Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05274802 | A Study of ALS-4 in Healthy Adults Subjects | PHASE1 | COMPLETED | 72 | — | — | Mar 20, 2021 | Jan 2, 2022 | Apr 25, 2022 | 1 | Canada |
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...