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

NCT03173625 | Completed Phase 1

• 1 other identifier: AC-076-102
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Measurement of inhibition of platelet aggregation (IPA) using anticoagulant assays

  From baseline up to day 3

• Maximum plasma concentration (Cmax) of AC-076

  From baseline up to day 3

• time to reach Cmax (tmax)

  From baseline up to day 3

• terminal half-life (t1/2)

  From baseline up to day 3

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

  From baseline up to day 3

Study Arms (2)

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)

Drug: AC-076 for s.c. administration

Placebo

PLACEBO COMPARATOR

For each AC-076 dose level tested, 2 healthy male subjects will receive matching placebo in the same condition

Drug: Placebo

Interventions

AC-076 for s.c. administration DRUG

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

AC-076 sc administration - single ascending dose

Placebo DRUG

Sterile 0.9% w/v sodium chloride solution

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Viatris Innovation GmbH: lead

Study Sites (1)

Biotrial Inc.

Newark, New Jersey, 07103, United States

Location

Study Officials

• Clinical Trials

  Viatris Innovation GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2017
• First Posted: June 2, 2017
• Study Start: November 29, 2016
• Primary Completion: April 15, 2017
• Study Completion: April 15, 2017
• Last Updated: July 2, 2025

Record last verified: 2018-07

Locations

US (1)