Safety, Tolerability, and Pharmacokinetics of IRL201104 in Healthy Volunteers

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: Placebo; Drug: IRL201104

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90630
      • Revolo Phase I site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose A IRL201104; IRL201104 or placebo IV on days 1 and 7	Drug: Placebo; Matching placebo for IRL201104; Drug: IRL201104; Lyophilised powder for reconstitution for IV dosing
Experimental: Dose B IRL201104; IRL201104 or placebo IV on days 1 and 7	Drug: Placebo; Matching placebo for IRL201104; Drug: IRL201104; Lyophilised powder for reconstitution for IV dosing
Experimental: Dose C IRL201104; IRL201104 or placebo IV on days 1 and 7	Drug: Placebo; Matching placebo for IRL201104; Drug: IRL201104; Lyophilised powder for reconstitution for IV dosing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Emergent Adverse Events	Number of subjects experiencing TEAE and number of TEAE will be summarised by treatment	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK parameters of IRL201104 concentration in plasma	Individual plasma levels will be listed and summarized by treatment and collection timepoint.	28 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of treatment-emergent anti-drug antibody (ADA) responses	The presence of ADAs to IRL201104 will be listed and summarized by treatment group and timepoint.	28 days

Collaborators and Investigators

• Sponsor: Revolo Biotherapeutics
• Investigators: Study Director: Anoshie Ratnayake, MD, MPH, Revolo Biotherapeutics

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2023
• Primary Completion (Actual): September 12, 2023
• Study Completion (Actual): September 12, 2023

Study Registration Dates

• First Submitted: May 23, 2023
• First Submitted That Met QC Criteria: June 19, 2023
• First Posted (Actual): June 27, 2023

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: RVLO 111-06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No