Loading clinical trials...

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

RECRUITINGPHASE1

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

NCT06218784•iN Therapeutics Co., Ltd.

View on ClinicalTrials.gov

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

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy Volunteers
•1. Healthy male and female adults, aged 18 to 55 years of age (inclusive) at the time of consent.
•2. 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).
•3. 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
•For Healthy Volunteers and Post-Herpetic Neuralgia Patients
•4. 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.
•5. 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.
•Female participants are required to be on their chosen contraceptive for at least 7 days before dosing.
•Female participants, where their sole, male sexual partner is vasectomized, must provide a verbal confirmation of azoospermia (90 days following the procedure) which should be recorded in the source documents by the Investigator.
•The minimum timeframe for pre-dose vasectomy for male participants is ≥ 12 weeks, unless they are the sole sexual partner of a female participant as outlined above.
+11 more criteria

Exclusion Criteria

•For Healthy Volunteers and Post-Herpetic Neuralgia Patients
•1. Presence or history of carcinoma, hepatic, renal, neurological, pulmonary (except for childhood asthma), endocrine, hematologic, cardiovascular, or genitourinary disease that, in the opinion of the Investigator, may affect the evaluation of the IP or place the participant at undue risk (except for conditions that are stable on medications).
•2. Presence of any underlying physical or psychiatric condition (except for conditions that are stable on medications) that, in the opinion of the Investigator, would undermine participant compliance to protocol requirements.
•3. Presence or history of gastrointestinal disease (e.g., peptic ulcer, gastritis, gastric cramp, gastroesophageal reflex disease, Crohn's disease) or history of gastrointestinal surgery (except simple appendectomy or herniorrhaphy) that may affect assessment of safety and PK characteristics of the IP.
•4. Presence or history of central nervous system disease that may affect assessment of safety and PK characteristics of the IP.
•5. Presence of herniated disc (inter-vertebral, cervical or both) or history of related disease that, in the opinion of the Investigator, may affect assessment of safety and PK characteristics of the IP.
•6. History of hypersensitivity to iN1011-N17 or to any of its components.
•7. History of allergy or sensitivity to sulfonamides, hay fever, asthma, eczema, food allergies and/or allergies to other medications. Participants with asymptomatic, untreated, seasonal allergies at the time of dosing may be considered for inclusion on a case-by-case basis- PI and Sponsor approval must be obtained prior to randomization.
•8. Any abnormal 12-lead ECG findings at Screening and Day -1, deemed by the Investigator or designee to be clinically significant.
•9. Positive test for hepatitis B surface antigen (HBsAg), hepatitis C (HCV), or human immunodeficiency virus (HIV) at Screening.
+26 more criteria

Locations (1)

CMAX Clinical Research

Adelaide, South Australia, Australia

Key Dates

Start Date

November 11, 2022

Primary Completion Date

July 29, 2024

Completion Date

July 29, 2024

Last Updated

June 24, 2024

Enrollment

ESTIMATED participants

Conditions

Post Herpetic NeuralgiaPainOsteoarthritisNeuropathic PainChronic PainDorsal Root GanglionNav 1.7

Interventions

iN1011-N17 HCl Suspension (Part 1)

DRUG

iN1011-N17 HCl Capsule (Part 1)

DRUG

Placebo Capsule (Part 1)

DRUG

iN1011-N17 HCl Capsule (Part 2)

DRUG

iN1011-N17 Mesylate Capsule (Part 2)

DRUG

iN1011-N17 HCl Capsule (Part 3)

DRUG

iN1011-N17 Mesylate Capsule (Part 3)

DRUG

Placebo Capsule (Part 3)

DRUG

Contacts

Yeseul Shin

CONTACT

+82313328425 hangsu1208@intherapeutics.com

Effect of Virtual Reality on Patient's Comfort During Cardiac Electronic Device Implantation.

NCT06346132

Virtual RealityMedical Device+2 more

View study

RECRUITINGPHASE3

A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and Osteoarthritis (OA) of the Knee

NCT07153471

Osteoarthritis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 24, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Effect of Virtual Reality on Patient's Comfort During Cardiac Electronic Device Implantation.

A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and Osteoarthritis (OA) of the Knee

A Phase Ib Study to Evaluate the Efficacy and Safety of HRS-2129 in Patients With Knee Osteoarthritis

Comparison Between Tranversus Abdominis Plane (TAP) Block With Only Bupivacaine and TAP Block With Bupivacaine Plus Ketamine in Reducing Postoperative Pain After Total Abdominal Hystrectomy

Intertransverse Process Block to Improve Quality of Recovery and Pain Management in Adult Cardiac Surgical Patients

CBD for Pain Following Orthopedic Shoulder Surgery