Safety, Tolerability, and Pharmacokinetics of IRL201104 in Healthy Volunteers

Sponsor

Revolo Biotherapeutics (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05921591

Collaborator

(none)

Enrollment

Location

Arms

3.5

Anticipated Duration (Months)

6.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteer	Drug: IRL201104 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

May 26, 2023

Anticipated Primary Completion Date :

Sep 11, 2023

Anticipated Study Completion Date :

Sep 11, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Dose A IRL201104

IRL201104 or placebo IV on days 1 and 7

Drug: IRL201104

Lyophilised powder for reconstitution for IV dosing

Drug: Placebo

Matching placebo for IRL201104

Experimental: Dose B IRL201104

IRL201104 or placebo IV on days 1 and 7

Drug: IRL201104

Lyophilised powder for reconstitution for IV dosing

Drug: Placebo

Matching placebo for IRL201104

Experimental: Dose C IRL201104

IRL201104 or placebo IV on days 1 and 7

Drug: IRL201104

Lyophilised powder for reconstitution for IV dosing

Drug: Placebo

Matching placebo for IRL201104

Outcome Measures

Primary Outcome Measures

Treatment Emergent Adverse Events [28 days]
Number of subjects experiencing TEAE and number of TEAE will be summarised by treatment

Secondary Outcome Measures

PK parameters of IRL201104 concentration in plasma [28 days]
Individual plasma levels will be listed and summarized by treatment and collection timepoint.

Other Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Revolo Phase I site	Los Angeles	California	United States	90630

Sponsors and Collaborators

Revolo Biotherapeutics

Investigators

Study Director: Anoshie Ratnayake, MD, MPH, Revolo Biotherapeutics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Revolo Biotherapeutics

ClinicalTrials.gov Identifier:

NCT05921591

Other Study ID Numbers:

RVLO 111-06

First Posted:

Jun 27, 2023

Last Update Posted:

Jun 27, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jun 27, 2023