๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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