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Completed

NCT Number: NCT03173625

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

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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Key information

Conditions

Healthy Subjects

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Biotrial Inc.

Newark, New Jersey, 07103, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AC-076 for s.c. administration

Drug

Lyophilized AC-076A to be reconstituted with 1 mL of water for injection

Placebo

Drug

Sterile 0.9% w/v sodium chloride solution

Primary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: From study treatment administration up to day 3

    Treatment-emergent AEs and treatment-emergent serious AEs

  2. Changes from baseline in electrocardiogram (ECG) variables

    Time frame: From study treatment administration up to day 3

    ECG variables are to be recorded at rest using a standard 12-lead ECG

  3. Changes from baseline in supine blood pressure

    Time frame: From study treatment administration up to day 3

    Supine blood pressure (mmHg)

  4. Changes from baseline in pulse rate

    Time frame: From study treatment administration up to day 3

    Pulse rate (bpm)

Secondary outcomes

  1. Measurement of inhibition of platelet aggregation (IPA) using anticoagulant assays

    Time frame: 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

  2. Maximum plasma concentration (Cmax) of AC-076

    Time frame: From baseline up to day 3

    Cmax of AC-076 will be derived by non-compartmental analysis of the plasma concentration-time profile

  3. time to reach Cmax (tmax)

    Time frame: From baseline up to day 3

    tmax of AC-076 will be derived by non-compartmental analysis of the plasma concentration-time profile

  4. terminal half-life (t1/2)

    Time frame: From baseline up to day 3

    t1/2 of AC-076 will be derived by non-compartmental analysis of the plasma concentration-time profile

  5. Area under the plasma concentration-time curves during a dosing interval [AUC(0-t)] of

    Time frame: 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

  6. Area under the plasma concentration-time curves from time 0 to inf [AUC(0-inf)]

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Viatris Innovation GmbH

Industry

Registry information

Official study title

Single-center, Double-blind, Placebo-controlled, Randomized, Single-ascending Dose Study to Investigate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics of AC-076 in Healthy Male Subjects

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 2, 2017
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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