Safety, Tolerability, and Pharmacokinetics of IRL201104 in Healthy Volunteers

Healthy Volunteer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05921591
• Other study ID #: RVLO 111-06
• Status: Completed
• Phase: Phase 1
• Start date: May 26, 2023
• Est. completion date: September 12, 2023

Study information

• Verified date: September 2023
• Source: Revolo Biotherapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 12, 2023
• Est. primary completion date: September 12, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• IRL201104
Lyophilised powder for reconstitution for IV dosing
• Placebo
Matching placebo for IRL201104

Locations

Country	Name	City	State
United States	Revolo Phase I site	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Revolo Biotherapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Treatment Emergent Adverse Events	Number of subjects experiencing TEAE and number of TEAE will be summarised by treatment	28 days
Secondary	PK parameters of IRL201104 concentration in plasma	Individual plasma levels will be listed and summarized by treatment and collection timepoint.	28 days