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
Trial Parameters
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Brief 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 Criteria
Key Inclusion Criteria: 1. Must be aged between ≥18 and ≤80 years old at the time of informed consent. 2. 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). 3. Participants with a history of cancer may be included only if they meet one of the following: 1. Participants have been disease-free for ≥2 years; OR 2. 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 4. 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