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
- Conditions
- Healthy Subjects
- Interventions
- Drug: AC-076 for s.c. administrationDrug: Placebo
- Registration Number
- NCT03173625
- Lead Sponsor
- Viatris Innovation GmbH
- Brief Summary
The main objective of the study is to investigate the safety and tolerability of single ascending doses of AC-076 administered as subcutaneous injection
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 72
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AC-076 sc administration - single ascending dose AC-076 for s.c. administration On Day 1, 48 subjects will receive AC-076 at different single dose levels in a sequential manner and in a maximum of 6 dose levels, starting from 1 mg. Subjects will be followed by an observation period of 48 h. Each dose level will be investigated in a new group of 8 healthy male subjects (6 on active drug and 2 on placebo) Placebo Placebo For each AC-076 dose level tested, 2 healthy male subjects will receive matching placebo in the same condition
- Primary Outcome Measures
Name Time Method Number of participants with adverse events (AEs) From study treatment administration up to day 3 Treatment-emergent AEs and treatment-emergent serious AEs
Changes from baseline in electrocardiogram (ECG) variables From study treatment administration up to day 3 ECG variables are to be recorded at rest using a standard 12-lead ECG
Changes from baseline in supine blood pressure From study treatment administration up to day 3 Supine blood pressure (mmHg)
Changes from baseline in pulse rate From study treatment administration up to day 3 Pulse rate (bpm)
- Secondary Outcome Measures
Name Time Method Maximum plasma concentration (Cmax) of AC-076 From baseline up to day 3 Cmax of AC-076 will be derived by non-compartmental analysis of the plasma concentration-time profile
time to reach Cmax (tmax) From baseline up to day 3 tmax of AC-076 will be derived by non-compartmental analysis of the plasma concentration-time profile
Measurement of inhibition of platelet aggregation (IPA) using anticoagulant assays From baseline up to day 3 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 PRUArea under the plasma concentration-time curves from time 0 to inf [AUC(0-inf)] From baseline up to day 3 AUC(0-inf) of AC-076 will be derived by non-compartmental analysis of the plasma concentration-time profile
Area under the plasma concentration-time curves during a dosing interval [AUC(0-t)] of From baseline up to day 3 AUC(0-t) of AC-076 will be derived by non-compartmental analysis of the plasma concentration-time profile
terminal half-life (t1/2) From baseline up to day 3 t1/2 of AC-076 will be derived by non-compartmental analysis of the plasma concentration-time profile
Trial Locations
- Locations (1)
Biotrial Inc.
🇺🇸Newark, New Jersey, United States
Biotrial Inc.🇺🇸Newark, New Jersey, United States