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A Study to Evaluate the Effects of the Combination of GI-102 With GIB-7 on Biomarkers of Aging in Healthy Adults and Cancer Survivors
Sponsor: GI Innovation, Inc.
Summary
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.
Official title: Phase 2a, Proof-Of-Concept, Multi-National, 8-Week, Randomized, Single-Blinded, Placebo-Controlled Trial of GI-102 in Combination With GIB-7 to Evaluate Its Effects on Biomarkers of Aging in Healthy Adults and Cancer Survivors
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
15
Start Date
2026-01
Completion Date
2026-10-01
Last Updated
2026-01-26
Healthy Volunteers
Yes
Interventions
GI-102 in combination with GIB-7
GI-102: recombinant protein drug, intravenous (IV) infusion, once every 4 weeks (Q4W); GIB-7: synbiotic formula, oral administration, once daily (QD)
Placebo
Placebo for GI-102 in combination with GIB-7
Locations (2)
Novatrials
Charlestown, New South Wales, Australia
Southern Oncology Clinical Research Unit
Adelaide, South Australia, Australia