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

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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


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
We found this trial at
1
site
130 Norfolk Street
Newark, New Jersey 07103
?
mi
from
Newark, NJ
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