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Trying to find the AA sequence for ACE 083.. any suggestions?

JBEXT81

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Registered
Joined
Jan 26, 2014
Messages
85
def want to try....

found this on google

Quote
+++
ACE-083

for Muscle Loss


ACE-083 is an investigational protein therapeutic that has been designed for local administration to increase muscle mass and strength in specific muscles and muscle groups. Acceleron is developing ACE-083 for diseases in which improved muscle strength may provide a clinical benefit, such as inclusion body myositis and certain forms of muscular dystrophy.
+++
Unquote

local administration so im guessing this will be in the muscles trained that day ?!?!

Acceleron Pharma » ACE-083
 

jaymac

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Jan 6, 2011
Messages
140
I think i saw that log.

He did 1mg per bicep (1/2mg per head)

He gained half an inch in a week.

Right?

I believe so. The measurement was hard to see. I pm'd him and he said the gains are still there!
 

jaymac

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Jan 6, 2011
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Well Im doing more or less a controlled test. I'm not working out. ( lifting) as much as I would like to , it wouldn't be a very good test if I have been. Didn't really mentioned. That part my apologies

Any updates? How's research going?
 

jaymac

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Phase 1 Study of ACE-083 in Healthy Subjects
This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Acceleron Pharma, Inc.
Sponsor:
Acceleron Pharma, Inc.
Information provided by (Responsible Party):
Acceleron Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT02257489
First received: October 2, 2014
Last updated: October 14, 2014
Last verified: October 2014
History of Changes
Full Text View Tabular ViewNo Study Results PostedDisclaimerHow to Read a Study Record
Purpose
This study will evaluate the the safety and tolerability of single and multiple doses of ACE-083 as a local injection into the thigh muscle of healthy subjects. The study will also determine the amount of ACE-083 that reaches the systemic circulation following local administration. Additionally, the study will assess whether local administration into the thigh muscle results in an increase in the size and/or strength of the injected muscle.


Condition Intervention Phase
Focus of the Study is Primarily Safety in Healthy Subjects
Drug: ACE-083
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: A Phase 1, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of Local Muscle Injections of ACE-083 in Healthy Postmenopausal Women

Further study details as provided by Acceleron Pharma, Inc.:

Primary Outcome Measures:
ACE-083 safety and tolerability [ Time Frame: From initiation of treatment (Study Day 1) to end of follow up period (up to Study Day 106) ] [ Designated as safety issue: Yes ]
safety/tolerability assessment, following intramuscular administration, includes adverse events, injection site reactions, laboratory measurements, vital signs, etc.


Secondary Outcome Measures:
ACE-083 pharmacokinetics [ Time Frame: From initiation of treatment (Study Day 1) to Study Day 92 ] [ Designated as safety issue: No ]
Assessment of systemic absorption and exposure following local injection of ACE-083 into the thigh muscle

ACE-083 pharmacodynamics [ Time Frame: From initiation of treatment (Study Day 1) to end of follow up period (up to Study Day 106) ] [ Designated as safety issue: No ]
Pharmacodynamic assessments include measurements of thigh volume and composition (by MRI) and muscle strength testing


Estimated Enrollment: 40
Study Start Date: October 2014
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 50 mg single dose
8 subjects in total; 6 subjects to received ACE-083 (50 mg) and 2 subjects to receive placebo, single injection, intramuscularly
Drug: ACE-083
ACE-083, recombinant fusion protein
Experimental: 100 mg single dose
8 subjects in total; 6 subjects to received ACE-083 (100 mg) and 2 subjects to receive placebo, single injection, intramuscularly
Drug: ACE-083
ACE-083, recombinant fusion protein
Experimental: 200 mg single dose
8 subjects in total; 6 subjects to received ACE-083 (2000 mg) and 2 subjects to receive placebo, single injection, intramuscularly
Drug: ACE-083
ACE-083, recombinant fusion protein
Experimental: 100 mg multiple dose
8 subjects in total; 6 subjects to received ACE-083 (100 mg) and 2 subjects to receive placebo, two injections 3 weeks apart, intramuscularly
Drug: ACE-083
ACE-083, recombinant fusion protein
Experimental: 200 mg multiple dose
8 subjects in total; 6 subjects to received ACE-083 (200 mg) and 2 subjects to receive placebo, two injections 3 weeks apart, intramuscularly
Drug: ACE-083
ACE-083, recombinant fusion protein

Detailed Description:
ACE-083 is a molecule that has been shown to increase skeletal muscle mass in animals and, therefore, has potential utility in certain diseases that affect skeletal muscle. This initial study in healthy human subjects will help determine the properties of ACE-083 (safety, tolerability, drug absorption and biologic activity), following local administration into skeletal muscle, in advance of clinical trials in patients.

