A Study Conducted in Healthy Male Subjects to Investigate the Safety and Tolerability of AC-76, Its Fate in the Body, and Its Effect on the Body
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 45 |
Updated: | 7/12/2018 |
Start Date: | November 29, 2016 |
End Date: | April 15, 2017 |
Single-center, Double-blind, Placebo-controlled, Randomized, Single-ascending Dose Study to Investigate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics of AC-076 in Healthy Male Subjects
The main objective of the study is to investigate the safety and tolerability of single
ascending doses of AC-076 administered as subcutaneous injection
ascending doses of AC-076 administered as subcutaneous injection
Inclusion Criteria:
- Signed informed consent
- Body mass index (BMI) of 18.0 to 31.0 kg/m2 (inclusive) at screening
- Systolic blood pressure (SBP) 100-145 mmHg, diastolic blood pressure (DBP) 50-90 mmHg,
and pulse rate 45-90 beats per minute (inclusive) at screening
- Healthy on the basis of physical examination, electrocardiogram and laboratory tests
- Maximum (at peak) platelet aggregation ≥ 40%
- Values of closure time tested with the Platelet Function Analyzer (PFA) equipment, for
both cartridges of collagen/epinephrine and collagen/ADP below the upper limit of
normal range at screening
Exclusion Criteria:
- Known hypersensitivity to AC-076 or drugs of the same class, or any of their
excipients
- Family or personal history of prolonged bleeding or bleeding disorders, intracranial
vascular diseases, stroke, reasonable suspicion of vascular malformations, or peptic
ulcers
- Platelet count < 120 × 109 L-1 at screening
- Known platelet disorders
- Orthostatic hypotension at screening (i.e., decrease from supine to standing BP of >
20 mmHg in SBP or > 10 mmHg in DBP after being in standing position for 3 min)
- Previous treatment with acetylsalicylate, non-steroidal anti-inflammatory drugs or any
medication with blood thinning activity within 3 weeks prior to study drug
administration; or with any other prescribed medications (including vaccines) or over
the counter medications within 2 weeks prior to study drug administration
- Any circumstances or conditions, which, in the opinion of the investigator, may affect
full participation in the study or compliance with the protocol
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