RecruitingPhase 1NCT06218784

A MAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers and 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

64 participants

Start Date

Nov 11, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a 3-part, Double-blind, Randomized, Placebo-controlled, Multiple Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics/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 of iN1011-N17 in Healthy volunteers.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new oral pain medicine called iN1011-N17, which may help people with post-herpetic neuralgia — the persistent nerve pain that can linger after a shingles rash heals. Researchers want to understand how the drug moves through the body, whether it is safe, and whether it reduces pain. Healthy adults aged 18–55 and patients aged 50–75 with confirmed post-herpetic neuralgia lasting more than 3 months may be eligible to participate. Participation involves taking the study drug or a placebo by mouth over multiple days, with regular clinic visits for blood tests, vital sign checks, and pain assessments. This summary was generated by AI to help patients understand the study in plain language.

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

DRUGiN1011-N17 HCl Suspension (Part 1)

Dose: 100 mg b.i.d for 7 days (Multiple Ascending Dose)

DRUGiN1011-N17 HCl Capsule (Part 1)

Dose: 200, 400, 800 mg b.i.d for 7 days (Multiple Ascending Dose)

DRUGPlacebo Capsule (Part 1)

Dose: b.i.d for 7 days

DRUGiN1011-N17 HCl Capsule (Part 2)

Dose: 400 mg QD

DRUGiN1011-N17 Mesylate Capsule (Part 2)

Dose: 400 mg QD

DRUGiN1011-N17 HCl Capsule (Part 3)

Dose: 400 mg b.i.d for 14 days

DRUGiN1011-N17 Mesylate Capsule (Part 3)

Dose: 400 mg b.i.d for 14 days

DRUGPlacebo Capsule (Part 3)

Dose: b.i.d for 14 days


Locations(1)

CMAX Clinical Research

Adelaide, South Australia, Australia

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NCT06218784


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