RecruitingPhase 1

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

Australia64 participantsStarted 2022-11-11

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Healthy male and female adults, aged 18 to 55 years of age (inclusive) at the time of consent.
. Body mass index (BMI = body weight (kg)/\[height (m)\]2) between 18 kg/m2 and 32 kg/m2 (inclusive) at the time of Screening, and a minimum weight of 45 kg (inclusive).
. Clinically acceptable pulse rate, RR, and tympanic body temperature (pulse rate between 45 and 100 beats per minute \[bpm\]; SBP between 90 and 140 mmHg; DBP between 50 and 90 mmHg; RR between 12 and 22 breaths/min; tympanic body temperature between 35.5°C and 37.7°C at Screening and Day -1). Measurements are to be recorded after a minimum of 5 minutes of resting in sitting or supine position
. Clinical laboratory values within normal range as specified by the testing laboratory at Screening and Day -1, unless deemed not clinically significant by the Investigator.
. All participants (excluding those who are exclusively in same-sex relationships, who are postmenopausal or have an exclusive partner who is postmenopausal) must agree to use a highly effective method of contraception throughout the study and for at least 30 days for females or 90 days for males after the last dose of IP. Female participants must not be breastfeeding, lactating, or pregnant during the study period.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence, severity, and causality of AEs and serious AEs (SAEs)

Timeframe: Part 1: From baseline until follow-up, an average of 14 days Part 2: From baseline until follow-up, an average of 22 days Part 3: From baseline until follow-up, up to 21 days

Incidence of Physical examination abnormalities

Timeframe: Part 1: From baseline until follow-up, an average of 14 days Part 2: From baseline until follow-up, an average of 22 days Part 3: From baseline until follow-up, up to 21 days

Incidence of Vital signs abnormalities

Timeframe: Part 1: From baseline until follow-up, an average of 14 days Part 2: From baseline until follow-up, an average of 22 days Part 3: From baseline until follow-up, up to 21 days

Incidence of 12-lead ECG abnormalities

Timeframe: Part 1: From baseline until follow-up, an average of 14 days Part 2: From baseline until follow-up, an average of 22 days Part 3: From baseline until follow-up, up to 21 days

Incidence of Continous cardiac telemetry abnormalities

Timeframe: Part 1: From baseline until follow-up, an average of 14 days Part 2: From baseline until follow-up, an average of 22 days Part 3: From baseline until follow-up, up to 21 days

Trial details

NCT IDNCT06218784

SponsoriN Therapeutics Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-07-29

Contact for this trial

Yeseul Shin

+82313328425 hangsu1208@intherapeutics.com

View on ClinicalTrials.gov More Post Herpetic Neuralgia trials

Plain-language summary

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Healthy male and female adults, aged 18 to 55 years of age (inclusive) at the time of consent.
. Body mass index (BMI = body weight (kg)/\[height (m)\]2) between 18 kg/m2 and 32 kg/m2 (inclusive) at the time of Screening, and a minimum weight of 45 kg (inclusive).
. Clinically acceptable pulse rate, RR, and tympanic body temperature (pulse rate between 45 and 100 beats per minute \[bpm\]; SBP between 90 and 140 mmHg; DBP between 50 and 90 mmHg; RR between 12 and 22 breaths/min; tympanic body temperature between 35.5°C and 37.7°C at Screening and Day -1). Measurements are to be recorded after a minimum of 5 minutes of resting in sitting or supine position
. Clinical laboratory values within normal range as specified by the testing laboratory at Screening and Day -1, unless deemed not clinically significant by the Investigator.
. All participants (excluding those who are exclusively in same-sex relationships, who are postmenopausal or have an exclusive partner who is postmenopausal) must agree to use a highly effective method of contraception throughout the study and for at least 30 days for females or 90 days for males after the last dose of IP. Female participants must not be breastfeeding, lactating, or pregnant during the study period.

What they're measuring

Incidence, severity, and causality of AEs and serious AEs (SAEs)

Timeframe: Part 1: From baseline until follow-up, an average of 14 days Part 2: From baseline until follow-up, an average of 22 days Part 3: From baseline until follow-up, up to 21 days

Incidence of Physical examination abnormalities

Timeframe: Part 1: From baseline until follow-up, an average of 14 days Part 2: From baseline until follow-up, an average of 22 days Part 3: From baseline until follow-up, up to 21 days

Incidence of Vital signs abnormalities

Timeframe: Part 1: From baseline until follow-up, an average of 14 days Part 2: From baseline until follow-up, an average of 22 days Part 3: From baseline until follow-up, up to 21 days

Incidence of 12-lead ECG abnormalities

Timeframe: Part 1: From baseline until follow-up, an average of 14 days Part 2: From baseline until follow-up, an average of 22 days Part 3: From baseline until follow-up, up to 21 days

Incidence of Continous cardiac telemetry abnormalities

Timeframe: Part 1: From baseline until follow-up, an average of 14 days Part 2: From baseline until follow-up, an average of 22 days Part 3: From baseline until follow-up, up to 21 days

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

Exclusion criteria