Actively Recruiting
Phase 2a, Proof-Of-Concept, 8-Week, Randomized, Single-Blinded Trial of GI-102 Combined With GIB-7 to Evaluate Effects on Aging Biomarkers in Healthy Adults and Cancer Survivors
Led by GI Innovation, Inc. · Updated on 2026-01-26
15
Participants Needed
2
Research Sites
21 weeks
Total Duration
On this page
Sponsors
G
GI Innovation, Inc.
Lead Sponsor
G
GILongevity
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new combination treatment using GI-102 and GIB-7 to target key aging-related issues such as immune system aging, metabolic problems, and gut-brain-muscle interactions. This Phase 2a study focuses on healthy adults and cancer survivors to explore whether this dual approach can support healthier aging by addressing inflammation and bodily system balance. GI-102 is an intravenous protein drug given once every four weeks, designed to reactivate the immune system and reduce inflammation associated with aging. GIB-7 is an oral synbiotic containing probiotic strains that support gut health, circadian rhythms, and muscle and cognitive function. Participants receive either the combination of GI-102 and GIB-7 or a placebo over an 8-week period in a randomized, single-blinded setup. Participants will undergo assessments of immune response, muscle function, sleep quality, and quality of life from the start through 10 weeks. Researchers will monitor safety by tracking adverse events and laboratory data. This study lasts about 10 weeks, including treatment and follow-up visits, to evaluate changes in immune cells and physical performance measures.
CONDITIONS
Brief 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 the time of informed consent
- Generally in good health without severely compromised conditions
- Cancer survivors must be disease-free for at least 2 years OR
- If diagnosed within 2 years, cancer treated with curative intent and in remission for at least 12 months
- Not currently on active cancer treatments except maintenance therapies
- Women of childbearing potential must use effective contraception from 14 days before treatment until 180 days after last dose
- Fertile men must use acceptable contraception from 14 days before treatment 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 requiring transplant or dialysis, uncontrolled diabetes, severe COPD, or untreatable terminal cancer
- Dependent on walkers or wheelchairs or unable to perform daily activities independently or required muscle function tests
- Major surgery within past 6 months or planned during the study period
- History of substance abuse or recreational IV drug use within 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive the combination of GI-102 by intravenous infusion once every 4 weeks and GIB-7 orally once daily, or placebo.
Visits at baseline, Week 4, and Week 8
Duration - 2 weeks
Participants are monitored for safety and outcomes after completing treatment.
1 visit at Week 10
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
K
Karen Hwang
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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