Actively Recruiting
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
Led by GI Innovation, Inc. · Updated on 2026-01-26
15
Participants Needed
2
Research Sites
39 weeks
Total Duration
On this page
Sponsors
G
GI Innovation, Inc.
Lead Sponsor
G
GILongevity
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 80 years at informed consent
- In general health not severely compromised (no life-threatening illness or disability) as judged by the Investigator
- Cancer survivors must be disease-free for at least 2 years; or if diagnosed within 2 years, must have been treated with curative intent, in remission for at least 12 months, not on active cancer treatment except maintenance therapies, and have received systemic anti-cancer therapies without immunotherapy
- Women of childbearing potential must agree to use highly effective contraception from 14 days before Visit 2 until 180 days after last dose
- Fertile men must agree to use acceptable contraception from 14 days before Visit 2 until 90 days after last dose
You will not qualify if you...
- Severe and poorly managed chronic diseases such as advanced cardiovascular disease, kidney failure needing transplant or dialysis, uncontrolled diabetes, detectable malignancy within 2 years, severe COPD, untreatable terminal cancer, or history of life-threatening infection
- Dependent on walkers or wheelchairs or unable to perform daily activities independently, or unable to perform study muscle function tests
- Major surgery within the past 6 months or planned during the study
- History of substance abuse, dependency, or recreational IV drug use in the last 5 years
- Pregnant, planning pregnancy, or breastfeeding during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Novatrials
Charlestown, New South Wales, Australia, 2290
Actively Recruiting
2
Southern Oncology Clinical Research Unit
Adelaide, South Australia, Australia, 5042
Actively Recruiting
Research Team
W
Wayne Lee, Ph.D., MBA
CONTACT
K
Karen Hwang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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