Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics/pharmacodynamics properties of iN1011N17

Phase 1

Recruiting

• Conditions: osteoarthritis pain; Musculoskeletal - Osteoarthritis; Anaesthesiology - Pain management

• Registration Number: ACTRN12620001253998
• Lead Sponsor: iN Therapeutics Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-23
• Last Update Posted: 21 February 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1.Healthy male and female adults, aged 18 to 55 years (inclusive at the time of written informed consent).
2.Body mass index (BMI equals 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 50 kg.
3.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.
4.Clinically acceptable blood pressure (BP), pulse, respiratory rate (RR), and body temperature (systolic blood pressure [SBP] between 90 and 140 mmHg; diastolic blood pressure [DBP] between 40 and 90 mmHg; pulse between 40 and100 bpm; RR between 10 and 22 breaths/min; body temperature between 35.5°C and 37.5°C) at Screening and Day -1. Measurements are to be recorded after a minimum of 5 minutes of resting in sitting or supine position.
5.Subjects (excluding who are exclusively in same-sex relationships) 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 investigational product (IP). Female subjects must not be breastfeeding, lactating or planning pregnancy during the study period.
6.Cognitively capable of understanding the provided information and able to fully comply with protocol requirements.
7.Written informed consent prior to the commencement of any study procedures.
8.Willing and able to perform the necessary visits to the investigational site/institution.
9.In good general health at the Investigator’s discretion, with no significant medical history, and with no clinically significant abnormalities on physical examination at Screening and before the first dose of IP.

Exclusion Criteria

1. Presence or history of hepatic, renal, neurological, pulmonary, endocrine, hematologic, cardiovascular or genitourinary disease.
2. Presence of any underlying physical or psychiatric condition that, in the opinion of the Investigator, would undermine subject 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 pharmacokinetic characteristics of the IP.
4. History of hypersensitivity to iN1011N17 or to any of its components.
5. Any abnormal 12-lead electrocardiogram (ECG) findings at Screening and Day -1, deemed by the Investigator or designee to be clinically significant.
6. Positive test for hepatitis B surface antigen (HBsAg), hepatitis C (HCV), or human immunodeficiency virus (HIV) at Screening.
7. 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.
8. Any history (i.e., within 5 years) of substance abuse or treatment (including alcohol) or is unwilling to agree to abstain from alcohol and drugs from 48 hours prior to Screening and for the duration of the study.
9. History of fracture or other significant injury to dominant arm or current injury or condition, such as carpel tunnel syndrome, that may prevent accurate sensory testing.
10. 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 Medical Monitor (MM). This includes analgesics such as paracetamol and non-steroidal anti-inflammatories.
11. 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.
12. 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.
13. An average weekly alcohol intake that exceeds 21 units per week for males and 14 units per week for females (1 unit equal to 10 g of pure alcohol).
14. Use of more than five nicotine-based products (including smoking tobacco, smokeless tobacco, and nicotine patches) per week, within 90 days prior to Screening. Subjects 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.
15. Consumption of beverages or foods that contain alcohol, grapefruit, star fruit, pomelos, or products containing these fruits, from 7 days, and products containing caffeine (e.g., coffee, green tea, black tea and sodas) from 72 hours before the first dose of IP until study completion.
16. 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, suc

Study & Design

• Study Type: Interventional
• Study Design: Not specified