Safety, Tolerability, and Pharmacokinetics of IRL201104 in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-26

Study Completion Date

2023-09-12

Brief Summary

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

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Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dose A IRL201104

IRL201104 or placebo IV on days 1 and 7

Group Type EXPERIMENTAL

IRL201104

Intervention Type DRUG

Lyophilised powder for reconstitution for IV dosing

Placebo

Intervention Type DRUG

Matching placebo for IRL201104

Dose B IRL201104

IRL201104 or placebo IV on days 1 and 7

Group Type EXPERIMENTAL

IRL201104

Intervention Type DRUG

Lyophilised powder for reconstitution for IV dosing

Placebo

Intervention Type DRUG

Matching placebo for IRL201104

Dose C IRL201104

IRL201104 or placebo IV on days 1 and 7

Group Type EXPERIMENTAL

IRL201104

Intervention Type DRUG

Lyophilised powder for reconstitution for IV dosing

Placebo

Intervention Type DRUG

Matching placebo for IRL201104

Interventions

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IRL201104

Lyophilised powder for reconstitution for IV dosing

Intervention Type DRUG

Placebo

Matching placebo for IRL201104

Intervention Type DRUG

Eligibility Criteria

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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 .

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes