A Study to Evaluate the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Properties of iN1011-N17 after Oral Administration in Healthy Volunteers and Post-Herpetic Neuralgia (PHN) Patients

Exclusion Criteria30

• 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).
• 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.
• 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 pharmacokinetic characteristics of the IP.
• Presence or history of central nervous system disease that may affect assessment of safety and PK characteristics of the IP.
• 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.
• History of hypersensitivity to iN1011-N17 or to any of its components.
• History of allergy or sensitivity to sulfonamides.
• Any abnormal 12-lead electrocardiogram (ECG) findings at Screening and Day -1, deemed by the Investigator or designee to be clinically significant.
• Positive test for hepatitis B surface antigen (HBsAg), hepatitis C (HCV), or human immunodeficiency virus (HIV) at Screening.
• Positive urine drug screen test (including amphetamines, methamphetamines, methadone, barbiturates, benzodiazepines, cocaine, opiates, methylenedioxymethamphetamine, phencyclidine, and tetrahydrocannabinol) or alcohol breath test at Screening and Day -1. Repeated tests will be allowed at the discretion of the Investigator for suspected false positives.
• Any of the following laboratory abnormalities within 14 days of the first treatment day:
• Platelet count less than 100,000 cells/mm3
• Total neutrophil count less than 1500 cells/mm3
• Serum creatinine greater than 1.5 x ULN
• Alanine aminotransferase (ALT) greater than 3.0 x ULN
• Aspartate aminotransferase (AST) greater than 3.0 x ULN
• Alkaline phosphatase greater than 2.0 x ULN
• Bilirubin greater than 1.5 x ULN
• Temperature greater than 38°C or any other evidence of an infection
• History of fracture in the lower limb or joint under investigation which may impede pain assessment / pain scores or may prevent accurate sensory testing.
• Use of any prescription drugs within 14 days, and for over the counter (OTC) medications, herbal remedies (including St John’s Wort), dietary supplements or vitamins within 7 days, or five half-lives of the product, whichever is longer, before the first dose of IP and for the duration of the study without prior approval of the Investigator and the MM. This includes analgesics such as paracetamol and non-steroidal anti-inflammatories (for HVs only).
• The use of any IP or investigational medical device within 30 days prior to Screening, or five half-lives of the product, whichever is longer.
• Blood or plasma donation of more than 450 mL within 90 days before the first dose of IP and for the duration of the study. It is recommended that blood/plasma donations not be made for at least 30 days after study completion.
• History of alcoholism, substance or drug abuse-related disorders deemed significant by the Investigator (or designee) (i.e., more than 21 units per week for males and more than 14 units per week for females. One unit of alcohol equals ½ pint [285 mL] of beer or lager, 1 glass [125 mL] of wine, or 1/6 gill [25 mL] of spirits).
• Use of more than 5 nicotine-based products (including smoking tobacco, smokeless tobacco, and nicotine patches) per week, within 90 days prior to Screening. Volunteers must have a negative urine cotinine test at both Screening and Day -1 and refrain from the use of any nicotine-based products for the duration of the study.
• Consumption of beverages or foods that contain grapefruit, star fruit, pomelos, or products containing these fruits, from 7 days, or from the time that is deemed significant by the Investigator, and products containing caffeine (e.g., coffee, green tea, black tea, and sodas) from 48 hours before the first dose of IP until discharge from the study unit.
• Unwilling to refrain from strenuous exercise from 48 hours prior to admission to the investigational site/institution and for the duration of the study, where strenuous exercise is defined as that which requires significant effort, energy, or strength, such as lifting weights or running.
• Any other reason that, in the opinion of the Investigator, may affect assessment of safety, PK, or PD characteristics of the IP.
• Have previously completed or withdrawn from this study or any other study investigating iN1011-N17 or have previously received the IP (only for HVs).
• Received an investigational vaccine within 6 months, a live attenuated vaccine within 60 days, or a registered vaccine within 14 days prior to the Day -1 (Baseline visit).