ARN-75039 for Lassa Fever

Overseen By Ken McCormack, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Arisan Therapeutics, Inc.

Must not be taking: OTC medications, Herbal medications

Disqualifiers: HIV, Drug abuse, Malignancy, others

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment, ARN-75039, to assess its safety and how the body processes it. The goal is to understand its effects when taken in different doses by healthy adults. Participants will receive either the actual treatment or a placebo (a substance with no active drug) for comparison. Ideal candidates are generally healthy adults who can avoid sun exposure for a short period and are comfortable taking multiple capsules quickly. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding how it works in people.

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.

Is there any evidence suggesting that ARN-75039 is likely to be safe for humans?

Research shows that ARN-75039 could help treat arenavirus infections, such as Lassa Fever. Studies suggest that ARN-75039 works effectively against these viruses. However, limited information exists about its safety for humans.

This trial is in its early stages and primarily focuses on the drug's tolerability. In early trials like this, researchers begin with small doses to monitor side effects and gradually increase the amount. This process helps determine the drug's safety and identify potentially excessive doses.

While ARN-75039 appears promising, it remains under testing to ensure its safety for humans. Participants will contribute to understanding its safety and tolerability. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care for Lassa Fever, which typically involves supportive treatment and off-label use of antiviral drugs like ribavirin, ARN-75039 represents a novel approach. Researchers are excited about ARN-75039 because it is administered through escalating oral doses, offering a new delivery method that could enhance patient compliance and convenience. Additionally, ARN-75039 may target the virus more effectively, potentially leading to better outcomes for patients. This innovative approach could be a game-changer in the fight against Lassa Fever.

What evidence suggests that ARN-75039 might be an effective treatment for Lassa Fever?

Research has shown that ARN-75039, which participants in this trial may receive, could help combat Lassa fever by preventing the virus from infecting cells. In animal studies, subjects treated with ARN-75039 survived and recovered from viral infections, unlike those given other treatments or placebos. This suggests ARN-75039 might effectively treat serious viral diseases like Lassa fever. The drug stops the virus from merging with cells, a crucial step for the virus to spread. Early results are promising, but further studies in humans are needed to confirm its effectiveness. ^{1 2 3 4 6}

Who Is on the Research Team?

Ken McCormack, PhD

Principal Investigator

Arisan Therapeutics, Inc.

Are You a Good Fit for This Trial?

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

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.

Females of childbearing potential must practice effective contraception per national regulatory guidelines for clinical trials from Screening, throughout the study and for 28 days after the EOS visit.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• ARN-75039
• Placebo

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8378549/

Potent inhibition of arenavirus infection by a novel fusion ... Additionally, in contrast to surviving mice that received ribavirin or placebo, animals treated with ARN-75039 or ARN-75041 were cured of TCRV infection. In a ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0166354221001157

Potent inhibition of arenavirus infection by a novel fusion ... Taken together, the data strongly support the continued development of ARN-75039 as a candidate therapeutic for the treatment of severe arenaviral diseases.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05735249

NCT05735249 | A Study to Assess the Safety, Tolerability ... 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 ...

4. clinicaltrial.be clinicaltrial.be/en/details/258977?per_page=20&only_recruiting=0&only_eligible=0

A Study to Assess the Safety, Tolerability, and Pharmacok... This is a randomized, double-blind study of ARN-75039 or placebo given as single and multiple escalating doses in normal healthy subjects.

5. cell.com cell.com/cms/10.1016/j.chom.2025.07.020/attachment/9b0758d2-ad78-4532-9718-4db48d5162b9/mmc3.pdf

pH-induced conformational changes and inhibition of the ... In our studies, we make use of ARN-75039, a promising new investigational drug, and furthermore provide the long-desired molecular mecha- nisms ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1931312825002926

pH-induced conformational changes and inhibition of the ... Using the entry inhibitor ARN-75039, we validate our findings and establish the molecular basis for the binding and function of this investigational drug. These ...