Safety, Tolerability, and Pharmacokinetics of IRL201104 in Healthy Volunteers
- Registration Number
- NCT05921591
- Lead Sponsor
- Revolo Biotherapeutics
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose C IRL201104 IRL201104 IRL201104 or placebo IV on days 1 and 7 Dose A IRL201104 Placebo IRL201104 or placebo IV on days 1 and 7 Dose B IRL201104 Placebo IRL201104 or placebo IV on days 1 and 7 Dose C IRL201104 Placebo IRL201104 or placebo IV on days 1 and 7 Dose B IRL201104 IRL201104 IRL201104 or placebo IV on days 1 and 7 Dose A IRL201104 IRL201104 IRL201104 or placebo IV on days 1 and 7
- Primary Outcome Measures
Name Time Method Treatment Emergent Adverse Events 28 days Number of subjects experiencing TEAE and number of TEAE will be summarised by treatment
- Secondary Outcome Measures
Name Time Method PK parameters of IRL201104 concentration in plasma 28 days Individual plasma levels will be listed and summarized by treatment and collection timepoint.
Trial Locations
- Locations (1)
Revolo Phase I site
🇺🇸Los Angeles, California, United States