Hamstring Muscle StrainPhase 2BPC-HAMSTRNCT07437547
BPC 157 for Acute Hamstring Muscle Strain Repair
A Phase 2 study testing Pentadecapeptide BPC 157 in people with Hamstring Muscle Strain and Skeletal Muscle Injury, run by Hudson Biotech at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Hamstring Muscle Strain, Skeletal Muscle Injury
- What is being tested?
- Pentadecapeptide BPC 157
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 2 Feb 2026to 17 Feb 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036
Zhen J Peng, Phd, +86 13076790039, Zhen-Peng@beijing-biotech.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Hamstring Muscle Strain, Skeletal Muscle Injury
- Being tested
- Pentadecapeptide BPC 157, Placebo
- Keywords
- BPC 157, BPC-157, pentadecapeptide, muscle strain, hamstring injury, sports medicine, MRI, return to play, muscle repair, rehabilitation
- Medical subject headings
- Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pentadecapeptide BPC 157Drug
subcutaneous injection (administered by trained study staff). Schedule: once daily for 14 days.
PlaceboDrug
subcutaneous injection (administered by trained study staff). Schedule: once daily for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Experimental - BPC 157 | Experimental | Participants receive investigational pentadecapeptide BPC 157 plus standardized rehabilitation. Receives: Drug: Pentadecapeptide BPC 157; Drug: Placebo |
| Arm 2: Placebo Comparator - Placebo | Experimental | Participants receive matching placebo plus standardized rehabilitation. Receives: Drug: Pentadecapeptide BPC 157; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 Weeks
Change from baseline to Day 14 in MRI-assessed hamstring injury volume (cm^3), measured by blinded central radiology review.
Measured: 14 Days
Secondary outcomes (3)
Change in pain during activity on a 0-10 Numeric Rating Scale (NRS; 0 = no pain, 10 = worst pain).
Measured: 56 Days
Hamstring strength limb symmetry index (LSI) by isokinetic dynamometry
Measured: 56 Days
Change in Lower Extremity Functional Scale (LEFS; 0-80, higher scores indicate better function)
Measured: 56 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start2 Feb 2026
- Primary completion14 Feb 2027 (estimated)
- Study completion17 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hamstring Muscle StrainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hudson Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07437547
- Sponsor's protocol ID
- BH-BPC157-MUSC-001
- Acronym
- BPC-HAMSTR
- Status last verified
- Feb 2026
- First submitted
- 22 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07437547
- Acronym / sponsor ID
- BPC-HAMSTR / BH-BPC157-MUSC-001
- Conditions
- Hamstring Muscle Strain, Skeletal Muscle Injury
- Keywords
- BPC 157, BPC-157, pentadecapeptide, muscle strain, hamstring injury, sports medicine, MRI, return to play
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hudson BiotechIndustry (pharma, biotech, devices)
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 14 Feb 2027 (estimated)
- Study completion
- 17 Feb 2028 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Experimental - BPC 157 | Experimental | Drug: Pentadecapeptide BPC 157, Drug: PlaceboParticipants receive investigational pentadecapeptide BPC 157 plus standardized rehabilitation. |
| Arm 2: Placebo Comparator - Placebo | Experimental | Drug: Pentadecapeptide BPC 157, Drug: PlaceboParticipants receive matching placebo plus standardized rehabilitation. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pentadecapeptide BPC 157subcutaneous injection (administered by trained study staff). Schedule: once daily for 14 days. | Drug | Arm 1: Experimental - BPC 157, Arm 2: Placebo Comparator - Placebo |
| Placebosubcutaneous injection (administered by trained study staff). Schedule: once daily for 14 days. | Drug | Arm 1: Experimental - BPC 157, Arm 2: Placebo Comparator - Placebo |
Primary outcome
Time to return to unrestricted sport participation (days)
Time frame: 8 Weeks
defined as clearance by a blinded sports medicine clinician and completion of a standardized functional performance battery without pain-limited stopping.
Change from baseline to Day 14 in MRI-assessed hamstring injury volume (cm^3), measured by blinded central radiology review.
Time frame: 14 Days
3 secondary outcomes
Change in pain during activity on a 0-10 Numeric Rating Scale (NRS; 0 = no pain, 10 = worst pain).
Time frame: 56 Days
Hamstring strength limb symmetry index (LSI) by isokinetic dynamometry
Time frame: 56 Days
Change in Lower Extremity Functional Scale (LEFS; 0-80, higher scores indicate better function)
Time frame: 56 Days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pentadecapeptide BPC 157 in people with Hamstring Muscle Strain and Skeletal Muscle Injury, run by Hudson Biotech at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seni S Lu, Phd (+86 13076790030, Seni-Lu@beijing-biotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to return to unrestricted sport participation (days) (time frame: 8 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.