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A Study to Assess the Safety, Tolerability and Pharmacokinetics of Repeated Dosing Regimens of AL-794 in Healthy Volunteers

NCT03411421 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2025-02-03

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and tolerability (including incidence of central nervous system \[CNS\] related events such as lightheadedness and dizziness), of multiple oral doses of AL-794 in healthy volunteers (HV). Also, to evaluate the pharmacokinetics of ALS-033719 and ALS-033927 in plasma after multiple oral doses of AL-794 in HV.

Conditions

  • Healthy

Interventions

DRUG

AL-794

AL-794 will be administered as tablets orally on Day 1 to Day 5.

DRUG

Placebo

Matching placebo tablets will be administered.

Sponsors & Collaborators

  • Alios Biopharma Inc.

    lead INDUSTRY

Principal Investigators

  • Adeep Puri, MD · Hammersmith Medicines Research

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-03-03
Primary Completion
2018-04-27
Completion
2018-04-27

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT03411421 on ClinicalTrials.gov