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

NCT06218784 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2024-06-24

No results posted yet for this study

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

DRUG

iN1011-N17 HCl Suspension (Part 1)

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

DRUG

iN1011-N17 HCl Capsule (Part 1)

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

DRUG

Placebo Capsule (Part 1)

Dose: b.i.d for 7 days

DRUG

iN1011-N17 HCl Capsule (Part 2)

Dose: 400 mg QD

DRUG

iN1011-N17 Mesylate Capsule (Part 2)

Dose: 400 mg QD

DRUG

iN1011-N17 HCl Capsule (Part 3)

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

DRUG

iN1011-N17 Mesylate Capsule (Part 3)

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

DRUG

Placebo Capsule (Part 3)

Dose: b.i.d for 14 days

Sponsors & Collaborators

  • iN Therapeutics Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06218784 on ClinicalTrials.gov