drugset / Trial / NCT06218784

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

NCT06218784 ↗

Phase 1 Unknown 64 enrolled iN Therapeutics Co., Ltd.
RandomizedSequentialQuadruple-blindTreatment

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.

Timeline

Start
2022-11-11
Primary completion
2024-07-29
Completion
2024-07-29

Drugs

EvaluationDrugModalityDoseRoute
Subject iN1011-N17 Unknown 100 mg Oral
Subject iN1011-N17 Unknown 200 mg Oral
Subject iN1011-N17 Unknown 400 mg Oral
Subject iN1011-N17 Unknown 800 mg Oral