萝莉社

This study will involve about 60 people and will be conducted to investigate how well Isomyosamine helps people with sarcopenia (age-related loss of muscle) or frailty heal after breaking a bone. The study will also help the Sponsor learn how well the study drug is tolerated in subjects with chronic inflammation associated with sarcopenia/frailty. This study will help the Sponsor to determine if the study drug will help improve healing of a broken bone in people with frailty or sarcopenia as well as reduce inflammation.

To participate, you will be monitored carefully throughout the study. At the first sign of an unacceptable side effect, your study doctor will decide how to best care for you, including removing you from the study if your study doctor feels this is in your best interest.

Potential post-surgical study participants must be willing to participate for 3 months of post-operative follow-up with regular visits, blood draws and frailty/sarcopenia assessments. Individuals who meet all of the following criteria at post-operatively are eligible for enrollment in the study:

1. Age 60 to 85 years of age
   
2. Non-complex, non-comminuted fracture of the femoral head, femoral neck, or acetabulum due to an accidental (non-neurologic or cardiovascular) fall
   
3. Concomitant medication limited to treatment for chronic conditions;

   4.The ability to give informed consent and comply with study procedures;
   

   5.Body weight ≥35 kg;
   6.Adequate dietary intake;
   7.Potential subjects’ intention to avoid reproductive activity will be confirmed. 

   And one or more of the following criteria:
   

4. Previous history frailty or sarcopenia diagnosis using standardized tests;
   
5. Positive assessment for frailty or sarcopenia using standardized tests or as per clinician’s judgement;
   
6. Previous positive assessment for elevated biomarkers of inflammation (serum IL-6 level> LOQ, TNFR1 level > LOQ, and/or TNF-? level > LOQ)

   Subjects who meet any of the following criteria are not eligible for enrollment:
   

7. Receiving immunotherapy for cancer or solid organ transplantation
   
8. Complex or comminuted fracture or fracture of multiple long bones
   
9. Regular treatment for chronic disease including chronic renal failure, chronic heart failure (CHF) cerebrovascular disease including stroke, rheumatoid arthritis, or polymyalgia rheumatica
   
10. Newly (< 2 weeks) diagnosed COVID-19
    
11. Inability or unwillingness to give written informed consent.
    
12. History of upper/lower respiratory tract infection, requiring systemic steroids, antibiotics, and or emergency room (ER) visit or urgent care within 6 weeks of screening visit.
    
13. History of adverse reaction or allergy to TNF inhibitor
    
14. History of neurological, hepatic, renal, diabetic mellitus, thyroid disorder, psychiatric, addiction or other medical conditions that may interfere with the interpretation of data or the patient’s participation in the study or may increase safety concerns per investigator discretion.
    
15. Currently under treatment by an anti-TNFα drug, such as adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, and biosimilars.
    
16. Currently under treatment by an anti-diabetic medication, including glucagon-like peptide-1 (GLP-1) drugs such as semaglutide, or any of metformin, jenuvia, or insulin
    
17. Unwillingness or inability to comply with study procedures, including smoking cessation.