Acute Myocardial Infarction

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

NCT02427035 | PHASE 1 | INTERVENTIONAL

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.

4 Sites

32 Participants

Recruiting

18 Years to 85 Years

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SUBMIT

Study Site

Berlin,Germany,13353

Study Site

Munich,Germany,D-81241

Study Site

London,United Kingdom,SE11YR

Study Site

Manchester,United Kingdom,M139WL

Study Eligibility Criteria

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

Additional Studies

Additional studies can be found at ClinicalTrials.gov