A Study to Assess the effect of once-daily Subcutaneous APL-2 in Healthy Adult Subjects
- Conditions
- Paroxysmal nocturnal hemoglobinuria (PNH)Blood - Haematological diseases
- Registration Number
- ACTRN12614001299695
- Lead Sponsor
- Clinical Network Services (CNS) Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 20
Healthy adult male or female subject; body mass index (BMI) greater than or equal to 18.5 and less than or equal to 32.0 (kg/m2); weight greater than or equal to 60.0 kg and less than or equal to 80.0 kg
* Subject is mentally or legally incapacitated or has significant emotional problems; or has a history of: clinically significant medical or psychiatric condition or disease, any illness that might confound the results of the study or pose a risk to the subject by their participation in the study, alcoholism or drug abuse, and/or hypersensitivity or idiosyncratic reaction to compounds related to APL-2 or particular antibiotics.
* Subject has a history of chronic infections (eg COPD) or any active infection
* Female subjects who are pregnant or lactating.
* Use of any prescription and non-prescription medications, herbal remedies, or vitamin supplements within the last 14 days, or use of some particular drugs such as St. John’s Wort within the last 28 days, up until the end of the study (paracetamol may be permitted)
* Blood donation or significant blood loss within the past 56 days or plasma donation within the last 7 days.
* Participation in another clinical trial within the past 28 days
* Significant surgery within the past 90 days
* Presence of any scars or tattoos on the abdomen which may obscure the injection site
* Subjects who have participated in the Single Ascending Dose study with APL-2
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The safety and tolerability of multiple subcutaneous doses of APL-2 when administered to healthy adult subjects.<br>Throughout the study, routine clinical tests will be conducted, including vital signs, ECGs, and blood and urine tests.[1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 42, 56, 70, and 84 days after treatment]
- Secondary Outcome Measures
Name Time Method Pharmacokinetics of multiple subcutaneous doses of APL-2 when administered to healthy adult subjects.<br><br><br>[Serum APL-2 1, 2, 3, 4, 5, 6, 8, 15, 22, 28, 29, 35, 42, 56, 70, and 84 days after treatment];Pharmacodynamics of multiple subcutaneous doses of APL-2 when administered to healthy adult subjects.[Serum complement activation markers 8, 15, 22, 29, 35, 42, 56, 70, and 84 days after treatment]