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The main objective of the study is to investigate the safety and tolerability of single ascending doses of AC-076 administered as subcutaneous injection
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AC-076 sc administration - single ascending dose | Experimental | 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) |
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| Placebo | Placebo Comparator | For each AC-076 dose level tested, 2 healthy male subjects will receive matching placebo in the same condition |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AC-076 for s.c. administration | Drug | Lyophilized AC-076A to be reconstituted with 1 mL of water for injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | Treatment-emergent AEs and treatment-emergent serious AEs | 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 | From study treatment administration up to day 3 |
| Changes from baseline in supine blood pressure | Supine blood pressure (mmHg) | From study treatment administration up to day 3 |
| Changes from baseline in pulse rate | Pulse rate (bpm) | From study treatment administration up to day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| 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.
| From baseline up to day 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Viatris Innovation GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biotrial Inc. | Newark | New Jersey | 07103 | United States |
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| Placebo | Drug | Sterile 0.9% w/v sodium chloride solution |
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| Maximum plasma concentration (Cmax) of AC-076 |
Cmax of AC-076 will be derived by non-compartmental analysis of the plasma concentration-time profile |
| 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 | From baseline up to day 3 |
| terminal half-life (t1/2) | t1/2 of AC-076 will be derived by non-compartmental analysis of the plasma concentration-time profile | 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 | 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 | From baseline up to day 3 |