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

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

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 Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: AC-076 for s.c. administration; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Newark, New Jersey, United States, 07103
      • Biotrial Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AC-076 sc administration - single ascending dose; 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)	Drug: AC-076 for s.c. administration; Lyophilized AC-076A to be reconstituted with 1 mL of water for injection
Placebo Comparator: Placebo; For each AC-076 dose level tested, 2 healthy male subjects will receive matching placebo in the same condition	Drug: Placebo; Sterile 0.9% w/v sodium chloride solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.; IPA PRU	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	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

Collaborators and Investigators

• Sponsor: Viatris Innovation GmbH
• Investigators: Study Director: Clinical Trials, Viatris Innovation GmbH

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2016
• Primary Completion (Actual): April 15, 2017
• Study Completion (Actual): April 15, 2017

Study Registration Dates

• First Submitted: May 23, 2017
• First Submitted That Met QC Criteria: May 30, 2017
• First Posted (Actual): June 2, 2017

Study Record Updates

• Last Update Posted (Actual): July 2, 2025
• Last Update Submitted That Met QC Criteria: July 1, 2025
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: AC-076-102