Healthy Adult ParticipantsPhase 1NCT05735249
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Oral ARN-75039 in Healthy Adult Subjects
A Phase 1 study testing ARN-75039 oral capsules in people with Healthy Adult Participants, run by Arisan Therapeutics, Inc. at 1 site in United States.
Trial summary
ARN-75039 is proposed for the treatment of subjects with LASV infection, Lassa hemorrhagic fever, a potentially fatal human disease associated with Lassa viruses, with the most significant unmet medical need. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants
- What is being tested?
- ARN-75039 oral capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2023to 28 Mar 2025
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- In good general health, determined by no clinically significant findings in the opinion of the Investigator from medical history, physical examination, 12-lead electrocardiogram (ECG), clinical laboratory findings, and vital signs at Screening and Day -1 or 1.
- 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.
- Estimated glomerular filtration rate (eGFR) based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation of ≥ 80 mL/min/1.73m2 at Screening
- 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.
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- Females of childbearing potential must have a negative pregnancy test at Screening and within 24 hours prior to dosing of study drug; for post-menopausal subjects, a blood sample will also be tested for follicle stimulating hormone (FSH) to confirm post-menopausal status (as verified by an FSH of ≥40). Surgically sterile females are eligible; however, proof via medical records will be required.
- Males must agree to not donate sperm and/or to use condoms during sexual intercourse from the time of the first study drug administration and for 90 days following the last dose of study drug, and females must agree not to donate eggs from the time of the first study drug administration and for 60 days following the last dose of study drug.
- Must be Willing and able to comply with measures to avoid photosensitivity reactions (i.e., avoidance of outdoor sun exposure and tanning; consistent use of long sleeve shirts, long pants, hats, and sunglasses; consistent use of SPF 75 or greater sunscreen when outdoors) from Day 1 through Day 8 in Part 1 and through Day 25 in Part 2.
- Able to provide informed consent.
- Willing and able to comply with this protocol and be available for the entire duration of the study.
Who cannot join
- Any clinically significant underlying illness in the opinion of the Investigator.
- Poor venous access.
- Inability to ingest all capsules of a multi-capsule dose within 5 minutes of ingestion of the first capsule.
- Prior exposure to ARN-75039.
- 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.
- Positive test for SARS-CoV-2 infection on Day -1.
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- Consumption of Seville oranges, grapefruit or grapefruit juice within 72 hours prior to Day 1 or during the study.
- 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.
- Use of any prescription or over-the-counter (OTC) medications, including food supplements, vitamins, herbal medications (e.g., St. John's wort), and cannabis, with the exception of contraceptive medications and as needed (prn) acetaminophen or paracetamol (not exceeding 2 grams/day) within 7 days prior to study drug administration and through the EOS visit.
- History of malignancy, except adequately treated basal cell carcinoma or in situ carcinoma of the uterine cervix.
- Smoking greater than 20 cigarettes, cigars, cigarillos or E-cigarettes per week in the 3 months prior to study drug administration or during the study.
- Any female who is pregnant or breastfeeding, or any female who is planning to become pregnant during the study and safety follow-up period.
- Any reason or condition that, in the investigator's opinion, may compromise study participation, present a safety risk to the subject, or may confound the interpretation of the study results.
- A QT duration corrected for heart rate by Fridericia's formula (QTcF) > 450 millisecond (msec) based on either single or averaged QTcF values of triplicate ECGs obtained over a 3-minute interval (at Screening).
- Blood product donation within 30 days before Screening.
- unwilling to consume breakfast and dinner on study drug administration days
- Currently enrolled in another investigational device or drug study, or less than 30 days or 5 half-lives of the prior investigational agent (whichever is longer) or plans to enroll in another investigational device or drug study during the course of this study.
