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

Cancer Survivors Elderly Healthy Participant

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

Inclusion Criteria10

Must be aged between ≥18 and ≤80 years old at the time of informed consent.
At the discretion of the Investigator, must be in a state of general health that is not severely compromised (ie, no life-threatening illness or disability).
Participants with a history of cancer may be included only if they meet one of the following:
Participants have been disease-free for ≥2 years; OR
For those diagnosed within 2 years:
The cancer was treated with curative intent (eg, surgery, anti-cancer agents including chemotherapy)
Participants have been in remission for ≥12 months
Participants are not on any active cancer treatment except maintenance therapies (eg, endocrine therapy or bisphosphonates)
Participants must have received systemic anti-cancer therapies without immunotherapy for their cancers
Women of childbearing potential (WOCBP; see definition in Section 5.3) must agree to use a highly effective method of contraception from 14 days prior to Visit 2 until 180 days after the last dose of study medication (GI-102 or GIB-7). Fertile men must agree to use an acceptable method of contraception from 14 days prior to Visit 2 until 90 days after the last dose of study medication (GI-102 or GIB-7).

Exclusion Criteria5

Severe and poorly managed chronic diseases, such as advanced cardiovascular disease, kidney failure requiring transplant or dialysis, uncontrolled diabetes, detectable malignancy (≤ 2 years), severe chronic obstructive pulmonary disease (COPD), or untreatable, terminal cancer as judged by the Investigator or history of life threatening infection (eg, meningitis).
Dependent on walkers or wheelchairs; severe difficulty or inability to perform activities of daily living independently or inability to perform study measures required to test muscle function (an amputee is eligible if participants can walk without walkers or wheelchair) as judged by the Investigator.
Major surgery within the past 6 months or scheduled during the study period, including severe orthopedic diseases requiring joint replacement surgery.
History of substance abuse or dependency or history of recreational IV drug use over the last 5 years (by self-declaration).
Female participants who are pregnant, planning to become pregnant, or breastfeeding during the study period. Participants undergoing perimenopause or the menopause transition are eligible.