First registered TB-500 human trial: Phase 1/2 in stable ASCVD (NCT07487363)
Provenance: registered Phase 1/2 RCT (no results yet)
ClinicalTrials.gov record NCT07487363. Page is JS-rendered; details below are from the search-engine record and corroborated by 2026 TB-500 evidence reviews. This appears to be the first registered human trial of the TB-500 (thymosin β4 17–23) fragment specifically.
Key findings
- NCT07487363 — Phase 1/2 safety & tolerability of TB-500 (thymosin β4 17–23 fragment) vs placebo in adults with stable atherosclerotic cardiovascular disease (ASCVD). Design: three sequential dose cohorts, 3:1 randomization to TB-500 or placebo, 8-week dosing + 4-week safety follow-up; cardiovascular biomarker endpoints.
- Context: a 2026 evidence review confirms no completed human efficacy trials of the TB-500 (17-aa) fragment exist; human thymosin β4 data are concentrated in ocular/cornea and wound settings, and full-length RGN-259 remains unapproved as of 2026.
Why it matters for this base
- The TB-500 KB note states “no human trials.” This is the first registered human study of the fragment itself — a credibility step for the Healing & Recovery cluster, and notable that it targets cardiovascular (not musculoskeletal) endpoints.
- Reinforces the TB4-vs-TB-500 identity angle (already an article): the trial uses a defined 17–23 fragment, underscoring that fragment ≠ full-length 43-aa TB4 — fragment results won’t validate full TB4.
Caveats
- Phase 1/2, safety-focused, dose-escalation, no results. Tests a 17–23 fragment, not full-length TB4. Not FDA-approved; research/educational use only. Cancer-risk framing (angiogenesis, cell migration/EMT) unchanged.
Corroborating sources
- ClinicalTrials.gov NCT07487363; TrimRX / Innerbody / PeptIQ 2026 TB-500 evidence reviews; preprint review of thymosin β4 / TB-500 in tissue repair (Preprints.org, 2026).