Phase 1, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study of Intravenous APL-2 in Healthy Volunteers
- Conditions
- Ischaemic strokeStroke - Ischaemic
- Registration Number
- ACTRN12616000700437
- Lead Sponsor
- Clinical Network Services Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 25
1.Healthy male or female,
2.Continuous non-smoker for at least 3 months prior to dosing.
3.Weigh more than or equal to 55 kg and less than or equal to 90 kg and have a Body Mass Index (BMI) of greater than or equal to 18.5 and less than or equal to 32.0 kg/m2.
4.Medically healthy with no clinically significant screening results as deemed by the principal investigator (PI).
5.Able to provide documentary evidence of vaccination with Neisseria menigitides types A, C, W, Y and B, Streptococcus pneumoniae (PCV13 or PPSV23) and Haemophilus influenza (Hib) within 2 years of dosing, or willing to receive vaccinations against Neisseria menigitides, PCV13 and Hib vaccines at least two weeks prior to dosing.
6.Women of child bearing potential (WOCBP) must have a negative pregnancy test at screening and during the study and must agree to use protocol defined methods of contraception for the duration of the study.
7.Women of non-childbearing potential (WONCBP) must have undergone one of the protocol defined sterilization procedures at least 6 months prior to dosing or be postmenopausal for at least 1 year prior to dosing and have FSH serum levels consistent with postmenopausal status upon Screening.
8.Males must agree to use protocol defined methods of contraception and agree to refrain from donating sperm for 3 months after the final dose of APL-2.
10.Willing and able to give informed consent.
1.Mental or legal incapacitation or significant emotional problems at screening or expected during the study in the opinion of the PI.
2.History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the principal investigator (PI).
3.History of any illness that, in the opinion of the PI, might confound the study results or poses an additional risk to the subject by their participation in the study.
4.History or presence of alcoholism or drug abuse within the past 2 years prior to screening.
5. History or presence of hypersensitivity or idiosyncratic reaction to compounds related to the investigational product.
6. History of chronic infections or active infection at check-in (as determined by the PI)
7.Pregnant or lactating women.
8.Positive results for the urine drug or alcohol breath test at screening or check-in.
9.Positive urine cotinine at screening or check in.
10.Positive results at screening for human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
11.Clinically relevant clinical laboratory results at screening or check in, as deemed by the PI.
12.Seated systolic blood pressure less than 90/40 mmHg or greater than 140/90 at screening or greater than 155/90 mmHg at any other assessment prior to dosing.
13.Heart rate lower than 40 bpm or higher than 99 bpm at screening or at any other assessment prior to dosing.
14.QTcF interval greater than 450 msec for males or greater than 470 msec for females, or history of prolonged QT syndrome at screening or prior to dosing.
15.Estimated creatinine clearance (CrCl) less than 90 mL/min (Cockcroft Gault formula)or serum creatinine greater than 1.5 mg/mL (133 µmol/L) at screening.
16. Unable to refrain from or anticipates the use of:
-Any drug, including prescription and non prescription medications, herbal remedies, or vitamin supplements from 14 days prior to dosing and throughout the study, with the exception of paracetamol.
-Any drugs known to be significant inducers of CYP enzymes and/or P gp, including St. John’s Wort, for 28 days prior to dosing and throughout the study.
17.Blood donation or significant blood loss within 56 days prior to dosing.
18.Plasma donation within 7 days prior to dosing.
19.Participation in another clinical trial within 28 days prior to dosing.
20.Clinically relevant surgery within 90 days prior to dosing..
21.Any condition or circumstance, in the opinion of the PI, which may make the subject unlikely to complete the study or comply with study procedures and requirements, or may pose a risk to the subject’s safety.
22.Subjects who have participated in the any study with APL-2.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method