Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
YJ001 for Use · 1 trial · 1 indication
If ≥ 2 subjects assigned to YJ001 in a cohort experience any of the following: 1. A Grade ≥ 2 adverse event. 2. A Grade ≥ 2 clinically significant laboratory abnormality.
If ≥ 1 subject meets/exceeds the exposure limits for any of YJ001 and its metabolites (YJ001-A, YJ001-B, and/or YJ001-C) or if subjects are expected to exceed the specific exposure limits for any analyte at a next planned dose level.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 (6 active, 2 placebo) | EXPERIMENTAL | 148 mg |
| Cohort 2 (6 active, 2 placebo) | EXPERIMENTAL | 296 mg |
| Cohort 3 (6 active, 2 placebo) | EXPERIMENTAL | 552 mg |
| Cohort 4 (6 active, 2 placebo) | EXPERIMENTAL | 828 mg |
| Name | Type | Description |
|---|---|---|
| YJ001 for Spray Use | DRUG | YJ001 (active ingredient) |
| Placebo of YJ001 for Spray Use | DRUG | Hydroxypropyl Methylcellulose |
Inclusion Criteria: 1. Male or female, between the ages of 18-55 years at screening, both inclusive. 2. Subjects voluntarily consenting for participation in the study and have signed informed consent document. Subjects are required to understand verbal and/or written English or any other language i...
YJ001 is an investigational small molecule being studied for safety and tolerability. It is currently in Phase 1 clinical development, with a completed single-ascending dose trial in healthy volunteers. The drug is not yet approved and remains under investigation.
YJ001 is being developed by BrainsWay Ltd., a company traded under the ticker BWAY. The developer is responsible for advancing the drug through clinical trials.
YJ001 is in Phase 1 clinical development. One Phase 1 trial has been completed, and the drug is still investigational. It has not received regulatory approval and remains in early-stage testing.
YJ001 has one completed clinical trial, NCT05451667, a single-ascending dose study assessing safety, tolerability, and pharmacokinetics in healthy volunteers. The trial enrolled 32 participants in the United States and was randomized, double-blind, and controlled.
YJ001 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trial focused on safety and tolerability in healthy volunteers, and further studies are needed before any approval consideration.