Safety and PK of Repeated Doses of IRL201104 in Healthy Volunteers

NCT ID: NCT04748536

Last Updated: 2021-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-29
• Study Completion Date: 2021-04-05

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group 1: Dose A IRL201104 or placebo

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

Group Type: EXPERIMENTAL

IRL201104

Intervention Type: DRUG

lyophilised powder for reconstitution for IV dosing

Placebo

Intervention Type: DRUG

Matching placebo for IRL201104

Group 2: Dose B IRL201104 or placebo

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

Group Type: EXPERIMENTAL

IRL201104

Intervention Type: DRUG

lyophilised powder for reconstitution for IV dosing

Placebo

Intervention Type: DRUG

Matching placebo for IRL201104

Interventions

IRL201104

lyophilised powder for reconstitution for IV dosing

Intervention Type: DRUG

Placebo

Matching placebo for IRL201104

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Revolo Biotherapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hammersmith Medicines Research

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

C1104-003

Identifier Type: -

Identifier Source: org_study_id