Randomized, Double-Blind, Placebo-Controlled First-in-Human Trial of a First-in-Class AI-Designed Monoclonal Antibody (GB-0669) Against the Conserved SARS-CoV-2 Spike S2 Stem Helix
Background Antibodies against the SARS-CoV-2 spike receptor-binding domain provided effective COVID-19 treatment until resistant variants emerged. GB-0669 is a half-life-extended monoclonal antibody optimized using artificial intelligence. It targets the conserved spike S2 stem helix, a region subject to limited selective pressure from antibody responses induced by natural infection or vaccination. Methods Pre-clinical safety studies were conducted in cynomolgus monkeys. In the first-in-human trial, healthy adul…
AI-optimized monoclonal antibody GB-0669 was safe and well-tolerated in healthy adults with dose-proportional pharmacokinetics and a 54-day half-life and dose-dependent serum live virus neutralization.
Findings limited to small first-in-human study in healthy adults aged 18-55 with 51 participants, not yet tested for efficacy in immunocompromised patients.
Evidence
- Peer-reviewedThe Journal of Infectious Diseases2026-07-14
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Truvace Impact Record TRV-2026-0225, v1: “Randomized, Double-Blind, Placebo-Controlled First-in-Human Trial of a First-in-Class AI-Designed Monoclonal Antibody (GB-0669) Against the Conserved SARS-CoV-2 Spike S2 Stem Helix.” Truvace, 2026-07-15. /record/TRV-2026-0225 (accessed at citation time). sha256 3cb561397ac9c678…
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