The main objective of the study is to investigate the safety and tolerability of single ascending doses of AC-076 administered as subcutaneous injection
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
72
Lyophilized AC-076A to be reconstituted with 1 mL of water for injection
Sterile 0.9% w/v sodium chloride solution
Biotrial Inc.
Newark, New Jersey, United States
Number of participants with adverse events (AEs)
Treatment-emergent AEs and treatment-emergent serious AEs
Time frame: From study treatment administration up to day 3
Changes from baseline in electrocardiogram (ECG) variables
ECG variables are to be recorded at rest using a standard 12-lead ECG
Time frame: From study treatment administration up to day 3
Changes from baseline in supine blood pressure
Supine blood pressure (mmHg)
Time frame: From study treatment administration up to day 3
Changes from baseline in pulse rate
Pulse rate (bpm)
Time frame: From study treatment administration up to day 3
Measurement of inhibition of platelet aggregation (IPA) using anticoagulant assays
Maximum (MPA) and final (FPA) platelet aggregation using light transmission aggregometry (LTA) assay. % inhibition of platelet aggregation (IPA), MPA and FPA. P2Y12 reaction units (PRU) using the VerifyNow P2Y12 assay. * IPA PRU
Time frame: From baseline up to day 3
Maximum plasma concentration (Cmax) of AC-076
Cmax of AC-076 will be derived by non-compartmental analysis of the plasma concentration-time profile
Time frame: From baseline up to day 3
time to reach Cmax (tmax)
tmax of AC-076 will be derived by non-compartmental analysis of the plasma concentration-time profile
Time frame: From baseline up to day 3
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terminal half-life (t1/2)
t1/2 of AC-076 will be derived by non-compartmental analysis of the plasma concentration-time profile
Time frame: From baseline up to day 3
Area under the plasma concentration-time curves during a dosing interval [AUC(0-t)] of
AUC(0-t) of AC-076 will be derived by non-compartmental analysis of the plasma concentration-time profile
Time frame: From baseline up to day 3
Area under the plasma concentration-time curves from time 0 to inf [AUC(0-inf)]
AUC(0-inf) of AC-076 will be derived by non-compartmental analysis of the plasma concentration-time profile
Time frame: From baseline up to day 3