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A Study of AL-034 to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses in Healthy Participants

NCT03285620 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-02-03

No results posted yet for this study

Summary

This is a Phase 1 first-in-human (FIH) study evaluating single and multiple dose administration of AL-034 in healthy adult participants. The aim is to examine the safety (including pharmacodynamic \[PD\] biomarker assessments), tolerability, and pharmacokinetics (PK) of increasing single ascending doses (SADs) (Part 1) and multiple ascending doses (MADs) (Part 2) of AL-034. The potential food effect will be investigated in healthy adult participants at one or optionally 2 single dose level(s).

Conditions

Interventions

DRUG

AL-034

Participants will receive single oral dose of AL-034 under fed or fasted conditions in part 1 and part 2

DRUG

Placebo

Participants will receive single oral dose of matching placebo (oral solution) under fed or fasted conditions in part 1 and part 2.

Sponsors & Collaborators

  • Alios Biopharma Inc.

    lead INDUSTRY

Principal Investigators

  • Alios Biopharma Inc. Clinical Trial · Alios Biopharma Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2017-09-07
Primary Completion
2018-11-14
Completion
2018-11-14

Countries

  • New Zealand

Study Locations

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Entities

Drugs
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 NCT03285620 on ClinicalTrials.gov