At a glance
ClinicalIndex Comparison Record- ✓Age 18 to 55 years at screening
- ✓BMI between 18.5 and 35 kg/m² at screening
- ✓Good general health with no clinically significant findings on medical history, physical exam, ECG, labs, or vital signs
- ✓Hemoglobin, hematocrit, WBC, ANC, and platelet count within normal lab reference range at screening
- ✕Any clinically significant underlying illness
- ✕Prior exposure to ARN-75039
- ✕Positive serology for HBV, HCV, or HIV at screening (treated HCV eligible)
- ✕Positive test for SARS-CoV-2 on Day -1
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Two-Part (SAD and MAD) Study to Assess the Safety, Tolerability, and Pharmacokinetics of ARN-75039 When Administered by the Oral Route in Healthy Adult Subjects.
In Brief
A Phase 1 clinical trial evaluating ARN-75039 oral capsules and Placebo for Healthy Adult Participants. Completed, enrolled 94 participants across 1 site.
Detailed Summary
ARN-75039 is proposed for the treatment of subjects with LASV infection, Lassa hemorrhagic fever, a potentially fatal human disease associated with Lassa viruses, with the most significant unmet medical need. ARN-75039-101 study was a randomized, double-blind, placebo-controlled study that assessed the safety, tolerability, and PK of escalating single and multiple doses of ARN 75039 when administered by the oral route in healthy adult subjects in six single ascending dose (SAD - Part 1) cohorts and five multiple ascending dose (MAD - Part 2) cohorts.
Study Details
Timeline
Interventions
active oral study drug prepared and administered as oral capsules
Given at frequency and amounts matching ARN- 75039 dosing regimen