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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04621630 | Pharmacokinetics of PN-235 in Healthy Volunteers | PHASE1 | COMPLETED | 107 | — | — | Nov 12, 2020 | Oct 13, 2021 | Feb 18, 2022 | 1 | Australia |
Number and severity of Adverse Events
| Arm | Type | Description |
|---|---|---|
| Single Dose | EXPERIMENTAL | Single dose administration |
| Multiple Dose | EXPERIMENTAL | Multiple dose administration |
| Solid Dose Comparison | EXPERIMENTAL | Solid dose administartion |
| Name | Type | Description |
|---|---|---|
| PN-235 | DRUG | Active Drug |
| Placebo | DRUG | Matching Placebo |
Key Inclusion Criteria: * Subjects must have BMI between 18 and 32 * Subjects must be non-smokers or social smokers * Subjects must comply with contraception requirements * Subjects must be willing to consume meals provided by the clinical center Key Exclusion Criteria: * Subject must not have hi...