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
iN Therapeutics Co., Ltd.
64 participants
Nov 11, 2022
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
Plain Language Summary
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Interventions
Dose: 100 mg b.i.d for 7 days (Multiple Ascending Dose)
Dose: 200, 400, 800 mg b.i.d for 7 days (Multiple Ascending Dose)
Dose: b.i.d for 7 days
Dose: 400 mg QD
Dose: 400 mg QD
Dose: 400 mg b.i.d for 14 days
Dose: 400 mg b.i.d for 14 days
Dose: b.i.d for 14 days
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06218784