ARN-75039 for Lassa Fever

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Arisan Therapeutics, Inc.

Must not be taking: OTC medications, Herbal medications

Disqualifiers: HIV, Drug abuse, Malignancy, others

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any prescription or over-the-counter medications, including supplements and herbal products, at least 7 days before starting the study and throughout the study duration, except for contraceptive medications and limited use of acetaminophen or paracetamol.

Research Team

Ken McCormack, PhD

Principal Investigator

Arisan Therapeutics, Inc.

Eligibility Criteria

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.

Inclusion Criteria

Is male or female, age 18 to 55 years, inclusive, at Screening.

Body mass index (BMI) between 18.5 and 35 kg/m2, inclusive, at Screening.

Hemoglobin, hematocrit, white blood cell count, absolute neutrophil count, and platelet count results within the laboratory reference range at Screening; subjects with Gilbert's disease with associated abnormalities of liver function tests are eligible for enrollment. Tests may be repeated at the discretion of the Investigator to confirm abnormalities.

Exclusion Criteria

Inability to ingest all capsules of a multi-capsule dose within 5 minutes of ingestion of the first capsule.

Positive serology for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) at Screening; subjects with adequately treated HCV are eligible for enrollment.

History of drug or alcohol abuse within 1 year of Screening in the opinion of the investigator, or a positive test for drugs of abuse or alcohol at Screening or Day -1.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose (SAD)

Participants receive escalating single doses of ARN-75039 or placebo to assess safety, tolerability, and pharmacokinetics

6 weeks

Multiple visits for dose administration and monitoring

Multiple Ascending Dose (MAD)

Participants receive escalating multiple doses of ARN-75039 or placebo to assess safety, tolerability, and pharmacokinetics

10 weeks

Multiple visits for dose administration and monitoring

Food Effect (FE)

Selected participants from the SAD cohort are assessed for the effect of food on the bioavailability of ARN-75039

6 weeks

Visits for dose administration under fed and fasted conditions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• ARN-75039 (Other)
• Placebo (Drug)

Trial Overview 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.

Participant Groups

Group I: ARN-75039 Experimental Treatment 1 Intervention

Escalating single or multiple doses of ARN-75039 oral capsules

Group II: Placebo Placebo Group 1 Intervention

Matching placebo capsules in a same SAD and MAD dosing regimen as ARN-75039

Who Is Running the Clinical Trial?

Arisan Therapeutics, Inc.

Lead Sponsor

Trials

1

Recruited

60+

The Defense Threat Reduction Agency (DTRA)

Collaborator

Trials

1

Recruited

60+

Battelle Memorial Institute

Collaborator

Trials

14

Recruited

1,800+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+