A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of IRL201104 in Healthy Volunteers

Revolo Biotherapeutics1 site in 1 country24 target enrollmentStarted: May 26, 2023Last updated: September 28, 2023

Conditions

Interventions

Drugs

Trial Snapshot

Phase: Phase 1
Status: Completed
Sponsor: Revolo Biotherapeutics
Enrollment: 24
Locations: 1
Primary Endpoint: Treatment Emergent Adverse Events

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

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

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Sequential
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages: 18 Years to 55 Years (Adult)
Sex: All
Accepts Healthy Volunteers: Yes

Inclusion Criteria

•Participants must provide signed informed consent.
•Participants must be in good general health.
•Body mass index (BMI) 18 to ≤ 30 kg/m
•Contraception use by men or women .

Exclusion Criteria

•Clinically significant liver, kidney disease or cardiac disease.
•Active malignancy and/or history of malignancy in the past 5 years.
•Serious local or systemic infection within 30 days prior to Screening
•Any acute illness within 30 days prior to Day
•Surgery, bone fracture or major musculoskeletal injury within the 3 months.
•Abnormal screening laboratory tests.
•Positive for human immunodeficiency virus (HIV) antibody or antigen.
•Positive hepatitis C virus (HCV) antibody or positive hepatitis B surface antigen (HBsAg).
•Positive result indicating active SARS-CoV-2 infection on Day -
•Positive urine drug screen/alcohol breath test at Screening.
•Positive Quantiferon Tuberculosis (TB) test.
•Systolic blood pressure (BP) > 150 mmHg or < 90 mmHg or diastolic BP > 90 mmHg or < 50 mmHg. Heart rate < 40 beats per minute (bpm) or > 100 bpm.
•Prolonged QT interval corrected by Fridericia's formula (QTcF) (> 450 ms for males and > 470 ms for females), cardiac arrhythmia, or any clinically significant abnormality in the resting electrocardiogram (ECG), as judged by the Investigator.
•All prescription and over-the-counter medications (including herbal medications), except for contraceptives and hormonal replacement therapy (HRT), are prohibited within 7 days prior to the first study intervention administration and throughout the entire duration of the study.
•All vaccines within 30 days prior and throughout the entire duration of the study.
•Administration of investigational product in another study within 30 days prior to the first study intervention administration, or five half-lives, whichever is longer.
•Blood donation within 30 days prior to the first study intervention administration.
•Females who are pregnant or breastfeeding.
•Failure to satisfy Investigator of fitness to participate for any other reason.
•Cigarette smokers and users of nicotine-containing products.