Safety, Tolerability, and Pharmacokinetics of IRL201104 in Healthy Volunteers

Study Overview
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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.

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

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: IRL201104
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 |