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ARN-75039 for Lassa Fever

West Bend, WI
Phase 1
Recruiting
Research Sponsored by Arisan Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 through 14 days post dose for sad cohorts and 28 days post last study dose for mad cohorts.

Summary

This trial tests a new oral drug called ARN-75039 in healthy adults to see if it's safe and how the body handles it. Researchers will measure how much of the drug enters the bloodstream, how long it stays there, and how it's broken down and eliminated.

See full description
Who is the study for?
Healthy adults aged 18-55 with a BMI of 18.5-35 kg/m2 can join this trial. They must have normal blood counts, good overall health, and proper kidney function. Women should use effective contraception and not be pregnant or breastfeeding; men must agree to use condoms. Participants shouldn't have drug/alcohol abuse history, take certain medications, or have serious illnesses.
What is being tested?
The study is testing ARN-75039 oral capsules versus placebo in healthy subjects to see how safe they are and how the body processes them. It includes single ascending doses (SAD) over 6 weeks and multiple ascending doses (MAD) over 10 weeks, with some participants eating food to test its effects on the drug's absorption.See study design
What are the potential side effects?
Potential side effects aren't specified but generally could include digestive discomfort, headaches, allergic reactions or other symptoms related to the medication's action on the body. The study aims to identify these by monitoring participants' health throughout.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 through 14 days post dose for sad cohorts and 28 days post last study dose for mad cohorts.
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 through 14 days post dose for sad cohorts and 28 days post last study dose for mad cohorts. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The type and frequency of treatment-emergent adverse events (TEAEs)
Secondary study objectives
Determination of plasma exposure (AUC0-t, AUC0-inf)
Determination of terminal half life
Determination of the recommended phase 2 dose (RP2D)
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ARN-75039Experimental Treatment1 Intervention
Escalating single or multiple doses of ARN-75039 oral capsules
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo capsules in a same SAD and MAD dosing regimen as ARN-75039

Find a Location

Closest Location:Spaulding Clinical, LLC· West Bend, WI

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

The Defense Threat Reduction Agency (DTRA)UNKNOWN
Battelle Memorial InstituteOTHER
13 Previous Clinical Trials
1,766 Total Patients Enrolled
Arisan Therapeutics, Inc.Lead Sponsor
United States Department of DefenseFED
938 Previous Clinical Trials
338,358 Total Patients Enrolled
Ken McCormack, PhDStudy ChairArisan Therapeutics, Inc.

Media Library

ARN-75039 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05735249 — Phase 1
ARN-75039 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05735249 — Phase 1
Lassa Fever Research Study Groups: Placebo, ARN-75039
Lassa Fever Clinical Trial 2023: ARN-75039 Highlights & Side Effects. Trial Name: NCT05735249 — Phase 1
~20 spots leftby Mar 2026
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