NCT05274802

A Study of ALS-4 in Healthy Adults Subjects

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of ALS-4 (IM032) Administered Orally to Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Aptorum International Limited · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a randomized, double-blind, placebo-controlled, first-in-human (FIH) study of ALS-4 (IM032) in healthy male and non-pregnant, non-lactating female volunteers. The study will consist of two phases: SAD and MAD. The study will evaluate the safety, tolerability and pharmacokinetic (PK) in 6 planned SAD cohorts (5 dose levels, and 1 cohort to evaluate for a potential food or circadian effect) with sentinel design (n=8 per cohort, total randomized 6 active: 2 placebo; sentinel design not applicable when a cohort with the same or a higher drug exposure has already been evaluated) and 3 planned MAD cohorts with sentinel design (n=8 per cohort, total randomized 6 active: 2 placebo).

Conditions

• Healthy Subject

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-03-20
• Primary completion: 2021-12-22
• Completion: 2022-01-02
• First posted: 2022-03-10
• Last updated: 2022-04-25

Locations

1 site across 1 country: Canada