A Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ALG-801 in Healthy Postmenopausal Wome

Phase 1

Completed

• Conditions: Bone loss; Muscle wasting; Musculoskeletal - Normal musculoskeletal and cartilage development and function; Musculoskeletal - Osteoporosis

• Registration Number: ACTRN12623000204640
• Lead Sponsor: AliveGen USA, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-02-27
• Study Completion: 2023-12-28
• Last Update Posted: 8 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 32

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified