PMID-40131143 – Safety of Intravenous Infusion of BPC157 in Humans
Lee E, Burgess K. "Safety of Intravenous Infusion of BPC157 in Humans: A Pilot Study," Alternative Therapies in Health and Medicine, 2025.
Quick Reference
| Property | Value |
|---|---|
| PMID | 40131143 |
| DOI | — |
| Year | 2025 |
| Journal | Alternative Therapies in Health and Medicine |
| Study Type | Case Series |
| Evidence Level | IV |
| Sample | n=2 healthy human adults |
| Peptide(s) Studied | BPC-157 |
Key Findings
- First published study evaluating IV administration of BPC-157 in humans
- IRB-approved pilot study in 2 healthy adults receiving IV BPC-157 at doses up to 20 mg
- No adverse effects observed on cardiac, hepatic, renal, thyroid, or glucose biomarkers
- IV BPC-157 was well-tolerated at both 10 mg and 20 mg doses
- Establishes preliminary human safety data for the IV route of administration
Study Design
Open-label, IRB-approved pilot study in 2 healthy adult volunteers. Subjects received escalating IV doses of BPC-157 (10 mg and 20 mg). Comprehensive metabolic panels, cardiac markers, thyroid function, and glucose monitoring were assessed before and after administration.
Limitations
- Extremely small sample size (n=2) — no statistical power for safety conclusions
- No placebo control or blinding
- Single-dose assessment; no data on repeated dosing safety
- Published in a complementary/alternative medicine journal, not a mainstream pharmacology journal
- Short follow-up period; long-term safety unknown
Clinical Relevance
While the sample size is too small for definitive safety conclusions, this is historically significant as the first published human IV safety data for BPC-157. The absence of adverse effects at doses up to 20 mg IV provides preliminary reassurance but requires validation in larger Phase 1 trials. Note: NCT02637284 (Phase 1 PK/safety trial, Croatia) remains status unknown since 2015.
Related
#research #case-series #evidence-level-IV