Phase I, Double-Blind, Randomized Study of Daily, Twice-Weekly and Once-Weekly APL 2 in Healthy Volunteers
Phase of Trial: Phase I
Latest Information Update: 30 Sep 2017
At a glance
- Drugs APL 2 (Primary)
- Indications Dry age-related macular degeneration; Ischaemia; Paroxysmal nocturnal haemoglobinuria; Wet age-related macular degeneration
- Focus Adverse reactions; Pharmacokinetics
- 28 Sep 2017 An extra subject will receive placebo in Cohort 3 to allow for Sentinel subjects (1 active and 1 placebo) to be dosed a day ahead of the remaining subjects in Cohort 3 (3 active and 1 placebo), yet still maintain the blind. The Sentinel subjects will be included in Cohort 3 as an additional safety precaution, because the planned dose of APL 2 (2,600 mg once per week) is higher than the highest single dose administered to date (1,440 mg). and Blood and urine samples will be collected on D
- 28 Sep 2017 Planned number of patients changed from 20 to 22.
- 28 Sep 2017 Planned End Date changed from 30 Apr 2018 to 31 Aug 2018.