A Study of ALS-4 in Healthy Adults Subjects

Status Completed

Clinical Trial 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.

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Healthy Subject

Clinical Trial Details

NCT number	NCT05274802
Study type	Interventional
Source	Aptorum International Limited
Contact
Status	Completed
Phase	Phase 1
Start date	March 20, 2021
Completion date	January 2, 2022

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