Status:
COMPLETED
Safety and PK of Repeated Doses of IRL201104 in Healthy Volunteers
Lead Sponsor:
Revolo Biotherapeutics
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of repeat doses of IRL201104 given to healthy volunteers.
Eligibility Criteria
Inclusion
- Healthy male and female subjects age 18 to 65 years of age, and in good health as determined by medical history, physical examination, vital signs, electrocardiogram, and laboratory tests.
- Female subjects agree to use highly effective contraception or be of non-childbearing potential.
- Written informed consent must be obtained before any assessment is performed.
- Able to communicate well with the Investigator/designee.
Exclusion
- Any known reaction to study drug or components
- concurrent or recent infection or clinically significant conditions that may place subject at risk or interference with absorption, distribution or excretion of drugs
- No QTcF interval ≥450 milliseconds, no QRS complex ≥120 milliseconds, at Screening
- Positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (HCVAb) or human immunodeficiency virus (HIV) 1 and/or -2 antibodies at Screening.
- Excessive use of caffeine-containing beverages
- Urinary cotinine level indicative of smoking or history or regular use of tobacco- or nicotine containing products within 6 months before screening.
- Presence or history of drug of alcohol abuse.
- Positive screen for drugs-of-abuse or cotinine.
- Blood donation in excess of 500mL within 3 months.
- Participation in another clinical study with licensed or unlicensed study drug within 3 months of first IMP administration.
- Exposure to more than 4 new chemical entities within 12 months before the first IMP administration.
- Use of live vaccine 28 days before dosing with study drug until telephone follow-up and use of killed vaccine (including COVID-19 vaccine) 14 days before dosing with study drug until telephone follow-up.
Key Trial Info
Start Date :
January 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 5 2021
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04748536
Start Date
January 29 2021
End Date
April 5 2021
Last Update
April 26 2021
Active Locations (1)
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1
Hammersmith Medicines Research
London, United Kingdom