A Phase I, Single-Dose, Open-Label Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of APL-2

Phase 1

Completed

• Conditions: Kidney Disease; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12617000822381
• Lead Sponsor: Clinical Network Services Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-05
• Study Completion: 2018-04-06
• Last Update Posted: 19 October 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

All Subjects:
1.Body mass index (BMI) greater than or equal to 18.5 and less than or equal to 36.0 kg/m2
2.Willingness to utilize an approved form of contraception

Cohort 1 (Severe Renal Impaired Subjects):
1.Screening CLCR <30 mL/min
2.Supine blood pressure less than or equal to 190/105 mmHg
3.Stable renal function

Cohort 2 (Matched Control Group):
1..Screening CLCR greater than or equal to 60 mL/min
2.Supine blood pressure less than or equal to 160/95 mmHg

Each subject in Cohort 2 will be matched with an individual subject in Cohort 1.

Exclusion Criteria

1.Acute renal failure.
2.History of renal transplant
3.Dialysis or hemofiltration
4.Clinically significant disease or illness (other than renal impairment)
5.Febrile illness/infection within 21 days prior to dosing
6.Human immunodeficiency virus; hepatitis B virus, and/or hepatitis C virus
7.Pregnancy, or lactating/breastfeeding

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum concentrations of APL-2[Baseline and at 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 240, 336, 408, 504, 576, 672, and 1,008 hours after dosing.]

Secondary Outcome Measures

Name	Time	Method
Serum concentrations of C3.<br>The complement cascade is part of the immune system, responsible for killing bacteria that infect the body. Complement component C3 is a protein that plays a key role in activation of the complement cascade. [Baseline and at 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 240, 336, 408, 504, 576, 672, and 1,008 hours after dosing.];The number and severity of treatment emergent adverse events (TEAEs) following administration of single subcutaneous dose of APL-2.[Baseline and at 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 240, 336, 408, 504, 576, 672, and 1,008 hours after dosing.]