None listed
Conditions
Brief summary
In postmenopausal women, the follicle stimulating hormone (FSH) is elevated. Elevated FSH has been shown to accelerate aging, as high FSH leads to decreased bone mass, reduced muscle mass and increased fat mass, as well as to increased risks of diabetes, metabolic syndrome, kidney dysfunction, heart disease and Alzheimer’s disease. ALG-801 has been designed to block certain proteins within the transforming growth factor-beta (TGF-ß) family, including activin A and activin B, which stimulate FSH release. By blocking these proteins that control the release of FSH hormone, the effects of elevated FSH on bone loss, muscle atrophy, fat accumulation and insulin resistance may be reduced. This clinical study is designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics of ALG-801 in healthy postmenopausal women who meet the eligibility requirements. This study is a multiple ascending (increasing) dose study where approximately 32 participants will be randomized to receive 4 doses of the study drug or placebo over a period of 4 weeks. The primary objective of this study is to establish safe dose levels of ALG-801 in healthy postmenopausal women following multiple dose administration, and secondarily to evaluate the influence of ALG-801 on biomarkers of bone turnover and muscle mass.
Interventions
4 subcutaneous doses of ALG-801 given weekly over a period of one month.
3 ascending dose levels at 1 mg/kg, 3 mg/kg and 4.5 mg/kg will be tested.
Sponsors
AliveGen USA, Inc.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
45 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
-Subject is postmenopausal -Body mass index (BMI) between 18.5 and 35 kg/m2 (inclusive) -Free from clinically significant unstable medical problems as determined by the Investigator, and if medicated, the medication does not interfere with the investigational product
Exclusion criteria
-Hospitalization within the 3 months prior to the first dose of study treatment -Has an established diagnosis of diabetes mellitus, as indicated by use of diabetes medication, Hb A1C greater than 6.4% or fasting glucose equal to 126 mg/dL (7.0 mmol/L) -Positive test for drugs of abuse (including recreational drugs) at screening and admission to the research unit -Receipt of an investigational study to evaluate pharmaceuticals or biologics within the past 1 month or 5 half-lives, whichever is longer -Prior treatment with any ActRIIA- or ActRIIB-related ligand trap, such as KER-12, KER-50, ACE-536 (Luspatercept), ACE-011 (Sotatercept) and ACE-031 -History of any malignant cancer during the past 5 years, except treated nonmelanotic skin cancer or carcinoma in situ of the uterine cervix -History of a major adverse cardiovascular event during the past 6 month -History of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, autoimmune diseases, dermatologic, neurologic, oncologic, psychiatric disease (except for mild depression and anxiety) -History of opportunistic infection within 6 months prior to screening or serious local infection or systemic infection within 3 months prior to screening -Major surgery within 12 weeks prior to Day 1, except for minor cosmetic or dental procedures. -Fever or symptomatic infection (viral or bacterial) within 7 days prior to Day 1 -Blood donation or significant blood loss (480mL or more) within 30 days prior to Day 1 -Hormone replacement therapy within 12 weeks prior to Day 1; infrequent use of estrogen vaginal creams (less than 3 times per week) is allowed -Anti-osteoporosis medications (e.g., bisphosphonates, denosumab, teriparatide, romosozumab, etc.) within 28 days of first dosing or within 5 times the elimination half-life of the medication prior to first dosing, whichever is longer -Systemic glucocorticoid therapy within 6 months prior to Day 1 -Protein supplements or nutritional supplements for muscle building or supplements which contain anabolic or ergogenic substances (e.g., creatine) within 28 days of first dosing -History of significant bleeding disorder or known disease involving platelet number and/or function
Outcome results
None listed