NCT06218784View on ClinicalTrials.gov

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

PHASE1RecruitingINTERVENTIONAL
Enrollment

64

Participants

Timeline

Start Date

November 11, 2022

Primary Completion Date

July 29, 2024

Study Completion Date

July 29, 2024

Conditions
Post Herpetic NeuralgiaPainOsteoarthritisNeuropathic PainChronic PainDorsal Root GanglionNav 1.7
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

Trial Locations (1)

5000

RECRUITING

CMAX Clinical Research, Adelaide

All Listed Sponsors
lead

iN Therapeutics Co., Ltd.

INDUSTRY