Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as IM032
ALS-4 · 1 trial · 1 indication
An adverse event is any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding, for example), symptom, or disease temporally associated with the Study or use of investigational drug product, whether or not the AE is considered related to the investigational drug product.
| Arm | Type | Description |
|---|---|---|
| Part A1 (Single dose): Cohort A: ALS-4 25mg | EXPERIMENTAL | Single dose of ALS-4 or placebo before Breakfast |
| Part A1 (Single dose): Cohort B: ALS-4 50mg | EXPERIMENTAL | Single dose of ALS-4 or placebo before Breakfast |
| Part A1 (Single dose): Cohort C: ALS-4 100mg | EXPERIMENTAL | Single dose of ALS-4 or placebo before Breakfast |
| Part A1 (Single dose): Cohort D: ALS-4 200mg | EXPERIMENTAL | Single dose of ALS-4 or placebo before Breakfast |
| Part A1 (Single dose): Cohort E: ALS-4 300mg | EXPERIMENTAL | Single dose of ALS-4 or placebo before Breakfast |
| Part A2 (Single dose): Cohort F: ALS-4 50mg | EXPERIMENTAL | Dose three separate times in crossover fashion: (1) fasted morning dose; (2) fed morning dose; (3) fasted evening dose |
| Part B (Multiple dose): Cohort AA: ALS-4 50mg | EXPERIMENTAL | Multiple dose of ALS-4 or placebo up to two times daily |
| Part B (Multiple dose): Cohort BB: ALS-4 100mg | EXPERIMENTAL | Multiple dose of ALS-4 or placebo up to two times daily |
| Part B (Multiple dose): Cohort CC: ALS-4 200mg | EXPERIMENTAL | Multiple dose of ALS-4 or placebo up to two times daily |
| Name | Type | Description |
|---|---|---|
| ALS-4 | DRUG | Single dose of ALS-4 before Breakfast |
| Placebo | DRUG | Single dose of placebo before Breakfast |
Inclusion Criteria: * Healthy, non-smoking male and female volunteers (18-60 years inclusive at the time of informed consent.) * Body mass index (BMI) within 18.5 - 33.0 kg/m2 inclusive and weight \>50 kg. * Healthy, according to the medical history, ECG, vital signs, laboratory results and physica...
ALS-4 is an investigational small molecule developed by Aptorum Group Limited. It has been studied in a Phase 1 clinical trial in healthy adult volunteers, and no therapeutic indication for the drug has been disclosed. It is not an approved medicine and remains in clinical development.
ALS-4 is being developed by Aptorum Group Limited, which trades under the ticker APM. The company sponsored the Phase 1 study of the compound in healthy adult subjects.
ALS-4 is in Phase 1 development. A single Phase 1 trial has been conducted, and that study is now completed. The drug is investigational and has not been approved for any use.
ALS-4 has been evaluated in one clinical trial, NCT05274802, titled A Study of ALS-4 in Healthy Adults Subjects. The Phase 1 study enrolled 72 participants in Canada, was randomized, double blind, and controlled, and it is now completed.
Yes. The Phase 1 trial of ALS-4, NCT05274802, was a randomized, double blind, controlled study. It enrolled 72 healthy adult volunteers of any sex, aged 18 years and older, at sites in Canada, and the study has been completed.