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Healthy VolunteersPhase 1NCT03478319

A Study of ACE-2494 in Healthy Subjects

A Phase 1 study of Healthy Volunteers, run by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the study is to assess safety, tolerance, pharmacokinetic, and pharmacodynamics of single doses of ACE-2494 in healthy postmenopausal women. Read more about this study

Who is it for?
Ages 45 to 75 years, women onlyHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
1 siteCanada
Study dates
15 Feb 2018to 17 Jun 2019
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 45 to 75 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Postmenopausal women, with menopause defined by follicle stimulating hormone (FSH) level > 40 IU/L and either 12 months of spontaneous amenorrhea or at least 6 months post-surgical bilateral oophorectomy and/or hysterectomy
  • Age 45-75 years
  • Body mass index (BMI) 18.5-32.0 kg/m2
  • Clinical laboratory values that meet the following criteria prior to dosing on Day 1:
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2 x upper limit of normal (ULN)
  • Serum creatinine ≤ 1.5 x ULN
  • Ability to adhere to the study visit schedule/procedures, and to understand and comply with protocol requirements
  • Signed written informed consent

Who cannot join

  • Smokers (use of tobacco products within 3 months prior to screening)
  • History of hepatitis B (HBsAg and HB core Ab), human immunodeficiency virus (HIV) antibody or active hepatitis C
  • Positive drug or alcohol screen test at screening or on Day 1
  • History of drug or alcohol abuse (as defined by the investigator) or required treatment for drug or alcohol use within 2 years of Day 1
  • Donated or lost ≥ 500 mL of whole blood within 2 months prior to Day 1
  • History of opportunistic infection (e.g., invasive candidiasis or pneumocystis pneumonia) within 6 months prior to screening; serious local infection (e.g., cellulitis, abscess) or systemic infection (e.g., septicemia) within 3 months prior to screening
Show all 13Show fewer
  • History of severe allergic or anaphylactic reaction or hypersensitivity to recombinant proteins or any other drugs
  • Systemic glucocorticoid therapy, statin medication, growth hormone, androgen, insulin, oral hormone replacement therapy or any other therapy (including investigational) with known or intended effects on muscle within 3 months prior to Day 1
  • Anti platelet, anti-coagulant, or any other therapy (including investigational) with known or intended effects on bleeding risk within 1 week prior to Day 1 (Daily low-dose aspirin is allowed)
  • Treatment with another investigational drug, device, or approved therapy for investigational use within 30 days prior to Day 1; administration of a biological product in the context of a clinical research study within 90 days prior to Day 1
  • Participation in another clinical trial involving intervention with or without an investigational drug or device at any time during the study period
  • Unwilling or unable to maintain physical activity at baseline level for the duration of the study
  • For Cohorts 4-6 only, any condition that would prevent MRI scanning or compromise the ability to obtain a clear and interpretable scan of the thigh (e.g., pacemaker, knee/hip replacement, metallic implant, extreme claustrophobia, etc.)

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Syneos Health

    Québec, G1P0A2

Other trials in Canada

About this study

Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of ACE-2494 in Healthy Postmenopausal Women

The purpose of the study is to assess safety, tolerance, pharmacokinetic, and pharmacodynamics of single doses of ACE-2494 in healthy postmenopausal women.

Read the detailed description

Subjects will be evaluated for study inclusion/exclusion criteria during the screening period (within 4 weeks prior to Day -1) and eligible subjects who have signed the informed consent form (ICF) will be enrolled and treated with study drug (ACE-2494 or placebo) on Day 1. Subjects will be randomized (3:1, ACE-2494: placebo) to receive one dose of either ACE-2494 or placebo, respectively, on Day 1.

The primary objective of the study is to evaluate the safety and tolerability of single ascending doses of ACE-2494 in healthy postmenopausal women. The secondary objectives are to characterize the pharmacokinetic (PK) profile and pharmacodynamic (PD) effects, including serum biomarkers, fat, lean, and bone mass (DXA), muscle volume and intramuscular fat fraction (MRI).

Being tested
ACE-2494 or placebo
Keywords
ACE-2494

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACE-2494 or placeboDrug

    Recombination fusion protein

Study groups in NCT03478319
Study groupRoleWhat they receive
Cohort 1ExperimentalACE-2494 or placebo 0.06 mg/kg SC Day 1
Receives: Drug: ACE-2494 or placebo
Cohort 2ExperimentalACE-2494 or placebo 0.2 mg/kg SC Day 1
Receives: Drug: ACE-2494 or placebo
Cohort 3ExperimentalACE-2494 or placebo 0.6 mg/kg SC Day 1
Receives: Drug: ACE-2494 or placebo
Cohort 4ExperimentalACE-2494 or placebo 1.0 mg/kg SC Day 1
Receives: Drug: ACE-2494 or placebo
Cohort 5ExperimentalACE-2494 or placebo 2.0 mg/kg SC Day 1
Receives: Drug: ACE-2494 or placebo
Cohort 6ExperimentalACE-2494 or placebo TBD (not to exceed 3.0 mg/kg SC) Day 1
Receives: Drug: ACE-2494 or placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with ACE-2494 treatment-related adverse events as assessed by CTCAE v5.0

