ARN-75039 for Lassa Fever

Overseen By Peter VanWie, PhD, MPH

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Arisan Therapeutics, Inc.

Must not be taking: OTC medications, Herbal medications

Disqualifiers: Drug abuse, Diabetes, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 15 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, ARN-75039, for safety and how the body processes it. Participants will assist researchers in comparing two forms of the treatment—one in a capsule and one in a tablet. Healthy adults who are not currently taking medications, have no significant health issues, and can commit to staying at the study site for several days might be suitable candidates. 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 the study starts and until the Day 15 Discharge visit, except for contraceptive medications and limited use of acetaminophen.

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

Research has shown that ARN-75039 has been promising in early studies. In animal tests, those treated with ARN-75039 survived and recovered from viral infections, unlike those given other treatments or placebos. This suggests the treatment could be effective and safe.

Other studies with healthy people tested single and multiple doses of ARN-75039. The results supported its continued development, with no major safety issues reported. These findings suggest that ARN-75039 is generally well-tolerated in humans.

It is important to know that this trial is in its early phase. Researchers are still learning about its safety and how the body processes the treatment. Participants in the trial will be closely monitored for any side effects. This careful monitoring helps ensure that any issues are quickly addressed. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for Lassa Fever, which typically involve supportive care and antiviral drugs like ribavirin, ARN-75039 introduces a novel approach with its unique formulation. This investigational drug stands out due to its new delivery methods: neat ARN-75039 in HPMC capsules and ARN-75039 with excipients in tablet form, which may improve absorption and effectiveness. Researchers are excited about ARN-75039 because it could potentially offer a more efficient way to combat the virus, providing a faster or more robust response compared to existing options.

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

Studies have shown that ARN-75039 is a promising treatment for arenavirus infections, such as Lassa fever. In animal studies, those treated with ARN-75039 survived and recovered from the virus, unlike those given other treatments or placebos. Research suggests that ARN-75039 prevents the virus from entering cells, stopping the infection from spreading. These results strongly support further development of ARN-75039 for treating severe arenaviral diseases. Although information from human studies remains limited, early findings are encouraging for its potential use in treating Lassa fever. Participants in this trial will receive ARN-75039 in different formulations to evaluate its effectiveness and safety. ^{1 2 3 4 5}

Who Is on the Research Team?

Ken McCormack, PhD

Principal Investigator

Arisan Therapeutics

Are You a Good Fit for This Trial?

Healthy adults can join this study to compare two forms of a drug for Lassa fever. Participants will take ARN-75039 in capsule or tablet form after eating, stay at the study site for about 2 weeks, and have regular health checks.

Inclusion Criteria

Body mass index (BMI) between 18 and 35 kg/m2, inclusive, at Screening

Negative pregnancy test for females at Screening and within 24 hours prior to dosing of study drug

Compliance with measures to avoid photosensitivity reactions

Exclusion Criteria

Any clinically significant underlying illness

History of drug or alcohol abuse within 1 year of Screening

Pregnant, breastfeeding, or planning pregnancy during the study period

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 3 weeks

Admission to Study Site

Participants are admitted to the study site on Day -1 and remain until Day 15 for the treatment period

16 days

Continuous stay at the study site

Treatment

Participants receive study drug on Day 1 and Day 8 with a 7-day washout period between doses

15 days

2 treatment days with continuous monitoring

End of Active Treatment

Participants complete safety assessments and are discharged on Day 15

1 day

Discharge visit

Follow-up

Participants are contacted by phone on Day 36 to assess for any adverse events

28 days

1 telephone follow-up

What Are the Treatments Tested in This Trial?

Interventions

• ARN-75039

Trial Overview The trial tests how the body processes ARN-75039 when taken as a neat capsule versus with excipients in tablet form. It's randomized and crossover, meaning participants try both forms with a week break in between.

How Is the Trial Designed?

Group I: Sequence 2 Experimental Treatment 1 Intervention

In Sequence 2, study participants are dosed with ARN-75039 with excipients in tablet form (comparator product) on Day 1 of Period 1. After a 7 day washout period, study participants are dosed with neat ARN-75039 in HPMC capsules (reference product).

Group II: Sequence 1 Experimental Treatment 1 Intervention

In Sequence 1, study participants are dosed with neat ARN-75039 in HPMC capsules (reference product) on Day 1 of Period 1. After a 7 day washout period, study participants are dosed with ARN-75039 with excipients in tablet form (comparator product) on Day 1 of Period 2.

Who Is Running the Clinical Trial?

Arisan Therapeutics, Inc.

Lead Sponsor

Trials

1

Recruited

60+

Citations

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

Potent inhibition of arenavirus infection by a novel fusion ... Thus, regardless of survival outcome beyond the acute infection, mice treated with ARN-75039 or ARN-75041 were cleared of the TCRV infection. In contrast, ...

2. 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 ...

3. 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.

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. withpower.com withpower.com/trial/phase-1-lassa-fever-2023-8d18f

ARN-75039 for Lassa Fever · Info for Participants In animal studies, subjects treated with ARN-75039 survived and recovered from viral infections, unlike those given other treatments or placebos.