A Study of ACE-2494 in Healthy Subjects

NCT03478319 | Completed Phase 1 DMC

• 1 other identifier: A2494-01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Keywords

ACE-2494

Outcome Measures

Primary Outcomes (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

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

Secondary Outcomes (13)

• Determination of ACE-2494 serum Cmax

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

• Determination of ACE-2494 serum Tmax

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

• Determination of ACE-2494 serum T1/2

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

• Determination of ACE-2494 AUC

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

• Quantitation of serum GDF8 following ACE-2494 treatment

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

Study Arms (6)

Cohort 1

EXPERIMENTAL

ACE-2494 or placebo 0.06 mg/kg SC Day 1

Drug: ACE-2494 or placebo

Cohort 2

EXPERIMENTAL

ACE-2494 or placebo 0.2 mg/kg SC Day 1

Drug: ACE-2494 or placebo

Cohort 3

EXPERIMENTAL

ACE-2494 or placebo 0.6 mg/kg SC Day 1

Drug: ACE-2494 or placebo

Cohort 4

EXPERIMENTAL

ACE-2494 or placebo 1.0 mg/kg SC Day 1

Drug: ACE-2494 or placebo

Cohort 5

EXPERIMENTAL

ACE-2494 or placebo 2.0 mg/kg SC Day 1

Drug: ACE-2494 or placebo

Cohort 6

EXPERIMENTAL

ACE-2494 or placebo TBD (not to exceed 3.0 mg/kg SC) Day 1

Drug: ACE-2494 or placebo

Interventions

ACE-2494 or placebo DRUG

Recombination fusion protein

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.)

Sponsors & Collaborators

• Acceleron Pharma, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ USA: lead

Study Sites (1)

Syneos Health

Québec, G1P0A2, Canada

Location

Study Design

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

Study Record Dates

• First Submitted: March 7, 2018
• First Posted: March 27, 2018
• Study Start: February 15, 2018
• Primary Completion: June 13, 2019
• Study Completion: June 17, 2019
• Last Updated: July 18, 2019

Record last verified: 2019-07

Locations

CA (1)