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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05735249 | A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Oral ARN-75039 in Healthy Adult Subjects | PHASE1 | COMPLETED | 94 | — | — | Jan 23, 2023 | Mar 28, 2025 | May 1, 2026 | 1 | United States |
A treatment-emergent adverse event (TEAE) was defined as any adverse event that began or worsened after administration of the study drug (ARN-75039 or placebo) through the End-of-Study visit.
Number of participants with at least one treatment-emergent Serious adverse event (TESAE). A TESAE is any adverse event that starts or worsens after administration of study drug (ARN-75039 or placebo).
| Arm | Type | Description |
|---|---|---|
| ARN-75039 oral capsules | EXPERIMENTAL | Escalating single or multiple doses of ARN-75039 oral capsules |
| Placebo (microcrystalline cellulose) | PLACEBO_COMPARATOR | Specified weight of placebo (microcrystalline cellulose) corresponding to the dose of ARN-75039 within the same cohort and encapsulating it in a HPMC capsule prior to dosing. |
| Name | Type | Description |
|---|---|---|
| ARN-75039 oral capsules | DRUG | active oral study drug prepared and administered as oral capsules |
| Placebo | DRUG | Given at frequency and amounts matching ARN- 75039 dosing regimen |
Inclusion Criteria: 1. Is male or female, age 18 to 55 years, inclusive, at Screening. 2. Body mass index (BMI) between 18.5 and 35 kg/m2, inclusive, at Screening. 3. In good general health, determined by no clinically significant findings in the opinion of the Investigator from medical history, ph...