Safety, Tolerability, and Pharmacokinetics of IRL201104 i... | NCT05921591

NCT05921591

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dose A IRL201104	Experimental	IRL201104 or placebo IV on days 1 and 7	Drug: IRL201104 Drug: Placebo
Dose B IRL201104	Experimental	IRL201104 or placebo IV on days 1 and 7	Drug: IRL201104 Drug: Placebo
Dose C IRL201104	Experimental	IRL201104 or placebo IV on days 1 and 7	Drug: IRL201104 Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
IRL201104	Drug	Lyophilised powder for reconstitution for IV dosing	Dose A IRL201104 Dose B IRL201104 Dose C IRL201104

Outcomes Module

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

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 Outcomes

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

Eligibility Module

Eligibility Criteria

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.