What is GI-102 studying for aging and health in this trial?

GI-102, combined with GIB-7, is being studied to understand its effects on key aging processes such as immune system aging, inflammation, and gut health. Researchers aim to see how this combination influences biological markers related to aging in healthy adults and cancer survivors. This trial is sponsored by GI Innovation, Inc. and focuses on improving healthspan through a novel treatment approach.

Who may be eligible for this aging study clinical trial?

Adults aged 18 to 80 years who are generally in good health may be eligible. Cancer survivors can participate if they have been disease-free for at least 2 years or are in remission after curative treatment. Both men and women can join, but women of childbearing potential must use effective contraception. Please review eligibility criteria for more details.

Is there any cost to participate in this aging clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses and other costs may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or accommodation needs.

Actively Recruiting

Phase 2

Age: 18Years - 80Years

All Genders

Healthy Volunteers

ID07363057

Phase 2a Study of GI-102 and GIB-7 Combination to Improve Aging Biomarkers in Healthy Adults and Cancer Survivors

Led by GI Innovation, Inc. · Updated on 2026-01-26

Participants Needed

Research Sites

21 weeks

Total Duration

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

Age: 18Years - 80Years

All Genders

Healthy Volunteers

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

Research Team

Wayne Lee, Ph.D., MBA

Karen Hwang

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Phase 2a Study of GI-102 and GIB-7 Combination to Improve Aging Biomarkers in Healthy Adults and Cancer Survivors

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria