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ARN-75039 for Lassa Fever

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.
Awards & highlights

Study Summary

This trial tests the safety, tolerability, and how the body absorbs ARN-75039 in healthy adults over 6 or 10 weeks. 8 subjects in trial to assess food effect.

Eligible Conditions
  • Lassa Fever

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The type and frequency of treatment-emergent adverse events (TEAEs)
Secondary outcome measures
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

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Battelle Memorial InstituteOTHER
11 Previous Clinical Trials
1,689 Total Patients Enrolled
Arisan Therapeutics, Inc.Lead Sponsor
The Defense Threat Reduction Agency (DTRA)UNKNOWN

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals aged 45 and below qualified to participate in this research?

"This medical trial is accessible to those who are 18 years or older and no more than 55."

Answered by AI

Has ARN-75039 been sanctioned by the FDA?

"Our team at Power rated ARN-75039 a score of 1 since the trial is currently in Phase I, meaning there are only small amounts of data analysing its safety and efficacy."

Answered by AI

How many individuals are participating in this clinical experiment?

"Indeed, according to clinicaltrials.gov this trial is still open for recruitment and was initially posted on September 1st 2023. It has been recently updated on February 16th 2023 and requires 64 participants from a single site."

Answered by AI

Are there any open recruitment spots available for this study?

"Affirmative. According to the clinicaltrials.gov, this scientific exploration has been actively recruiting since its inception on September 1st 2023 and is currently in need of 64 individuals from a single location."

Answered by AI

Who is qualified to partake in this clinical investigation?

"The clinical trial is seeking 64 individuals with lassa fever aged between 18 to 55 years of age. The following criteria must be met by applicants: Male or female, BMI between 18.5 and 35 kg/m2, general good health determined during screening tests including medical history assessment, physical examination, 12-lead ECG test results within laboratory reference range at Screening; eGFR based on CKD-EPI equation of ≥ 80 mL/min/1.73 m^2 at Screening for females with childbearing potential a negative pregnancy test result 24 hours prior to dosing study drug as well as FSH ("

Answered by AI
~28 spots leftby Apr 2025