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

Viatris Innovation GmbH

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: AC-076 for s.c. administration; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03173625

AC-076-102

Details and patient eligibility

About

The main objective of the study is to investigate the safety and tolerability of single ascending doses of AC-076 administered as subcutaneous injection

Enrollment: 72 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 2 patient groups, including a placebo group

AC-076 sc administration - single ascending dose

Experimental group

Description:

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)

Treatment:

Drug: AC-076 for s.c. administration

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo