BPC 157 for Acute Hamstring Muscle Strain Repair (BPC-HAMSTR)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hamstring Muscle Strain; Skeletal Muscle Injury
• Intervention / Treatment: Drug: Pentadecapeptide BPC 157; Drug: Placebo

Detailed Description

Acute hamstring strains are common in running- and field-based sports and often lead to prolonged time away from sport and a risk of recurrence. Preclinical research suggests that BPC 157 may influence pathways involved in tissue protection, angiogenesis, and repair. Human clinical evidence remains limited, so a controlled trial is needed to evaluate potential benefits and characterize safety in a musculoskeletal injury population. After screening and baseline assessments (including MRI confirmation of an acute grade II hamstring strain), eligible participants will be randomized 1:1 to receive subcutaneous BPC 157 or matching placebo once daily for 14 days. All participants will follow the same evidence-based rehabilitation protocol supervised by study physiotherapists. Clinical assessments will occur at Days 3, 7, 14, 28, and 56, with additional follow-up at 3 months after return-to-play for recurrence monitoring. Safety will be assessed through adverse event monitoring, vital signs, and standard laboratory tests. An independent Data and Safety Monitoring Committee will review unblinded safety data at predefined intervals.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Seni S Lu, Phd; Phone Number: +86 13076790030; Email: Seni-Lu@beijing-biotech.com

Study Locations

• China
  • Guangdong
    • Shenzhen, Guangdong, China, 518036
      • Recruiting
      • Peking University Shenzhen Hospital
      • Contact: Zhen J Peng, Phd; Phone Number: +86 13076790039; Email: Zhen-Peng@beijing-biotech.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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 Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: Experimental - BPC 157; Participants receive investigational pentadecapeptide BPC 157 plus standardized rehabilitation.	Drug: Pentadecapeptide BPC 157; subcutaneous injection (administered by trained study staff). Schedule: once daily for 14 days.; Drug: Placebo; subcutaneous injection (administered by trained study staff). Schedule: once daily for 14 days.
Experimental: Arm 2: Placebo Comparator - Placebo; Participants receive matching placebo plus standardized rehabilitation.	Drug: Pentadecapeptide BPC 157; subcutaneous injection (administered by trained study staff). Schedule: once daily for 14 days.; Drug: Placebo; subcutaneous injection (administered by trained study staff). Schedule: once daily for 14 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to return to unrestricted sport participation (days)	defined as clearance by a blinded sports medicine clinician and completion of a standardized functional performance battery without pain-limited stopping.	8 Weeks
Change from baseline to Day 14 in MRI-assessed hamstring injury volume (cm^3), measured by blinded central radiology review.		14 Days

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in pain during activity on a 0-10 Numeric Rating Scale (NRS; 0 = no pain, 10 = worst pain).	56 Days
Hamstring strength limb symmetry index (LSI) by isokinetic dynamometry	56 Days
Change in Lower Extremity Functional Scale (LEFS; 0-80, higher scores indicate better function)	56 Days

Collaborators and Investigators

• Sponsor: Hudson Biotech

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2026
• Primary Completion (Estimated): February 14, 2027
• Study Completion (Estimated): February 17, 2028

Study Registration Dates

• First Submitted: February 22, 2026
• First Submitted That Met QC Criteria: February 22, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 22, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: MRI; rehabilitation; sports medicine; return to play; muscle strain; muscle repair; BPC 157; BPC-157; pentadecapeptide; hamstring injury
• Additional Relevant MeSH Terms: Wounds and Injuries; Sprains and Strains
• Other Study ID Numbers: BH-BPC157-MUSC-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No