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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABI-H3733 in Healthy Adults

NCT04271592 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-01-27

No results posted yet for this study

Summary

This study is designed to assess safety, tolerability, pharmacokinetics (PK), formulation (liquid and solid oral forms) and food effect of ABI-H3733 in healthy participants. Part 1 includes evaluation of the safety, tolerability, and PK of ABI-H3733 during single ascending dose (SAD) and multiple-ascending dose (MAD) administration of the oral liquid formulation. Part 2 includes assessment of a solid dosage formulation of ABI-H3733 in participants under fasted conditions or after a high-fat meal. Optional cohorts may be enrolled in Parts 1 and 2 of the study to explore additional dose levels, solid oral dosage formulations, or for cohort expansion.

Conditions

Interventions

DRUG

ABI-H3733 Liquid Oral Dosage Form

ABI-H3733 liquid oral dosage form

DRUG

ABI-H3733 Solid Oral Dosage Form

ABI-H3733 solid oral dosage form

DRUG

Placebo to ABI-H3733 Liquid Oral Dosage Form

Placebo to ABI-H3733 liquid oral dosage form

DRUG

Placebo to ABI-H3733 Solid Oral Dosage Form

Placebo to ABI-H3733 solid oral dosage form

Sponsors & Collaborators

  • Assembly Biosciences

    lead INDUSTRY

Principal Investigators

  • Katia Alves, MD · Assembly Biosciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-05-17
Primary Completion
2020-11-03
Completion
2021-01-14
FDA Drug
Yes

Countries

  • New Zealand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04271592 on ClinicalTrials.gov