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Safety and PK of Repeated Doses of IRL201104 in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE February 1, 2021
First Posted Date  ICMJE February 10, 2021
Last Update Posted Date April 26, 2021
Actual Study Start Date  ICMJE January 29, 2021
Actual Primary Completion Date April 5, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2021)
  • 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
  • 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
  • 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
  • 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.
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2021)
  • Pharmacokinetics of IRL201104: Trough blood concentration (Ctrough) [ Time Frame: 5 (group 1) or 7 (group 2) days ]
    Ctrough will be measured after multiple dosing
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2021)
  • Pharmacokinetics of IRL201104: Trough blood concentration (Ctrough) [ Time Frame: 5 (group 1) or 7 (group 2) days ]
    Ctrough will be measured after multiple dosing
  • PK of ILR201104: Maximum (peak) blood concentration (Cmax) [ Time Frame: 5 (group 1) or 7 (group 2) days ]
    Cmax will be calculated after multiple dosing
  • PK of ILR201104: Terminal half life (t1/2) [ Time Frame: 5 (group 1) or 7 (group 2) days ]
    t1/2 will be calculated after multiple dosing
  • 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
  • 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
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and PK of Repeated Doses of IRL201104 in Healthy Volunteers
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Healthy Volunteer
Intervention  ICMJE
  • Drug: IRL201104
    lyophilised powder for reconstitution for IV dosing
  • Drug: Placebo
    Matching placebo for IRL201104
Study Arms  ICMJE
  • Experimental: Group 1: Dose A IRL201104 or placebo
    IRL201104 IV once daily for 5 days OR Placebo IV once daily for 5 days
    Interventions:
    • Drug: IRL201104
    • Drug: Placebo
  • Experimental: Group 2: Dose B IRL201104 or placebo
    IRL201104 IV once daily for 7 days OR Placebo IV once daily for 7 days
    Interventions:
    • Drug: IRL201104
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 8, 2021)
18
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 5, 2021
Actual Primary Completion Date April 5, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04748536
Other Study ID Numbers  ICMJE C1104-003
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Revolo Biotherapeutics
Study Sponsor  ICMJE Revolo Biotherapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Revolo Biotherapeutics
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP