NCT02427035

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

A Double-blind, Randomized, Placebo-controlled, Pharmacokinetic, Safety and Tolerability Study of CSL112 in Adult Subjects With Moderate Renal Impairment and in Healthy Adult Subjects With Normal Renal Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: CSL Behring · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Acute Myocardial Infarction

Interventions

Type	Name	Description
BIOLOGICAL	CSL112	CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles.
OTHER	Placebo	0.9% weight/volume sodium chloride solution (ie, normal saline)

Timeline

• Start date: 2015-05-01
• Primary completion: 2015-11-01
• Completion: 2016-02-01
• First posted: 2015-04-27
• Last updated: 2017-09-19

Locations

4 sites across 2 countries: Germany, United Kingdom