Multiple Ascending Oral Dose 14-Day Trial of LHF-535 in Healthy Participants (NCT03993704) | Clinical Trial Compass
CompletedPhase 1
Multiple Ascending Oral Dose 14-Day Trial of LHF-535 in Healthy Participants
Australia24 participantsStarted 2019-09-16
Plain-language summary
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of a daily oral dose of LHF-535 administered for 14 days to healthy participants.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion Criteria:
* Male or female 18 to 50 years of age, inclusive, at the time of screening
* Able to understand the requirements of the study, to provide written informed consent (as evidenced by signature on an informed consent document that is approved by a Human Research Ethics Committee \[HREC\]), and agreeable to abide by the study restrictions
* Body mass index (BMI) of 18.0 to 35.0 kg/m\^2, inclusive, at the time of screening
* Weight between 50 kg and 110 kg, inclusive, at the time of screening and check-in (Day -1)
* Good general health (e.g., no chronic health conditions such as hypertension, diabetes, chronic obstructive pulmonary disease, or cardiovascular disease) as determined by the Investigator; participants with mild allergies or benign conditions such as Gilbert's disease may be enrolled at the discretion of the Investigator
* Female participants of child-bearing potential, with a fertile male sexual partner, must use a highly effective method of contraception (oral contraceptive, intrauterine device, or hormonal patch, injectable, or implantable device) in conjunction with a male condom during the screening period and for the entire duration of study participation including the 28-day follow-up; true abstinence from sexual intercourse with a partner of the opposite sex, in accordance with the preferred and usual lifestyle of the participant, is acceptable; periodic abstinence or avoiding sexual intercourse on days while the participant is fertile (cal…
What they're measuring
1
Number of Participants with Treatment Emergent Adverse Events as Assessed by CTCAE v4.0