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
Condition(s) studied
Investigational drug(s) / intervention(s)
GI-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)
Placebo: Placebo for GI-102 in combination with GIB-7
Study 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
Primary outcome measure(s)
- Change in Baseline values in immune response (NK cells) before and after GI-102 and GIB-7 combination treatment — From Day 1 until Week 10 visit
Maximum change from Baseline values in immune function, primarily in natural killer (NK) cells assessed by flow cytometry in blood samples. - Change in Baseline values in immune response (CD8+ T cells) before and after GI-102 and GIB-7 combination treatment — From Day 1 until Week 10 visit
Maximum change from Baseline values in immune function, primarily in CD8⁺ T cells assessed by flow cytometry in blood samples. - Frequency of Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) of the combination of GI-102 and GIB-7 by severity — From Day 1 until Week 10 visit
Frequency of Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) by severity. - Number of participants with various adverse events and abnormal lab data — From Day 1 until Week 10 visit
Number of participants with Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), abnormal Vital signs, abnormal Electrocardiograms (ECGs), abnormal Physical examination findings, abnormal Chest X-ray, or abnormal Laboratory tests results
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Novatrials | Charlestown | New South Wales | Recruiting |
| Southern Oncology Clinical Research Unit | Adelaide | South Australia | Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07363057 on ClinicalTrials.gov ↗ ← All trials in Australia