A Phase I Study to Evaluate LSALT Peptide (NCT03772678) | Clinical Trial Compass
CompletedEarly Phase 1
A Phase I Study to Evaluate LSALT Peptide
Australia52 participantsStarted 2019-06-27
Plain-language summary
A phase I double-blind, placebo-controlled, randomized, single and multiple ascending dose finding study to evaluate the safety and pharmacokinetic profile of LSALT peptide in healthy participants
Who can participate
Age range18 Years ā 55 Years
SexALL
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Inclusion Criteria:
* No prior history of major organ or systemic disease including diabetes, hypertension, kidney, heart or liver disease. Participants with childhood asthma are acceptable.
* Normal hematology, clinical chemistry and urinalysis parameters at screening, unless not deemed clinically significant by the investigator.
* Body Mass Index (BMI) between 18 kg/m2 and 32 kg/m2 (inclusive)
* Taking no prescription medications 2 weeks prior to admission or over-the-counter medications 7 days prior to admission. Occasional use of paracetamol or ibuprofen (up to 1000 mg and 400 mg/day respectively) are acceptable. Routine vitamins and supplements are permissible at the discretion of the investigator.
* Able to allow intravenous medication to be administered.
* Males (along with their female partners) and females of childbearing potential (defined as a female who is not menopausal or surgically sterilized) must be willing to use an acceptable method of birth control during heterosexual activities including a condom and a second highly effective method (i.e., hormonal contraceptive, intra-uterine device) or abstinence for the duration of the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Males should continue with the aforementioned contraception for 90 days after the last dose and females should continue with the aforementioned contraception for 60 days after last dose.ā¦