NCT05735249

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Oral ARN-75039 in Healthy Adult Subjects

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 Orally Route in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Arisan Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, and pharmacokinetics (PK) of escalating single ascending dose (SAD) and multiple ascending doses (MAD) of ARN-75039 when administered by the oral route in healthy adult subjects. The SAD portion of the study will enroll approximately 40 subjects for a total duration of 6 weeks. A cohort of 8 subjects in the SAD portion of the study will be selected to assess food effect (including relative bioavailability). The MAD portion of the study will enroll approximately 24 subjects for a total duration of 10 weeks.

Detailed description

This is a randomized, double-blind study of ARN-75039 or placebo given as single and multiple escalating doses in normal healthy subjects. The study will be conducted in three parts: Part 1 will be a Single Ascending Dose (SAD) study enrolling approximately 40 subjects for a total duration of 6 weeks. Part 2 will be a Multiple Ascending Dose (MAD) study enrolling approximately 24 subjects for a total duration of 10 weeks, and part 3 will be a selected SAD cohort in a fasted state to evaluate the effect of food on the bioavailability of ARN-75039, enrolling approximately 8 subjects from a selected SAD cohort for a duration of 6 weeks. The dose escalation will be performed in a step-wise manner. Dose escalation stopping rules will be used to determine whether or not investigation of a higher dose level will proceed per protocol. Safety and tolerability will be assessed by periodic measurement of vital signs, physical examinations, electrocardiograms, blood laboratory analyses and occurrence of adverse events (AE). PK blood samples will be collected at pre-specified time points for noncompartmental data analysis. The PK parameters include but are not limited to: Cmax, Tmax, AUC, CL, and t½. For determination of the food effect, for selected PK parameters (e.g., Cmax, AUC0-τ, and AUC0-∞), comparisons between the fed and fasted conditions will be made.

Conditions

• Lassa Virus Infection

Interventions

Type	Name	Description
DRUG	ARN-75039 oral capsules	SAD: Up to 5 single escalating doses MAD: Up to 3 escalating doses Food-effect: Selected single dose
DRUG	Placebo	Given at frequency and amounts matching ARN- 75039 dosing regimen

Timeline

• Start date: 2023-01-09
• Primary completion: 2025-03-28
• Completion: 2025-03-28
• First posted: 2023-02-21
• Last updated: 2025-05-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study