- Part 2 (MAD) only:
- History of:
- Structural abnormality of the gastrointestinal (GI) tract or a disease or history of a condition that can affect GI motility
- Inflammatory bowel disease (even if treated and currently in remission)
- Diverticulitis or any other chronic condition such as chronic pancreatitis, polycystic kidney disease, ovarian cysts, endometriosis, lactose intolerance that was associated with abdominal pain or discomfort and confounded the assessments in this trial.
- Chronic idiopathic diarrhea
- Formally diagnosed with colonic inertia or conditions that were associated with constipation: pseudo-obstruction, colonic inertia, megacolon, megarectum, bowel obstruction, descending perineum syndrome, solitary rectal ulcer syndrome, systemic sclerosis, lower tract evacuation disorders, functional outlet delay (e.g., rectal prolapse, anismus, etc.)
- Current active peptic ulcer disease (i.e., disease that was not adequately treated or stable with therapy.)
- Potential central nervous system cause of constipation (e.g., Parkinson's disease, spinal cord injury, and multiple sclerosis.)
- Subject currently had both unexplained and clinically significant alarm symptoms (lower GI bleeding [rectal bleeding or heme-positive stool], iron-deficiency anemia or any unexplained anemia, or weight loss) or systemic signs of infection or colitis.
- Subjects who did not expel at least 80% (19 or more) of the markers after the Sitzmarks® colonic transit test administered during the screening period.
- History of chronic/generalized pruritus and/or severe skin rash of unknown origin
- Subjects diagnosed with Type 1 or Type 2 diabetes, or with a blood glucose value >125 mg/dL during screening period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Two-Part (SAD and MAD) Study to Assess the Safety, Tolerability, and Pharmacokinetics of ARN-75039 When Administered by the Oral Route in Healthy Adult Subjects.
ARN-75039 is proposed for the treatment of subjects with LASV infection, Lassa hemorrhagic fever, a potentially fatal human disease associated with Lassa viruses, with the most significant unmet medical need. ARN-75039-101 study was a randomized, double-blind, placebo-controlled study that assessed the safety, tolerability, and PK of escalating single and multiple doses of ARN 75039 when administered by the oral route in healthy adult subjects in six single ascending dose (SAD - Part 1) cohorts and five multiple ascending dose (MAD - Part 2) cohorts.
Read the detailed description
In Part 1 (SAD), eight subjects per cohort (except for 10 subjects in cohort 3, evaluating the effects of food) were enrolled to receive the study drug orally in the fed state. Within each cohort of eight subjects, the first two subjects (Sentinel) were randomly assigned in a 1:1 ratio to receive a single dose of ARN-75039 capsules or placebo (microcrystalline cellulose). After the medical monitor reviewed the first 3 days of blinded safety for these subjects, an additional 6 subjects (the remaining cohort) were randomly assigned in a 5:1 (active: placebo) ratio. Within the food-effect cohort of 10 subjects, the first two subjects (Sentinel) were randomly assigned in a 1:1 ratio to receive ARN-75039 capsules or a placebo in the fasted state. After the medical monitor reviewed the first three days of blinded safety for these subjects, an additional 8 subjects (the rest of the cohort) were randomly assigned in a 7:1 (active: placebo) ratio.
The Part 2 (MAD) dosing plan consisted of two days of lead-in doses followed by eight days of maintenance dosing. All doses were administered twice daily (BID), approximately 10 hours apart:
- Day 1: a single dose of ARN-75039 3 times (3×) the maintenance dose, followed by a single dose of 2× the maintenance dose
- Day 2: Two doses of 2× the maintenance dose
- Day 3 through Day 10: BID dosing of the maintenance dose Dose escalation within the SAD and MAD portions was performed after review by the Safety Monitoring Committee (SMC) of blinded safety and available PK data from all subjects in all available cohorts through study Day 8. The MAD part of the study was initiated after the safety and PK data from the SAD part were reviewed by the Food and Drug Administration (FDA), and the Sponsor and FDA determined that it was safe to proceed. The SMC also evaluated the PK profile of ARN-75039, when available, to determine if a threshold exposure associated with potential anti-viral activity was achieved, which corresponded to the recommended Phase 2 dose (RP2D).
