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).
Parallel
GI-102 in combination with GIB-7
Combination productGI-102: recombinant protein drug, intravenous (IV) infusion, once every 4 weeks (Q4W); GIB-7: synbiotic formula, oral administration, once daily (QD)
Placebo
Combination productPlacebo for GI-102 in combination with GIB-7
Change in Baseline values in immune response (NK cells) before and after GI-102 and GIB-7 combination treatment
Maximum change from Baseline values in immune function, primarily in natural killer (NK) cells assessed by flow cytometry in blood samples.
Change in Baseline values in immune response (CD8+ T cells) before and after GI-102 and GIB-7 combination treatment
Maximum change from Baseline values in immune function, primarily in CD8⁺ T cells assessed by flow cytometry in blood samples.
Frequency of Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) of the combination of GI-102 and GIB-7 by severity
Frequency of Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) by severity.
Number of participants with various adverse events and abnormal lab data
Number of participants with Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), abnormal Vital signs, abnormal Electrocardiograms (ECGs), abnormal Physical examination findings, abnormal Chest X-ray, or abnormal Laboratory tests results
Change in Baseline values in sleep quality before and after GI-102 and GIB-7 combination treatment
Change from Baseline values in sleep quality using ISI (Insomnia Severity Index) at Week 8 and Week 10
Change in Baseline values in quality of life before and after GI-102 and GIB-7 combination treatment
Change from Baseline values in quality of life using EQ-5D (EuroQol 5 Dimension) at Week 8 and Week 10
Change in Baseline values in muscle function (hand grip strength) before and after GI-102 and GIB-7 combination treatment
Change from Baseline values in muscle function using hand grip strength test at Week 8 and Week 10
Change in Baseline values in muscle function (6 minute walk test) before and after GI-102 and GIB-7 combination treatment
Change from Baseline values in muscle function using 6 minute walk test at Week 8 and Week 10
Change in Baseline values in the hospital visits by GI-102 and GIB-7 combination treatment
Number of hospital visits compared to placebo at Week 8 and Week 10 (falls, fractures, pneumonia or severe respiratory illness, and other major health events may also be collected) to be conducted in a subgroup analysis (≥ 50 years)
Change in Baseline values in gut microbiome by GI-102 and GIB-7 combination treatment
Change from Baseline values in gut microbiome at Week 8 and Week 10 as indicated by fecal microbiota changes using alpha-diversity values and taxonomic relative abundances.
Change in Baseline values in cognitive function by GI-102 and GIB-7 combination treatment
Change from Baseline values in cognitive function at Week 8 and Week 10 as assessed by MoCA (Montreal Cognitive Assessment)
Survival (cancer survivors only)
In this study investigators will monitor overall survival defined as time from the inclusion to death or end of follow up at Week 10 (whichever comes first).
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GI Innovation, Inc.
Lead sponsor
GILongevity
Collaborator
