Clinical trial NCT04748536: Safety and PK of Repeated Doses of IRL201104 in Healthy Volunteers
Official title: A Randomised, Double-blind, Placebo-controlled, Parallel Group Study in Healthy Volunteers to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Ascending Doses of IRL201104 to Support a Future COVID-19 Patient Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Revolo Biotherapeutics
Sponsor class: INDUSTRY
First posted: 2021-02-10
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Number of subjects with TEAEs and number of events will be summarised by treatment
timeFrame: 33 (group 1) or 35 (group 2) days
measure: Number of subjects with potentially clinically important (PCI) abnormal haematology variables will be summarised by treatment
timeFrame: 19 (group 1) or 21 (group 2) days
measure: Number of subjects with PCI abnormal clinical chemistry variables will be summarised by treatment
timeFrame: 19 (group 1) or 21 (group 2) days
measure: Number of subjects with PCI and/or abnormal electrocardiogram variables will be summarised by treatment
timeFrame: 19 (group 1) or 21 (group 2) days
measure: Number of subjects with PCI abnormal vital sign variables will be summarised by treatment
timeFrame: 19 (group 1) or 21 (group 2) days
Secondary outcomes:
measure: Pharmacokinetics of IRL201104: Trough blood concentration (Ctrough)
timeFrame: 5 (group 1) or 7 (group 2) days
measure: PK of IRL201104: Maximum (peak) blood concentration (Cmax)
timeFrame: 5 (group 1) or 7 (group 2) days
measure: PK of IRL201104: Terminal half life (t1/2)
timeFrame: 5 (group 1) or 7 (group 2) days
measure: PK of IRL201104: Area under the curve from time zero to last quantifiable concentration of IRL201104 (AUCt)
timeFrame: 5 (group 1) or 7 (group 2) days
measure: PK of IRL201104: Apparent total body clearance from blood (CLss)
timeFrame: 5 (group 1) or 7 (group 2) days
measure: PK of IRL201104: steady state volume of distribution (Vz)
timeFrame: 5 (group 1) or 7 (group 2) days
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Hammersmith Medicines Research
Study officials:
References: