ACTRN12622001300763招募中1 期
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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •Healthy Volunteers:
- •1. Healthy male and female adults, aged 18 to 55 years of age at the time of consent.
- •2. Body mass index (BMI equal to 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.
- •3. Clinically acceptable blood pressure (BP), pulse, RR, and body temperature (systolic blood pressure [SBP] between 90 and 140 mmHg; diastolic blood pressure [DBP] between 50 and 90 mmHg; pulse between 45 and100 bpm; RR between 12 and 22 breaths/min; 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.
- •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. For 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 investigational product (IP). Female participants must not be breastfeeding, lactating, or 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.
排除标准
- •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 pharmacokinetic 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.
- •8. Any abnormal 12-lead electrocardiogram (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.
- •10. 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.
- •11. 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
- •12. History of fracture in the lower limb or joint under investigation which may impede pain assessment / pain scores or may prevent accurate sensory testing.
- •13. 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).
- •14. 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.
- •15. 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.
研究者
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