The study will consist of up to 5 planned groups of 8 subjects each. Subjects in each cohort will be randomized to receive either ACE-083 or placebo. ACE-083 (or placebo) will be administered locally into the right quadriceps (thigh) muscle. Subjects will receive a total of either one dose (on Day 1) or two doses (on Day 1 and Day 22). Each dose administered could include up to 4 injections of study drug into pre-defined locations in the muscle.

A Safety Review Team (SRT) will review blinded, preliminary data from each treatment group to make recommendations regarding escalation to the next treatment grop. Subjects will be assessed for safety throughout the treatment and follow-up periods. Follow-up visits will occur over 12 weeks following the last dose of study drug.

Eligibility

Ages Eligible for Study: 45 Years to 75 Years
Genders Eligible for Study: Female
Accepts Healthy Volunteers: Yes
Criteria
Inclusion Criteria:

Postmenopausal women, 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
BMI 18.5-32 kg/m2
Clinical laboratory values that meet the following criteria prior to dosing on Study Day 1: (i) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2 x upper limit of normal (ULN), (ii) Calculated creatinine clearance ≥ 60 mL/min, (iii) Platelet count ≥ 100 x109/L
Able to adhere to the study visit schedule, understand and comply with protocol requirements
Understand and sign written informed consent
Exclusion Criteria:

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
Donation or loss ≥ 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
History of active malignancy, with the exception of fully excised or treated basal cell carcinoma, cervical carcinoma in-situ, or ≤ 2 squamous cell carcinomas of the skin
History of clinically significant (as determined by the Investigator) cardiac, endocrine, hematologic, hepatic, immune, metabolic, urologic, pulmonary, neurologic, neuromuscular, dermatologic, psychiatric, renal, and/or other disease
Treatment with systemic glucocorticoid therapy, statin medication, 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
Treatment with 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
Treatment with another investigational drug, or approved therapy for investigational use within 4 weeks prior to Day 1, or if the half-life of the previous product is known, within 5 times the half-life prior to Day 1, whichever is longer
Treatment within 3 months prior to Day 1 with any potent cytochrome P450 (CYP) 3A4/5 inhibitors (e.g., verapamil, ketoconazole, micronazole, itraconazole, erythromycin, telithromycin, clarithromycin, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, atazanavir, amprenavir, fosamprenavir, delavirdine) or CYP3A4/5 inducers (carbamazepine, dexamethasone, felbamate, omeprazole, phenobarbital, phenytoin, amobarbital, nevirapine, primidone, rifabutin, rifampin, St. John's wort)
Subject is unwilling or unable to maintain physical activity at baseline level for the duration of the study
Subject has any condition that would prevent MRI scanning (e.g., pacemaker, knee/hip replacement, metallic implant, or extreme claustrophobia)
Subject is unsuitable for enrollment in the opinion of the Investigator or Sponsor for other unspecified reasons
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02257489

Contacts
Contact: Meredith Schiller 617-649-9298 [email protected]
Contact: Kenneth M Attie, MD 617-649-9350 [email protected]

Locations
United States, Nebraska
Acceleron Investigative Site Recruiting
Lincoln, Nebraska, United States, 68502
Sponsors and Collaborators
Acceleron Pharma, Inc.
Investigators
Study Director: Kenneth M Attie, MD Acceleron Pharma, Inc.
More Information

No publications provided

Responsible Party: Acceleron Pharma, Inc.
ClinicalTrials.gov Identifier: NCT02257489 History of Changes
Other Study ID Numbers: A083-01
Study First Received: October 2, 2014
Last Updated: October 14, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 28, 2014

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jaymac

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Jan 6, 2011
Messages
140
I'm not sure now what's the best way to run this? The mice studies did twice a week injections. The human studies are doing 2 injects only 3 weeks apart. They are also doing 50mg to 400mg. So with 6 to 8 mg I'm not sure if it would be best to stick with the way the other 2 people are doing it twice weekly or since I'm a human do 3-4 mg then 3 weeks later another 3-4mg or just 6 to 8 mg at once? Any ideas?
 

hood_rat

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Dec 21, 2012
Messages
79
mice have more myostatin then we do so maybe they need more frequent injections? bro science on my part but just throwing out ideas
 

crunchy

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Jan 17, 2014
Messages
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I stopped taking mine. Seemed to work, buy my knees began killing me.
 

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