This Phase 2a clinical study (GIANTS-1) aims to evaluate a novel dual-combination strategy using GI-102 and GIB-7 to address key pathological features of aging, including immunosenescence (the aging of the immune system), metabolic dysfunction, and gut-brain-muscle axis dysregulation.
Must be aged between ≥18 and ≤80 years old at the time of informed consent.
At the discretion of the Investigator, must be in a state of general health that is not severely compromised (ie, no life-threatening illness or disability).
Participants have been disease-free for ≥2 years; OR
The cancer was treated with curative intent (eg, surgery, anti-cancer agents including chemotherapy)
Severe and poorly managed chronic diseases, such as advanced cardiovascular disease, kidney failure requiring transplant or dialysis, uncontrolled diabetes, detectable malignancy (≤ 2 years), severe chronic obstructive pulmonary disease (COPD), or untreatable, terminal cancer as judged by the Investigator or history of life threatening infection (eg, meningitis).
Dependent on walkers or wheelchairs; severe difficulty or inability to perform activities of daily living independently or inability to perform study measures required to test muscle function (an amputee is eligible if participants can walk without walkers or wheelchair) as judged by the Investigator.
Major surgery within the past 6 months or scheduled during the study period, including severe orthopedic diseases requiring joint replacement surgery.
History of substance abuse or dependency or history of recreational IV drug use over the last 5 years (by self-declaration).
GI Innovation, Inc.
Lead sponsor
GILongevity
Collaborator