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

NCT05735249 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2026-05-01

Study results available
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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.

Conditions

  • Healthy Adult Participants

Interventions

DRUG

ARN-75039 oral capsules

active oral study drug prepared and administered as oral capsules

DRUG

Placebo

Given at frequency and amounts matching ARN- 75039 dosing regimen

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Arisan Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Ken McCormack, PhD · Arisan Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-23
Primary Completion
2025-03-28
Completion
2025-03-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05735249 on ClinicalTrials.gov