Healthy Subjects
Conditions
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
Interventions
DRUGAC-076 for s.c. administration
Lyophilized AC-076A to be reconstituted with 1 mL of water for injection
DRUGPlacebo
Sterile 0.9% w/v sodium chloride solution
Sponsors
Viatris Innovation GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 PRU |
| Area 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 |
| 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 |
| 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 |
Countries
United States
Outcome results
None listed