    Adverse events (including both clinical observations and laboratory measurements), deemed related to ACE-2494 treat, will be recorded for each study subject

    Measured: From initiation of treatment (Study Day 1) to end of follow-up period (Study Day 85)

Secondary outcomes (13)

  1. Determination of ACE-2494 serum Cmax

    Determination of maximum serum concentration of ACE-2494 following subcutaneous administration

    Measured: From initiation of treatment, Study Day (SD)1 to end of follow-up period (SD85)

  2. Determination of ACE-2494 serum Tmax

    Determination of time to maximum serum concentration of ACE-2494 following subcutaneous administration

    Measured: From initiation of treatment, Study Day (SD)1 to end of follow-up period (SD85)

  3. Determination of ACE-2494 serum T1/2

    Determination of serum half-life of ACE-2494 following subcutaneous administration

    Measured: From initiation of treatment, Study Day (SD)1 to end of follow-up period (SD85)

  4. Determination of ACE-2494 AUC

    Determination of the area under the serum concentration curve of ACE-2494 following subcutaneous administration

    Measured: From initiation of treatment, Study Day (SD)1 to end of follow-up period (SD85)

  5. Quantitation of serum GDF8 following ACE-2494 treatment

    Quantitation of serum levels of growth differentiation factor (GDF)8 following treatment with ACE-2492

    Measured: From initiation of treatment, Study Day (SD)1 to end of follow-up period (SD85)

  6. Quantitation of serum BSAP following ACE-2494 treatment

    Quantitation of serum levels of bone-specific alkaline phosphatase (BSAP) following treatment with ACE-2494

    Measured: From initiation of treatment, Study Day (SD)1 to end of follow-up period (SD85)

  7. Quantitation of serum CTX following ACE-2494 treatment

    Quantitation of serum levels of carboxy-terminal collagen crosslinks (CTX) following treatment with ACE-2494

    Measured: From initiation of treatment, Study Day (SD)1 to end of follow-up period (SD85)

  8. Quantitation of serum FSH following ACE-2494 treatment

    Quantitation of serum levels of follicle stimulating hormone (FSH) following treatment with ACE-2494

    Measured: From initiation of treatment, Study Day (SD)1 to end of follow-up period (SD85)

  9. Determination of body composition following ACE-2494 treatment by DXA

    Regional and whole-body quantitation of fat mass by dual energy X-ray absorptiometry (DXA) following treatment with ACE-2494

    Measured: From initiation of treatment, Study Day (SD)1 to end of follow-up period (SD85)

  10. Determination of body composition following ACE-2494 treatment by DXA

    Regional and whole-body quantitation of lean mass by dual energy X-ray absorptiometry (DXA) following treatment with ACE-2494

    Measured: From initiation of treatment, Study Day (SD)1 to end of follow-up period (SD85)

  11. Determination of body composition following ACE-2494 treatment by DXA

    Regional and whole-body quantitation of bone mass by dual energy X-ray absorptiometry (DXA) following treatment with ACE-2494

    Measured: From initiation of treatment, Study Day (SD)1 to end of follow-up period (SD85)

  12. Determination of thigh muscle volume and intramuscular fat following ACE-2494 treatment by MRI for patients in Cohorts 4-6 only

    Determination of total muscle volume in the thigh by magnetic resonance imaging (MRI)

    Measured: From initiation of treatment, Study Day (SD)1 to end of follow-up period (SD85)

  13. Determination of thigh muscle volume and intramuscular fat following ACE-2494 treatment by MRI for patients in Cohorts 4-6 only

    Determination of intramuscular fat in the thigh by magnetic resonance imaging (MRI)

    Measured: From initiation of treatment, Study Day (SD)1 to end of follow-up period (SD85)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2018
  2. Study start15 Feb 2018
  3. Primary completion13 Jun 2019
  4. Study completion17 Jun 2019

Resources

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03478319
Sponsor's protocol ID
A2494-01
Status last verified
Jul 2019
First submitted
7 Mar 2018
Last updated
18 Jul 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study of Healthy Volunteers, run by Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA at 1 site in Canada.

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 8 inclusion and 13 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 18 Jul 2019. 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 Canada. 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. 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 ACE-2494 treatment-related adverse events as assessed by CTCAE v5.0 (time frame: From initiation of treatment (Study Day 1) to end of follow-up period (Study Day 85)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03478319.

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 18 Jul 2019.

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