Safety and PK of Repeated Doses of IRL201104 in Healthy Volunteers

NCT04748536 | Completed Phase 1

• 1 other identifier: C1104-003
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (6)

• Pharmacokinetics of IRL201104: Trough blood concentration (Ctrough)

  5 (group 1) or 7 (group 2) days

• PK of IRL201104: Maximum (peak) blood concentration (Cmax)

  5 (group 1) or 7 (group 2) days

• PK of IRL201104: Terminal half life (t1/2)

  5 (group 1) or 7 (group 2) days

• 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

• PK of IRL201104: Apparent total body clearance from blood (CLss)

  5 (group 1) or 7 (group 2) days

Study Arms (2)

Group 1: Dose A IRL201104 or placebo

EXPERIMENTAL

IRL201104 IV once daily for 5 days OR Placebo IV once daily for 5 days

Drug: IRL201104; Drug: Placebo

Group 2: Dose B IRL201104 or placebo

EXPERIMENTAL

IRL201104 IV once daily for 7 days OR Placebo IV once daily for 7 days

Drug: IRL201104; Drug: Placebo

Interventions

IRL201104 DRUG

lyophilised powder for reconstitution for IV dosing

Group 1: Dose A IRL201104 or placebo; Group 2: Dose B IRL201104 or placebo

Placebo DRUG

Matching placebo for IRL201104

Group 1: Dose A IRL201104 or placebo; Group 2: Dose B IRL201104 or placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Revolo Biotherapeutics: lead

Study Sites (1)

Hammersmith Medicines Research

London, United Kingdom

Location

MeSH Terms

Interventions

IRL201104

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 10, 2021
• Study Start: January 29, 2021
• Primary Completion: April 5, 2021
• Study Completion: April 5, 2021
• Last Updated: April 26, 2021

Record last verified: 2021-02

Locations

GB (1)