Healthy SubjectsPhase 1NCT03173625
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
A Phase 1 study testing AC-076 for s.c. administration in people with Healthy Subjects, run by Viatris Innovation GmbH at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- AC-076 for s.c. administration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2016to 15 Apr 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official 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
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
- Being tested
- AC-076 for s.c. administration, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AC-076 for s.c. administrationDrug
Lyophilized AC-076A to be reconstituted with 1 mL of water for injection
PlaceboDrug
Sterile 0.9% w/v sodium chloride solution
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs)
Treatment-emergent AEs and treatment-emergent serious AEs
Measured: 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
Measured: From study treatment administration up to day 3
Changes from baseline in supine blood pressure
Supine blood pressure (mmHg)
Measured: From study treatment administration up to day 3
Changes from baseline in pulse rate
Pulse rate (bpm)
Measured: From study treatment administration up to day 3
Secondary outcomes (6)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: From baseline up to day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2017
- Study start29 Nov 2016
- Primary completion15 Apr 2017
- Study completion15 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viatris Innovation GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Viatris Innovation GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03173625
- Sponsor's protocol ID
- AC-076-102
- Status last verified
- Jul 2018
- First submitted
- 23 May 2017
- Last updated
- 2 Jul 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03173625
- Acronym / sponsor ID
- AC-076-102
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Viatris Innovation GmbHIndustry (pharma, biotech, devices)
- Study start
- 29 Nov 2016 (actual)
- Primary completion
- 15 Apr 2017 (actual)
- Study completion
- 15 Apr 2017 (actual)
- First posted
- 2 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AC-076 sc administration - single ascending dose | Experimental | Drug: AC-076 for s.c. administrationOn 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) |
| Placebo | Placebo comparator | Drug: PlaceboFor each AC-076 dose level tested, 2 healthy male subjects will receive matching placebo in the same condition |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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%
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AC-076 for s.c. administrationLyophilized AC-076A to be reconstituted with 1 mL of water for injection | Drug | AC-076 sc administration - single ascending dose |
| PlaceboSterile 0.9% w/v sodium chloride solution | Drug | Placebo |
Primary outcome
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
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
Changes from baseline in supine blood pressure
Time frame: From study treatment administration up to day 3
Supine blood pressure (mmHg)
Changes from baseline in pulse rate
Time frame: From study treatment administration up to day 3
Pulse rate (bpm)
6 secondary outcomes
Measurement of inhibition of platelet aggregation (IPA) using anticoagulant assays
Time frame: From baseline up to day 3
Maximum plasma concentration (Cmax) of AC-076
Time frame: From baseline up to day 3
time to reach Cmax (tmax)
Time frame: From baseline up to day 3
terminal half-life (t1/2)
Time frame: From baseline up to day 3
Area under the plasma concentration-time curves during a dosing interval [AUC(0-t)] of
Time frame: From baseline up to day 3
Area under the plasma concentration-time curves from time 0 to inf [AUC(0-inf)]
Time frame: From baseline up to day 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Viatris Innovation GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AC-076 for s.c. administration in people with Healthy Subjects, run by Viatris Innovation GmbH at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events (AEs) (time frame: From study treatment administration up to day 3). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.