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Safety and PK of Repeated Doses of IRL201104 in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT04748536
Recruitment Status : Completed
First Posted : February 10, 2021
Last Update Posted : April 26, 2021
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: IRL201104 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : January 29, 2021
Actual Primary Completion Date : April 5, 2021
Actual Study Completion Date : April 5, 2021

Arm Intervention/treatment
Experimental: Group 1: Dose A IRL201104 or placebo
IRL201104 IV once daily for 5 days OR Placebo IV once daily for 5 days
Drug: IRL201104
lyophilised powder for reconstitution for IV dosing

Drug: Placebo
Matching placebo for IRL201104

Experimental: Group 2: Dose B IRL201104 or placebo
IRL201104 IV once daily for 7 days OR Placebo IV once daily for 7 days
Drug: IRL201104
lyophilised powder for reconstitution for IV dosing

Drug: Placebo
Matching placebo for IRL201104




Primary Outcome Measures :
  1. Number of subjects with TEAEs and number of events will be summarised by treatment [ Time Frame: 33 (group 1) or 35 (group 2) days ]
    Adverse Events after treatment administration will be collected at baseline and repeated until study completion

  2. Number of subjects with potentially clinically important (PCI) abnormal haematology variables will be summarised by treatment [ Time Frame: 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

  3. Number of subjects with PCI abnormal clinical chemistry variables will be summarised by treatment [ Time Frame: 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

  4. Number of subjects with PCI and/or abnormal electrocardiogram variables will be summarised by treatment [ Time Frame: 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.

  5. Number of subjects with PCI abnormal vital sign variables will be summarised by treatment [ Time Frame: 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


Secondary Outcome Measures :
  1. Pharmacokinetics of IRL201104: Trough blood concentration (Ctrough) [ Time Frame: 5 (group 1) or 7 (group 2) days ]
    Ctrough will be measured after multiple dosing

  2. PK of IRL201104: Maximum (peak) blood concentration (Cmax) [ Time Frame: 5 (group 1) or 7 (group 2) days ]
    Cmax will be calculated after multiple dosing

  3. PK of IRL201104: Terminal half life (t1/2) [ Time Frame: 5 (group 1) or 7 (group 2) days ]
    t1/2 will be calculated after multiple dosing

  4. PK of IRL201104: Area under the curve from time zero to last quantifiable concentration of IRL201104 (AUCt) [ Time Frame: 5 (group 1) or 7 (group 2) days ]
    AUCt will be calculated after multiple dosing

  5. PK of IRL201104: Apparent total body clearance from blood (CLss) [ Time Frame: 5 (group 1) or 7 (group 2) days ]
    CLss will be calculated after multiple dosing

  6. PK of IRL201104: steady state volume of distribution (Vz) [ Time Frame: 5 (group 1) or 7 (group 2) days ]
    Vz will be calculated after multiple dosing



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04748536


Locations
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United Kingdom
Hammersmith Medicines Research
London, United Kingdom
Sponsors and Collaborators
Revolo Biotherapeutics
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Responsible Party: Revolo Biotherapeutics
ClinicalTrials.gov Identifier: NCT04748536    
Other Study ID Numbers: C1104-003
First Posted: February 10, 2021    Key Record Dates
Last Update Posted: April 26, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No