Phase I, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study of Intravenous APL-9 in Healthy Volunteers

Phase 1

Completed

• Conditions: Ischaemic stroke; Stroke - Ischaemic

• Registration Number: ACTRN12617001308381
• 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: 2017-09-12
• Study Completion: 2019-01-08
• Last Update Posted: 3 August 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Medically healthy adults
Weigh more than 55 kg and less than 90 kg and have a BMI higher than 18.5 kg/m2 and lower than 32.0 kg/m2.
Have been vaccinated against Neisseria meningitidis within two years or willing to receive vaccinations.

Exclusion Criteria

Mentally or legally incapacitated or has significant emotional problems or has a history of a significant medical or psychiatric condition or a history of hypersensitivity to compounds related to APL-9 or a history of chronic infections or a recent active infection or recent surgery.
Use of any prescription or non-prescription medications, herbal remedies, or vitamin supplements within the last 14 days
Blood donation or significant blood loss within previous 56 days or plasma donation within previous 7 days
Participation in another clinical trial within the previous 28 days or participation in any previous clinical trial with APL-9.

Female subjects who are pregnant or lactating.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The safety and tolerability of single intraveneous doses of APL-9 when administered to healthy adults. [Throughout the study, routine clinical tests will be conducted, including vital signs, ECGs, and blood and urine tests.<br>Vital signs will be recorded at screening, upon check-in to the clinic on the day before dosing; during dosing on Day 1; at 1, 2, 4, 8 and 12 hours after dosing on Day 1, and then once per day on Day 2, 3, 4, 5, 6, 7, 8, 11, 15, 29, and 43. ECGs will be recorded at screening, upon check-in to the clinic on the day before dosing on Day 1; before dosing; at 1, 2, 4, 8 and 12 hours after dosing on Day 1, and then once per day on Day 2, 3, 4, 5, 6, 7, 8, 11, 15, 29, and 43.<br>Blood and urine samples will be collected for testing at screening, upon check-in to the clinic on the day before dosing. then on Day 2, 4, 8, 15, 29, and 43.]

Secondary Outcome Measures

Name	Time	Method
Serum pharmacokinetics of single subcutaneous doses of APL-9 when administered to healthy adults. AUC, Cmax, tmax, CL/F, VZ/F and t1/2 will be determined.[Blood will be collected for serum APL-9 measurements before dosing; at 15 and 30 minutes and 1, 1.5, 2, 3, 4, 8 and 12 hours post-dosing on Day 1, and then once per day on Day 2, 3, 4, 5, 6, 7, 8, 11 and 15. ];Serum pharmacodynamics of single subcutaneous doses of APL-9 when administered to healthy adults, AH50, CH50, C3 and C3a will be measured. [Blood will be collected for serum complement activation marker measurements at screening; before dosing; at 1, 2, 4, 8 and 12 hours after dosing on Day 1, and then once per day on Day 2, 3, 4, 5, 6, 7, 8, 11, 15, 18, 22,25, 29, and 43. ]