A Study of CSL112 in Healthy Adults and in Adults With Moderate Renal Impairment

CSL Behring

Status and phase: Completed; Phase 1

Conditions: Acute Myocardial Infarction

Treatments: Biological: CSL112; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02427035

CSL112_1001

2014-005520-10 (EudraCT Number)

Details and patient eligibility

About

This is a phase 1 multicenter, randomized, double-blind, placebo-controlled, ascending dose study to investigate the pharmacokinetics (PK), safety, and tolerability of CSL112 in adult subjects with moderate renal impairment and in healthy adult subjects with normal renal function.

Enrollment: 32 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men or women aged 18 to 85 years (inclusive) of age, with body weight 50 kg or more.
• Subjects with renal impairment (RI) must have stable chronic moderate RI (estimated glomerular filtration rate [eGFR] ≥ 30 and < 60 mL/min/1.73 m2)
• Healthy subjects must have normal renal function (eGFR ≥ 90 mL/min/1.73 m2)

Exclusion criteria

• Evidence of a clinically significant medical condition, disorder or disease
• Evidence of hepatobiliary disease
• Any clinically relevant abnormal laboratory test result
• Known history of allergies, hypersensitivity or deficiencies to CSL112 or any of its components
• Other severe comorbid condition, concurrent medication, or other issue that renders the subject unsuitable for participation in the study, including: history of cancer, low platelet count, bleeding disorder or coagulopathy, significantly altered electrocardiogram waveform, unstable glycemia control in subjects with diabetes, acute renal failure, recent donation or loss of blood
• Evidence or history of alcohol or substance abuse

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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32 participants in 2 patient groups

Low

Experimental group

Description:

A low dose of either CSL112 or placebo is to be administered as a single intravenous (IV) infusion. The placebo will be administered at the same frequency, volume and duration as the CSL112 infusion.

Treatment:

Biological: CSL112

Other: Placebo

High

Experimental group

Description:

A high dose of either CSL112 or placebo is to be administered as a single intravenous (IV) infusion. The placebo will be administered at the same frequency, volume and duration as the CSL112 infusion.

Treatment:

Biological: CSL112

Other: Placebo