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

NCT05569941 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2023-09-13

No results posted yet for this study

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.

Conditions

Interventions

DRUG

ABI-4334 Tablet

ABI-4334 Tablet

DRUG

ABI-4334 Placebo

Placebo to ABI-4334 Tablet

Sponsors & Collaborators

  • Assembly Biosciences

    lead INDUSTRY

Principal Investigators

  • Edward Gane · New Zealand Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-11-11
Primary Completion
2023-04-12
Completion
2023-04-12

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 NCT05569941 on ClinicalTrials.gov