Clinical trial NCT05921591: Safety, Tolerability, and Pharmacokinetics of IRL201104 in Healthy Volunteers
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of IRL201104 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Revolo Biotherapeutics
Sponsor class: INDUSTRY
First posted: 2023-06-27
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Treatment Emergent Adverse Events
timeFrame: 28 days
Secondary outcomes:
measure: PK parameters of IRL201104 concentration in plasma
timeFrame: 28 days
Other outcomes:
measure: Incidence of treatment-emergent anti-drug antibody (ADA) responses
timeFrame: 28 days
Locations:
city: Los Angeles
country: United States
facility: Revolo Phase I site
state: California
Study officials:
affiliation: Revolo Biotherapeutics
name: Anoshie Ratnayake, MD, MPH
role: STUDY_DIRECTOR
References: