Safety and PK of Repeated Doses of IRL201104 in Healthy Volunteers
- Registration Number
- NCT04748536
- Lead Sponsor
- Revolo Biotherapeutics
- Brief Summary
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of repeat doses of IRL201104 given to healthy volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1: Dose A IRL201104 or placebo Placebo IRL201104 IV once daily for 5 days OR Placebo IV once daily for 5 days Group 2: Dose B IRL201104 or placebo Placebo IRL201104 IV once daily for 7 days OR Placebo IV once daily for 7 days Group 1: Dose A IRL201104 or placebo IRL201104 IRL201104 IV once daily for 5 days OR Placebo IV once daily for 5 days Group 2: Dose B IRL201104 or placebo IRL201104 IRL201104 IV once daily for 7 days OR Placebo IV once daily for 7 days
- Primary Outcome Measures
Name Time Method Number of subjects with PCI and/or abnormal electrocardiogram variables will be summarised by treatment 19 (group 1) or 21 (group 2) days RR, PR, QRS, QT-interval, QTcF and heart rate will be collected at baseline and after dose administration and repeated until Day 19 or 21.
Number of subjects with PCI abnormal vital sign variables will be summarised by treatment 19 (group 1) or 21 (group 2) days Blood pressure, pulse rate, oral body temperature and respiration rate will be collected at baseline and after single and multiple dose administration and repeated until Day 19 or 21
Number of subjects with potentially clinically important (PCI) abnormal haematology variables will be summarised by treatment 19 (group 1) or 21 (group 2) days Haemoglobin, haematocrit, MCV, MCH, MCHC, RBC, WBC and differentials will be collected at baseline and after dose administration and repeated until Day 19 or 21
Number of subjects with PCI abnormal clinical chemistry variables will be summarised by treatment 19 (group 1) or 21 (group 2) days Creatinine, glucose, triglycerides, urea, uric acid, bilirubin, cholesterol, sodium, potassium, alkaline phosphatase, AST, ALT and GGT will be collected at baseline and after dose administration and repeated until Day 19 or 21
Number of subjects with TEAEs and number of events will be summarised by treatment 33 (group 1) or 35 (group 2) days Adverse Events after treatment administration will be collected at baseline and repeated until study completion
- Secondary Outcome Measures
Name Time Method PK of IRL201104: Apparent total body clearance from blood (CLss) 5 (group 1) or 7 (group 2) days CLss will be calculated after multiple dosing
Pharmacokinetics of IRL201104: Trough blood concentration (Ctrough) 5 (group 1) or 7 (group 2) days Ctrough will be measured after multiple dosing
PK of IRL201104: Maximum (peak) blood concentration (Cmax) 5 (group 1) or 7 (group 2) days Cmax will be calculated after multiple dosing
PK of IRL201104: Area under the curve from time zero to last quantifiable concentration of IRL201104 (AUCt) 5 (group 1) or 7 (group 2) days AUCt will be calculated after multiple dosing
PK of IRL201104: Terminal half life (t1/2) 5 (group 1) or 7 (group 2) days t1/2 will be calculated after multiple dosing
PK of IRL201104: steady state volume of distribution (Vz) 5 (group 1) or 7 (group 2) days Vz will be calculated after multiple dosing
Trial Locations
- Locations (1)
Hammersmith Medicines Research
🇬🇧London, United Kingdom