RecruitingPhase 2NCT07363057

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

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


Sponsor

GI Innovation, Inc.

Enrollment

15 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a combination of two supplements — GI-102 and GIB-7 — can positively affect biological markers associated with aging in healthy adults and cancer survivors. The goal is to understand if these supplements may support healthier aging at a cellular level. **You may be eligible if...** - You are between 18 and 80 years old - You are in generally good health without a life-threatening illness - If you have had cancer, you have been disease-free for at least 2 years, OR you have been in remission for at least 12 months and are not currently on active cancer treatment (maintenance therapy like hormone therapy is okay) **You may NOT be eligible if...** - You are currently undergoing active cancer treatment (other than maintenance therapy) - You have a serious ongoing illness or disability - You do not meet the study's health thresholds as assessed by the study team Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTGI-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_PRODUCTPlacebo

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

View Full Details on ClinicalTrials.gov

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NCT07363057


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