Safety, Tolerability, and Pharmacokinetics of IRL201104 in Healthy Volunteers

Revolo Biotherapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: IRL201104; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05921591

RVLO 111-06

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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24 participants in 3 patient groups

Dose A IRL201104

Experimental group

Description:

IRL201104 or placebo IV on days 1 and 7

Treatment:

Drug: IRL201104

Drug: Placebo

Dose B IRL201104

Experimental group

Description:

IRL201104 or placebo IV on days 1 and 7

Treatment:

Drug: IRL201104

Drug: Placebo

Dose C IRL201104

Experimental group

Description:

IRL201104 or placebo IV on days 1 and 7

Treatment:

Drug: IRL201104

Drug: Placebo