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RECRUITING
NCT07363057
PHASE2

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

Sponsor: GI Innovation, Inc.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2026-01

Completion Date

2026-10-01

Last Updated

2026-01-26

Healthy Volunteers

Yes

Interventions

COMBINATION_PRODUCT

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)

COMBINATION_PRODUCT

Placebo

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