TRUE-1: Trial of Repurposed Unithiol for snakebite Envenoming Phase 1 (Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Kenyan Adults)

iverpool School of Tropical Medicine0 个研究点目标入组 64 人开始时间: 2021年3月2日最近更新: 2023年5月29日

试验速览

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•Capable of giving informed consent
•Male or female
•KHDSS resident
•18-64 years old (inclusive)
•Body weight 50-120kg
•In good health, as determined by the investigator following medical history, drug history, examination, vital signs, ECG and blood tests
•Willing to be admitted to the in-patient facility for up to 5 days for dosing and intensive blood sampling
•On effective contraception as defined by: Use of effective method of contraception for duration of study (women only). We will ask the female volunteers to come with their family planning records to verify. Effective contraception is defined as a contraceptive method with failure rate of less than 1% per year when used consistently and correctly, in accordance with the product label. Examples of these include: combined oral contraceptives; injectable progestogen; implants of etenogestrel or levonorgestrel; intrauterine device or intrauterine system; male partner sterilisation at least 6 months prior to the female subject’s entry into the study, and the relationship is monogamous; male condom combined with a vaginal spermicide (foam, gel, film, cream or suppository); and male condom combined with a female diaphragm, either with or without a vaginal spermicide (foam, gel, film, cream, or suppository).

•Prescribed a concomitant medication other than paracetamol or an appropriate contraceptive, which in the opinion of the Investigator warrants exclusion.
•Any significant current or past history of cardiovascular, respiratory, renal or hepatic disease.
•Subjects who have taken any non-prescribed herbal medication or mineral supplement in the preceding 7 days, which in the opinion of the Investigator warrants exclusion.
•Subject with clinically significant abnormal vital signs at screening
•Abnormal laboratory findings deemed significant by the Investigator
•Subjects who are pregnant or lactating
•Decline pre-trial screening, including HIV testing
•HIV positive subjects will be excluded from the trial and, if not already receiving appropriate clinic follow-up, would be referred to a government clinic for ongoing care
•Subjects with asthma (due to possible risk of exacerbation with allergic type skin reactions to unithiol)
•Subjects that have donated blood within the past 3 months
•Subjects who in the opinion of the investigator should not participate

发起方

iverpool School of Tropical Medicine