The study was conducted in three study periods (Screening Period, Treatment Period, and Follow-up Period). During the Treatment Period, safety was assessed at each study visit, and PK assessments were conducted at specific time points per the assessment schedule. Subjects who received at least one dose of the study drug were instructed and encouraged to complete all study visits. Subjects in the Treatment period had spans of residency at the study site as well as ambulatory periods in each part of the study. Subjects returned to the study site for follow-up evaluations according to the Schedule of Assessments (SOA) during the Treatment Period. After completing the Treatment Period, subjects entered the Safety Follow-up Period, consisting of 14 days for the SAD part of the study and 28 days for the MAD part, culminating in an End-of-study (EOS) visit. For subjects who withdrew from the study prematurely, the EOS visit was conducted within seven days after the last study drug dose.
- Conditions
- Healthy Adult Participants
- Being tested
- ARN-75039 oral capsules, Placebo
- Keywords
- Phase 1, Safety, Tolerability, Randomized, Double-Blind, Single-Ascending Dose, Multiple-Ascending Dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARN-75039 oral capsulesDrug
Also called ARN75039
active oral study drug prepared and administered as oral capsules
PlaceboDrug
Also called Matching placebo oral capsules (Cohorts 1 through 11)
Given at frequency and amounts matching ARN- 75039 dosing regimen
| Study group | Role | What they receive |
|---|---|---|
| ARN-75039 oral capsules | Experimental | Escalating single or multiple doses of ARN-75039 oral capsules Receives: Drug: ARN-75039 oral capsules |
| Placebo (microcrystalline cellulose) | Placebo comparator | Specified weight of placebo (microcrystalline cellulose) corresponding to the dose of ARN-75039 within the same cohort and encapsulating it in a HPMC capsule prior to dosing. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events (TEAEs)
A treatment-emergent adverse event (TEAE) was defined as any adverse event that began or worsened after administration of the study drug (ARN-75039 or placebo) through the End-of-Study visit.
Measured: From first dose through the End-of-Study (EOS) visit: Part 1 (SAD), through Day 15/EOS; Food-effect cohort, through the second treatment period and Day 29/EOS; Part 2 (MAD), from Day 1 through Day 39/EOS.
Incidence of Treatment-Emergent Serious Adverse Events (TESAEs)
Number of participants with at least one treatment-emergent Serious adverse event (TESAE). A TESAE is any adverse event that starts or worsens after administration of study drug (ARN-75039 or placebo).
Measured: From first dose through the End-of-Study (EOS) visit: Part 1 (SAD), through Day 15/EOS; Food-effect cohort, through the second treatment period and Day 29/EOS; Part 2 (MAD), from Day 1 through Day 39/EOS.
Secondary outcomes (7)
Part 1-SAD: Cmax
Maximum Observed Plasma Concentrations of ARN-75039 (Cmax); Pharmacokinetic endpoints included standard noncompartmental parameters following single and multiple ascending oral doses of ARN-75039. The effect of food on ARN-75039 pharmacokinetics was evaluated following administration under fed and fasted conditions. Integrated safety and PK data were used to determine the recommended Phase 2 dose (RP2D) and dosing regimen.
Measured: Day 1 predose and at 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 12, 24 (Day 2), 48 (Day 3), 72 (Day 4), 168 (Day 8), and 336 (Day 15/EOS) hours postdose.
Part 1-SAD: Tmax
PK of ARN-75039 in healthy subjects as assessed by time to reach Cmax (Tmax) towards the determination of the optimal PK dose
Measured: Day 1 predose and at 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 12, 24 (Day 2), 48 (Day 3), 72 (Day 4), 168 (Day 8), and 336 (Day 15/EOS) hours postdose.
