A Phase I, prospective, double-blind, randomised, placebo-controlled, dose escalation study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending oral doses of KCL-286 and the effects of food in healthy male participants

King's College London0 个研究点目标入组 109 人开始时间: 2018年7月18日最近更新: 2023年8月2日

适应症

试验速览

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37452623/ (added 18/07/2023)

•1. Healthy males
•2. Aged 19 to 45 years at screening
•3. Able to understand and willing to follow the requirements for the study and provide written informed consent
•4. Willing to avoid direct sunlight, use sun cream and cover arms and legs and to wear sunglasses and sunhat when outside during treatment and until final visit
•5. Non-smokers from at least 3 months before receiving the first dose of study drug and for the duration of the study
•6. Participants who are sexually active must agree to use barrier contraception with a spermicide from the time of the first dose until 3 months after the last dose (participants whose female partners are trying to become pregnant will be excluded)
•7. Body mass index (BMI) =18 and =30 kg/m2
•8. Body weight =55 kg at screening

•1. Current or recent (within 3 months of screening) use of sunbeds
•2. Current or recent (less than 5 years) history of drug or alcohol abuse or a positive drugs of abuse test
•3. Current or past history of psychiatric conditions or suicidal ideation
•4. History or presence of any clinically relevant allergy
•5. Consumption of prescription or over-the-counter medications (including vitamins, herbal and mineral supplements) within 14 days prior to study drug administration until (with the exception of occasional paracetamol) the end of the study

发起方