Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being studied in healthy adult subjects. It is currently in Phase 1 clinical development, with a completed trial evaluating its safety and tolerability in 72 healthy volunteers in Canada.
ALS-4 is being developed by Aptorum Group Limited, a biopharmaceutical company traded on the stock market under the ticker APM. The company is conducting clinical trials to evaluate the drug's safety and tolerability in healthy subjects.
ALS-4 is in Phase 1 clinical development. The drug is investigational and has not been approved by regulatory authorities. A Phase 1 study in healthy adults has been completed, but the drug remains in early-stage clinical testing.
ALS-4 has one completed clinical trial registered as NCT05274802, titled "A Study of ALS-4 in Healthy Adults Subjects." This Phase 1 study enrolled 72 healthy volunteers in Canada and was a randomized, double-blind, controlled trial.
ALS-4 is not known to have any alternative names. It is a distinct investigational small molecule being developed by Aptorum Group Limited for evaluation in healthy subjects.