Part 1-SAD: Terminal Half-life
PK of ARN-75039 in healthy subjects as assessed by terminal elimination half-life (T1/2)
Measured: Derived from plasma samples collected from Day 1 predose through 336 hours (Day 15/EOS) postdose.
Part 1-SAD: AUC
PK of ARN-75039 in healthy subjects as assessed by plasma exposure (AUC), determination of the optimal PK dose
Measured: Day 1 predose and at 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 12, 24 (Day 2), 48 (Day 3), 72 (Day 4), 168 (Day 8), and 336 (Day 15/EOS) hours postdose.
Part 2-MAD: Cmax0-10h
Maximum Plasma Concentrations of ARN-75039 at 1 and 10 days. Pharmacokinetic endpoints included standard noncompartmental parameters following single and multiple ascending oral doses of ARN-75039. The effect of food on ARN-75039 pharmacokinetics was evaluated following administration under fed and fasted conditions. Integrated safety and PK data were used to determine the recommended Phase 2 dose (RP2D) and dosing regimen
Measured: Day 1 and Day 10: predose and at 0.5, 1, 2, 4, 6, 8, and 10 hours after the morning dose.
Part 2-MAD: Tmax0-10h.
Time to maximum ARN-75039 concentration. Pharmacokinetic endpoints included standard noncompartmental parameters following single and multiple ascending oral doses of ARN-75039. The effect of food on ARN-75039 pharmacokinetics was evaluated following administration under fed and fasted conditions. Integrated safety and PK data were used to determine the recommended Phase 2 dose (RP2D) and dosing regimen.
Measured: Day 1 and Day 10: predose and at 0.5, 1, 2, 4, 6, 8, and 10 hours after the morning dose.
Part 2-MAD: AUC0-10h
Area Under the Concentration Time Profile. Pharmacokinetic endpoints included standard noncompartmental parameters following single and multiple ascending oral doses of ARN-75039. The effect of food on ARN-75039 pharmacokinetics was evaluated following administration under fed and fasted conditions. Integrated safety and PK data were used to determine the recommended Phase 2 dose (RP2D) and dosing regimen.
Measured: Day 1 and Day 10: predose and at 0.5, 1, 2, 4, 6, 8, and 10 hours after the morning dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start23 Jan 2023
- Primary completion28 Mar 2025
- Study completion28 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy Adult ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This is a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, and PK of escalating single and multiple doses of ARN-75039 when administered by the oral route in healthy adult subjects. Six single ascending dose (SAD) cohorts and five multiple ascending dose (MAD) cohorts, with approximately 8 subjects per cohort, will be enrolled to receive study drug or placebo. Within each cohort, the first 2 subjects will be randomized 1:1 to receive ARN-75039 capsules or placebo. After a review of the first 3 days of blinded safety for these subjects by the Medical Monitor, an additional 6 subjects were randomized in a 5:1 (active: placebo) ratio. Each subsequent dose escalation was based on safety data review of the current dose level.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arisan Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Ken McCormack, PhD, Study chair, Arisan Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05735249
- Sponsor's protocol ID
- ARN-75039-101
- Status last verified
- Feb 2026
- First submitted
- 27 Jan 2023
- Last updated
- 1 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Two-Part (SAD and MAD) Study to Assess the Safety, Tolerability, and Pharmacokinetics of ARN-75039 When Administered by the Oral Route in Healthy Adult Subjects.
- ClinicalTrials.gov ID
- NCT05735249
- Acronym / sponsor ID
- ARN-75039-101
- Conditions
- Healthy Adult Participants
- Keywords
- Phase 1, Safety, Tolerability, Randomized, Double-Blind, Single-Ascending Dose, Multiple-Ascending Dose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Arisan Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 28 Mar 2025 (actual)
- Study completion
- 28 Mar 2025 (actual)
- First posted
- 21 Feb 2023 (actual)
- Results
- Posted 1 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
ARN-75039 is proposed for the treatment of subjects with LASV infection, Lassa hemorrhagic fever, a potentially fatal human disease associated with Lassa viruses, with the most significant unmet medical need. ARN-75039-101 study was a randomized, double-blind, placebo-controlled study that assessed the safety, tolerability, and PK of escalating single and multiple doses of ARN 75039 when administered by the oral route in healthy adult subjects in six single ascending dose (SAD - Part 1) cohorts and five multiple ascending dose (MAD - Part 2) cohorts.
