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
Completed · Phase 1 · Has a placebo group
Conditions studied: Healthy Subjects
In brief
The main objective of the study is to investigate the safety and tolerability of single ascending doses of AC-076 administered as subcutaneous injection
Key facts
- Study ID
- NCT03173625
- Run by
- Viatris Innovation GmbH
- People needed
- 72
- Starts
- 2016-11-29
- Expected to finish
- 2017-04-15
- Last updated by the study team
- 2025-07-02
Who can join
Age: 18 and older, up to 45. Sex: male. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Biotrial Inc. — Newark, New Jersey, United States
Full record on ClinicalTrials.gov
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