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RecruitingPhase 2NCT07437547

BPC 157 for Acute Hamstring Muscle Strain Repair

A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of Pentadecapeptide BPC 157 for Accelerated Repair of Acute Grade II Hamstring Strain Confirmed by MRI

Sponsor

Hudson Biotech

Enrollment

120 participants

Start Date

Feb 2, 2026

Study Type

INTERVENTIONAL

Conditions

Hamstring Muscle StrainSkeletal Muscle Injury

Summary

This randomized, double-blind, placebo-controlled Phase 2 study evaluates whether pentadecapeptide BPC 157 (BPC-157), an investigational peptide, can speed structural healing and functional recovery after an acute grade II hamstring muscle strain. Participants will receive BPC 157 or placebo for 14 days in addition to a standardized rehabilitation program. The co-primary endpoints are time to return to unrestricted sport and change in MRI-assessed injury volume at Day 14.

Eligibility

Min Age: 18 YearsMax Age: 45 Years

Inclusion Criteria6

  • Age 18 to 45 years.
  • Acute posterior thigh pain consistent with hamstring strain with onset within 72 hours prior to screening.
  • MRI-confirmed grade II hamstring strain of the biceps femoris, semitendinosus, or semimembranosus, with measurable lesion.
  • Pre-injury physical activity >= 3 sessions/week or participation in organized recreational sport.
  • Willingness to follow the standardized rehabilitation protocol and attend all study visits.
  • For participants of childbearing potential: negative pregnancy test at baseline and agreement to use effective contraception during dosing and for 30 days after last dose.

Exclusion Criteria10

  • Grade III hamstring tear, tendon avulsion, or injury requiring surgical management.
  • Concomitant lower extremity injury that would interfere with rehabilitation or outcome assessment.
  • Prior hamstring strain on the index limb within the past 6 months.
  • Use of systemic corticosteroids, anabolic agents, platelet-rich plasma, stem-cell products, or investigational peptides/growth factors within 30 days prior to screening.
  • Known bleeding disorder or current therapeutic anticoagulation.
  • Significant uncontrolled medical illness (e.g., severe cardiovascular, hepatic, or renal disease) that increases study risk.
  • Known allergy or hypersensitivity to components of the investigational product or placebo.
  • Pregnant or breastfeeding.
  • Current participation in another interventional clinical study or participation within 30 days prior to screening.
  • Currently subject to a formal anti-doping testing program (e.g., WADA/USADA-aligned) where use of an investigational peptide could create a regulatory conflict, unless explicitly approved by the relevant authority

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Interventions

DRUGPentadecapeptide BPC 157

subcutaneous injection (administered by trained study staff). Schedule: once daily for 14 days.

DRUGPlacebo

subcutaneous injection (administered by trained study staff). Schedule: once daily for 14 days.

Locations(1)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

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NCT07437547