Detailed description
In Part 1 (SAD), eight subjects per cohort (except for 10 subjects in cohort 3, evaluating the effects of food) were enrolled to receive the study drug orally in the fed state. Within each cohort of eight subjects, the first two subjects (Sentinel) were randomly assigned in a 1:1 ratio to receive a single dose of ARN-75039 capsules or placebo (microcrystalline cellulose). After the medical monitor reviewed the first 3 days of blinded safety for these subjects, an additional 6 subjects (the remaining cohort) were randomly assigned in a 5:1 (active: placebo) ratio. Within the food-effect cohort of 10 subjects, the first two subjects (Sentinel) were randomly assigned in a 1:1 ratio to receive ARN-75039 capsules or a placebo in the fasted state. After the medical monitor reviewed the first three days of blinded safety for these subjects, an additional 8 subjects (the rest of the cohort) were randomly assigned in a 7:1 (active: placebo) ratio.
The Part 2 (MAD) dosing plan consisted of two days of lead-in doses followed by eight days of maintenance dosing. All doses were administered twice daily (BID), approximately 10 hours apart:
- Day 1: a single dose of ARN-75039 3 times (3×) the maintenance dose, followed by a single dose of 2× the maintenance dose
- Day 2: Two doses of 2× the maintenance dose
- Day 3 through Day 10: BID dosing of the maintenance dose Dose escalation within the SAD and MAD portions was performed after review by the Safety Monitoring Committee (SMC) of blinded safety and available PK data from all subjects in all available cohorts through study Day 8. The MAD part of the study was initiated after the safety and PK data from the SAD part were reviewed by the Food and Drug Administration (FDA), and the Sponsor and FDA determined that it was safe to proceed. The SMC also evaluated the PK profile of ARN-75039, when available, to determine if a threshold exposure associated with potential anti-viral activity was achieved, which corresponded to the recommended Phase 2 dose (RP2D).
The study was conducted in three study periods (Screening Period, Treatment Period, and Follow-up Period). During the Treatment Period, safety was assessed at each study visit, and PK assessments were conducted at specific time points per the assessment schedule. Subjects who received at least one dose of the study drug were instructed and encouraged to complete all study visits. Subjects in the Treatment period had spans of residency at the study site as well as ambulatory periods in each part of the study. Subjects returned to the study site for follow-up evaluations according to the Schedule of Assessments (SOA) during the Treatment Period. After completing the Treatment Period, subjects entered the Safety Follow-up Period, consisting of 14 days for the SAD part of the study and 28 days for the MAD part, culminating in an End-of-study (EOS) visit. For subjects who withdrew from the study prematurely, the EOS visit was conducted within seven days after the last study drug dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, and PK of escalating single and multiple doses of ARN-75039 when administered by the oral route in healthy adult subjects. Six single ascending dose (SAD) cohorts and five multiple ascending dose (MAD) cohorts, with approximately 8 subjects per cohort, will be enrolled to receive study drug or placebo. Within each cohort, the first 2 subjects will be randomized 1:1 to receive ARN-75039 capsules or placebo. After a review of the first 3 days of blinded safety for these subjects by the Medical Monitor, an additional 6 subjects were randomized in a 5:1 (active: placebo) ratio. Each subsequent dose escalation was based on safety data review of the current dose level.
| Arm | Type | Receives |
|---|---|---|
| ARN-75039 oral capsules | Experimental | Drug: ARN-75039 oral capsulesEscalating single or multiple doses of ARN-75039 oral capsules |
| Placebo (microcrystalline cellulose) | Placebo comparator | Drug: PlaceboSpecified weight of placebo (microcrystalline cellulose) corresponding to the dose of ARN-75039 within the same cohort and encapsulating it in a HPMC capsule prior to dosing. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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.
