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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07153146 | Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PN-881 in Healthy Subjects. | PHASE1 | RECRUITING | 142 | — | — | Oct 7, 2025 | Jun 15, 2026 | Dec 16, 2025 | 1 | Australia |
Evaluate the safety and tolerability of PN-881 in comparison to placebo after single and multiple doses in healthy subjects assessed for severity, seriousness, and relation to the investigational product.
| Arm | Type | Description |
|---|---|---|
| PN-881 Oral Solution Single Ascending Dose | EXPERIMENTAL | PN-881 Oral Solution Single Ascending Dose |
| Placebo Oral Solution Single Ascending Dose | PLACEBO_COMPARATOR | Placebo single ascending doses |
| PN-881 Oral Solution Multiple Ascending Dose | EXPERIMENTAL | PN-881 Multiple Ascending Doses |
| Placebo Oral Solution Multiple Ascending Dose | PLACEBO_COMPARATOR | Placebo, multiple ascending doses |
| PN-881 Oral Tablet Single Dose | EXPERIMENTAL | PN-881 oral tablet single dose |
| PN-881 Oral Tablet Multiple Dose | EXPERIMENTAL | PN-881 oral tablet multiple dose |
| Name | Type | Description |
|---|---|---|
| PN-881 Oral Solution | DRUG | PN-881 Oral Solution |
| PN-881 Oral Tablet | DRUG | PN-881 oral tablet |
| Placebo | DRUG | Placebo |
Inclusion Criteria: 1. Healthy male and female participants of non-childbearing potential, aged 18-65 years inclusive 2. Body mass index (BMI) between 18 and 32 kg/m² (inclusive) at screening 3. Willing and able to comply with all study requirements and provide written informed consent 4. Male part...