RecruitingPhase 1ACTRN12622001300763

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Properties of iN1011-N17 after Oral Administration in Healthy Volunteers and Post-Herpetic Neuralgia (PHN) Patients

A Randomized, Double-blind, Placebo-controlled, Multiple-Ascending Dose Phase 1b Study to Evaluate the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Properties of iN1011-N17 after Oral Administration in Healthy Volunteers and Post-Herpetic Neuralgia Patients and to Assess the Relative Bioavailability of Mesylate vs Hydrochloride Salt Capsules in Healthy Volunteers

Sponsor

iN Therapeutics Co., Ltd.

Enrollment

32 participants

Start Date

Aug 24, 2022

Study Type

Interventional

Conditions

Post Hepatic Neuralgia

Summary

This study is a prospective, randomized, double-blind, placebo-controlled, Phase 1b clinical study to evaluate the safety, tolerability, PK, and PD of oral multiple-ascending doses (MAD) of iN1011-N17 after Oral Administration in Healthy Volunteers and OsteoarthritisPost-Herpetic Neuralgia Patients and to Assess the Relative Bioavailability of Mesylate vs Hydrochloride Salt Capsules in Healthy Volunteers. The study will be conducted with approximately in 3 parts. 56 healthy volunteers and 8 PHP patients will enrolled in up to 8 sequential MAD dose cohorts (Cohorts 1 to 8), each cohort can commence after the corresponding dose cohort has been completed and after Safety Review Committee (SRC) approval.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 55 Yearss

Plain Language Summary

Simplified for easier understanding

Post-herpetic neuralgia is a type of persistent nerve pain that can remain for months or even years after a shingles infection. It can be debilitating, with burning, stabbing, or electric-shock sensations that are hard to treat with existing medications. Researchers are investigating a new oral drug called iN1011-N17 to see if it can safely and effectively address this type of nerve pain. This early-phase clinical trial is testing increasing doses of the drug in both healthy volunteers and patients with post-herpetic neuralgia to understand how the body processes it, how safe it is, and whether it shows early signs of effectiveness. Different formulations of the drug (two different salt forms) are also being compared to see which is absorbed better. You may be eligible as a healthy volunteer if you are aged 18 to 55, in generally good health with a BMI between 18 and 32, and are not taking prescription medications. People with significant medical histories, active infections, positive HIV/hepatitis tests, or a history of drug or alcohol misuse are generally not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The study will be conducted in 3 parts. Part1 MAD will consist of approximately 32 healthy subjects enrolled in up to 4 sequential Multiple Ascending Dose (MAD) dose cohorts and each cohort can comm

The study will be conducted in 3 parts. Part1 MAD will consist of approximately 32 healthy subjects enrolled in up to 4 sequential Multiple Ascending Dose (MAD) dose cohorts and each cohort can commence after the corresponding dose Single Ascending Dose (SAD) cohort has been completed and after Safety Review Committee approval. Each participant in all the 4 cohorts will receive oral doses of iN1011-N17 with matching placebo. Dosage Form: Capsules Mode of Administration: Oral Cohort 1: Healthy participants will receive oral dose of 100 mg iN1011-N17 twice daily (b.i.d) from Day 1 to Day 6, approximately 12 hours apart between the 2 daily doses and receive the morning last dose on Day 7 Cohort 2: Healthy participants will receive oral dose of 200 mg iN1011-N17 twice daily (b.i.d) from Day 1 to Day 6, approximately 12 hours apart between the 2 daily doses and receive the morning last dose on Day 7 Cohort 3: Healthy participants will receive oral dose of 400 mg iN1011-N17 twice daily (b.i.d) from Day 1 to Day 6, approximately 12 hours apart between the 2 daily doses and receive the morning last dose on Day 7 Cohort 4: Healthy participants will receive oral dose of 800 mg iN1011-N17 twice daily (b.i.d) from Day 1 to Day 6, approximately 12 hours apart between the 2 daily doses and receive the morning last dose on Day 7 Each cohort will enrol distinct group of participants Participants will be confined to the investigational site/institution and supervised for approximately 10 days (Day -1 to Day 9) and will be discharged from the investigational site/institution on Day 9, following satisfactory completion of all procedures and assessments. iN1011-N17 will be administered as an oral suspension (Cohort 1) and Nano Suspension powder capsule (Cohorts 2-5) Part 2: Approximately 16 participants will be enrolled into the study. It will be a open label study, cross over bioavailability study which will commence after completion of Part 1 with 2 cohorts. Here the participants in cohort 5 and 6 will receive both Regimen A (single dose of 400 mg iN1011-N17 hydrochloride salt capsule) and Regimen B (single dose of 400 mg iN1011-N17 mesylate salt capsule). Participants will receive a single oral dose of each study treatment (Regimens A and B), one during each of the 2 inpatient periods, in a randomized sequence of administration: AB (Cohort 5) or BA (Cohort 6). Part 3: MAD Study in Healthy Volunteers and Post-Herpetic Neuralgia Patients with iN1011-N17 Mesylate Salt (14 Days). This will enroll 8 healthy volunteers and 8 PHN patients who will be randomised in a ratio of 3:1 to receive iN1011-N17 or placebo. MAD Cohort 7 will commence after SRC review and assessment of the safety data from Part 2 of the study. Cohort 7- Healthy volunteers will receive oral dose of 400mg of iN1011-N17 mesylate salt capsule or placebo twice daily (b.i.d) from Day 1 to Day 13, approximately 12 hrs gap between 2 daily doses and receive last dose on Day 14 in the morning. Cohort 8- Post hepatic Neuralgia participants will an oral dose of 400mg of iN1011-N17 mesylate salt capsule or placebo twice daily (b.i.d) from Day 1 to Day 13, approximately 12 hrs gap between 2 daily doses and receive last dose on Day 14 in the morning.

Locations(1)

CMAX Clinical Research Pty Ltd - Adelaide

SA, Australia

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ACTRN12622001300763