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

NCT ID: NCT03173625

Last Updated: 2025-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-29
• Study Completion Date: 2017-04-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

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)

Group Type: EXPERIMENTAL

AC-076 for s.c. administration

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Sterile 0.9% w/v sodium chloride solution

Interventions

AC-076 for s.c. administration

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

Intervention Type: DRUG

Placebo

Sterile 0.9% w/v sodium chloride solution

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Viatris Innovation GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Viatris Innovation GmbH

Locations

Biotrial Inc.

Newark, New Jersey, United States

Countries

United States

Other Identifiers

AC-076-102

Identifier Type: -

Identifier Source: org_study_id