334 [before and at pre-specified time points up to 24 hours after dosing on Day 1; before dosing on days 2-7; before and up to 120 hours after dosing on Day 8]

  11. MAD Cohorts 1-2: Tmax of ABI-4334 [before and at pre-specified time points up to 24 hours after dosing on Day 1; before dosing on days 2-7; before and up to 120 hours after dosing on Day 8]

  12. MAD Cohorts 1-2: t 1/2 of ABI-4334 [before and at pre-specified time points up to 24 hours after dosing on Day 1; before dosing on days 2-7; before and up to 120 hours after dosing on Day 8]

  13. MAD Cohorts 1-2: CL/F of ABI-4334 [before and at pre-specified time points up to 24 hours after dosing on Day 1; before dosing on days 2-7; before and up to 120 hours after dosing on Day 8]

  14. MAD Cohorts 1-2: Vz/F of ABI-4334 [before and at pre-specified time points up to 24 hours after dosing on Day 1; before dosing on days 2-7; before and up to 120 hours after dosing on Day 8]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Body mass index (BMI) between 18.0 and 30.0 kg/m2

  • 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:

  • Positive results for any of the following serology tests, HBsAg, hepatitis B core antibody (HBcAb IgM), hepatitis C virus antibody (HCV Ab), or HIV-1 or -2 antibody

  • 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assembly Biosciences

Investigators

  • Principal Investigator: Edward Gane, New Zealand Clinical Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assembly Biosciences
ClinicalTrials.gov Identifier:
NCT05569941
Other Study ID Numbers:
  • ABI-4334-101
First Posted:
Oct 6, 2022
Last Update Posted:
Oct 6, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Assembly Biosciences
ABI-4334
PK
Healthy Subjects
Additional relevant MeSH terms:
Hepatitis B
Hepatitis B, Chronic

Study Results

No Results Posted as of Oct 6, 2022