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
NCT07363057 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2026-01-26
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.
Conditions
- Cancer Survivors
- Healthy Participant
- Elderly
Interventions
- COMBINATION_PRODUCT
-
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)
- COMBINATION_PRODUCT
-
Placebo
Placebo for GI-102 in combination with GIB-7
Sponsors & Collaborators
-
GILongevity
collaborator INDUSTRY -
GI Innovation, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-01-31
- Primary Completion
- 2026-05-31
- Completion
- 2026-10-01
Countries
- Australia
Study Locations
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