Safety and PK of Repeated Doses of IRL201104 in Healthy Volunteers

Healthy Volunteer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04748536
• Other study ID #: C1104-003
• Status: Completed
• Phase: Phase 1
• Start date: January 29, 2021
• Est. completion date: April 5, 2021

Study information

• Verified date: February 2021
• Source: Revolo Biotherapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of repeat doses of IRL201104 given to healthy volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 5, 2021
• Est. primary completion date: April 5, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• IRL201104
lyophilised powder for reconstitution for IV dosing
• Placebo
Matching placebo for IRL201104

Locations

Country	Name	City	State
United Kingdom	Hammersmith Medicines Research	London

Sponsors (1)

Lead Sponsor	Collaborator
Revolo Biotherapeutics

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with TEAEs and number of events will be summarised by treatment	Adverse Events after treatment administration will be collected at baseline and repeated until study completion	33 (group 1) or 35 (group 2) days
Primary	Number of subjects with potentially clinically important (PCI) abnormal haematology variables will be summarised by treatment	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	19 (group 1) or 21 (group 2) days
Primary	Number of subjects with PCI abnormal clinical chemistry variables will be summarised by treatment	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	19 (group 1) or 21 (group 2) days
Primary	Number of subjects with PCI and/or abnormal electrocardiogram variables will be summarised by treatment	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.	19 (group 1) or 21 (group 2) days
Primary	Number of subjects with PCI abnormal vital sign variables will be summarised by treatment	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	19 (group 1) or 21 (group 2) days
Secondary	Pharmacokinetics of IRL201104: Trough blood concentration (Ctrough)	Ctrough will be measured after multiple dosing	5 (group 1) or 7 (group 2) days
Secondary	PK of IRL201104: Maximum (peak) blood concentration (Cmax)	Cmax will be calculated after multiple dosing	5 (group 1) or 7 (group 2) days
Secondary	PK of IRL201104: Terminal half life (t1/2)	t1/2 will be calculated after multiple dosing	5 (group 1) or 7 (group 2) days
Secondary	PK of IRL201104: Area under the curve from time zero to last quantifiable concentration of IRL201104 (AUCt)	AUCt will be calculated after multiple dosing	5 (group 1) or 7 (group 2) days
Secondary	PK of IRL201104: Apparent total body clearance from blood (CLss)	CLss will be calculated after multiple dosing	5 (group 1) or 7 (group 2) days
Secondary	PK of IRL201104: steady state volume of distribution (Vz)	Vz will be calculated after multiple dosing	5 (group 1) or 7 (group 2) days