- In good general health, determined by no clinically significant findings in the opinion of the Investigator from medical history, physical examination, 12-lead electrocardiogram (ECG), clinical laboratory findings, and vital signs at Screening and Day -1 or 1.
- 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.
- Estimated glomerular filtration rate (eGFR) based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation of ≥ 80 mL/min/1.73m2 at Screening
Key exclusion criteria (30 listed)
- Any clinically significant underlying illness in the opinion of the Investigator.
- Poor venous access.
- Inability to ingest all capsules of a multi-capsule dose within 5 minutes of ingestion of the first capsule.
- Prior exposure to ARN-75039.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARN-75039 oral capsulesAlso: ARN75039active oral study drug prepared and administered as oral capsules | Drug | ARN-75039 oral capsules |
| PlaceboAlso: Matching placebo oral capsules (Cohorts 1 through 11)Given at frequency and amounts matching ARN- 75039 dosing regimen | Drug | Placebo (microcrystalline cellulose) |
Primary outcome
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: From first dose through the End-of-Study (EOS) visit: Part 1 (SAD), through Day 15/EOS; Food-effect cohort, through the second treatment period and Day 29/EOS; Part 2 (MAD), from Day 1 through Day 39/EOS.
A treatment-emergent adverse event (TEAE) was defined as any adverse event that began or worsened after administration of the study drug (ARN-75039 or placebo) through the End-of-Study visit.
Incidence of Treatment-Emergent Serious Adverse Events (TESAEs)
Time frame: From first dose through the End-of-Study (EOS) visit: Part 1 (SAD), through Day 15/EOS; Food-effect cohort, through the second treatment period and Day 29/EOS; Part 2 (MAD), from Day 1 through Day 39/EOS.
Number of participants with at least one treatment-emergent Serious adverse event (TESAE). A TESAE is any adverse event that starts or worsens after administration of study drug (ARN-75039 or placebo).
7 secondary outcomes
Part 1-SAD: Cmax
Time frame: Day 1 predose and at 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 12, 24 (Day 2), 48 (Day 3), 72 (Day 4), 168 (Day 8), and 336 (Day 15/EOS) hours postdose.
Part 1-SAD: Tmax
Time frame: Day 1 predose and at 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 12, 24 (Day 2), 48 (Day 3), 72 (Day 4), 168 (Day 8), and 336 (Day 15/EOS) hours postdose.
Part 1-SAD: Terminal Half-life
Time frame: Derived from plasma samples collected from Day 1 predose through 336 hours (Day 15/EOS) postdose.
Part 1-SAD: AUC
Time frame: Day 1 predose and at 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 12, 24 (Day 2), 48 (Day 3), 72 (Day 4), 168 (Day 8), and 336 (Day 15/EOS) hours postdose.
Part 2-MAD: Cmax0-10h
Time frame: Day 1 and Day 10: predose and at 0.5, 1, 2, 4, 6, 8, and 10 hours after the morning dose.
Part 2-MAD: Tmax0-10h.
Time frame: Day 1 and Day 10: predose and at 0.5, 1, 2, 4, 6, 8, and 10 hours after the morning dose.
Part 2-MAD: AUC0-10h
Time frame: Day 1 and Day 10: predose and at 0.5, 1, 2, 4, 6, 8, and 10 hours after the morning dose.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ken McCormack, PhD study chair
Arisan Therapeutics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ARN-75039 oral capsules in people with Healthy Adult Participants, run by Arisan Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (TEAEs) (time frame: From first dose through the End-of-Study (EOS) visit: Part 1 (SAD), through Day 15/EOS; Food-effect cohort, through the second treatment period and Day 29/EOS; Part 2 (MAD), from Day 1 through Day 39/EOS.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.