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A Study of ALS-4 in Healthy Adults Subjects

NCT05274802 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2022-04-25

No results posted yet for this study

Summary

A Phase I trial to evaluate the safety, tolerability and Pharmacokinetics of ALS-4 (IM032) in a single ascending dose (SAD) and multiple ascending dose (MAD) in healthy adult subjects.

Conditions

  • Healthy Subject

Interventions

DRUG

ALS-4

Single dose of ALS-4 before Breakfast

DRUG

Placebo

Single dose of placebo before Breakfast

DRUG

ALS-4

Dose three separate times in crossover fashion: (1) fasted morning dose; (2) fed morning dose; (3) fasted evening dose

DRUG

ALS-4

Multiple dose of ALS-4 up to two times daily

DRUG

Placebo

Multiple dose of placebo up to two times daily

Sponsors & Collaborators

  • Aptorum International Limited

    lead INDUSTRY

Principal Investigators

  • Thomas Lee, PhD · Aptorum International Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2021-03-20
Primary Completion
2021-12-22
Completion
2022-01-02

Countries

  • Canada

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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 NCT05274802 on ClinicalTrials.gov