BPC 157 for Acute Hamstring Muscle Strain Repair

NCT07437547 | Recruiting Phase 2 DMC

• 1 other identifier: BH-BPC157-MUSC-001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hamstring Muscle Strain; Skeletal Muscle Injury

Keywords

BPC 157; BPC-157; pentadecapeptide; muscle strain; hamstring injury; sports medicine; MRI; return to play; muscle repair; rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (2)

Arm 1: Experimental - BPC 157

EXPERIMENTAL

Participants receive investigational pentadecapeptide BPC 157 plus standardized rehabilitation.

Drug: Pentadecapeptide BPC 157; Drug: Placebo

Arm 2: Placebo Comparator - Placebo

EXPERIMENTAL

Participants receive matching placebo plus standardized rehabilitation.

Drug: Pentadecapeptide BPC 157; Drug: Placebo

Interventions

Pentadecapeptide BPC 157 DRUG

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

Arm 1: Experimental - BPC 157; Arm 2: Placebo Comparator - Placebo

Placebo DRUG

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

Arm 1: Experimental - BPC 157; Arm 2: Placebo Comparator - Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hudson Biotech: lead

Study Sites (1)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, 518036, China

RECRUITING

MeSH Terms

Conditions

Sprains and Strains

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Seni S Lu, Phd

CONTACT

+86 13076790030; Seni-Lu@beijing-biotech.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigational pharmacy prepares identical-appearing prefilled syringes labeled with a randomization code. Participants, study clinicians, investigators, and outcome assessors remain blinded to assignment. Emergency unblinding is permitted only when necessary for participant safety.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants with an acute MRI-confirmed grade II hamstring strain are randomized 1:1 to investigational BPC 157 or placebo. Both groups receive the same standardized rehabilitation program.

Study Record Dates

• First Submitted: February 22, 2026
• First Posted: February 27, 2026
• Study Start: February 2, 2026
• Primary Completion (Estimated): February 14, 2027
• Study Completion (Estimated): February 17, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

CN (1)