Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06218784

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

Status
Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
64 (estimated)
Sponsor
iN Therapeutics Co., Ltd. · Industry
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
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

Timeline

Start date
2022-11-11
Primary completion
2024-07-29
Completion
2024-07-29
First posted
2024-01-23
Last updated
2024-06-24

Locations

1 site across 1 country: Australia

Source: ClinicalTrials.gov record NCT06218784. Inclusion in this directory is not an endorsement.