ACTRN12616000862448
Terminated
Phase 1
Phase 1, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study of Subcutaneous APL-9 in Healthy Volunteers
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Paroxysmal nocturnal hemoglobinuria (PNH)
- Sponsor
- Clinical Network Services Pty Ltd
- Enrollment
- 6
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Medically healthy adults
- •Weigh more than 50 kg and less than 95 kg and have a BMI higher than 18\.0 kg/m2 and lower than 32\.0 kg/m2\.
- •Have been vaccinated against Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus influenza 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 60 days or participation in any previous clinical trial with APL\-9\.
- •Female subjects who are pregnant or lactating.
Outcomes
Primary Outcomes
Not specified
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