Healthy Volunteer
Conditions
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.
Interventions
DRUGIRL201104
Lyophilised powder for reconstitution for IV dosing
DRUGPlacebo
Matching placebo for IRL201104
Sponsors
Revolo Biotherapeutics
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * Participants must provide signed informed consent. * Participants must be in good general health. * Body mass index (BMI) 18 to ≤ 30 kg/m2. * Contraception use by men or women . Key
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 1. * 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 -1. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Emergent Adverse Events | 28 days | Number of subjects experiencing TEAE and number of TEAE will be summarised by treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK parameters of IRL201104 concentration in plasma | 28 days | Individual plasma levels will be listed and summarized by treatment and collection timepoint. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment-emergent anti-drug antibody (ADA) responses | 28 days | The presence of ADAs to IRL201104 will be listed and summarized by treatment group and timepoint. |
Countries
United States
Outcome results
None listed