First-in-Human Safety Study for Fractomerâ„¢ Biomatrix (NCT07151638) | Clinical Trial Compass
CompletedNot Applicable
First-in-Human Safety Study for Fractomerâ„¢ Biomatrix
United States2 participantsStarted 2025-08-11
Plain-language summary
The goal of this clinical trial is to evaluate the safety of implanting a new medical device (Fractomerâ„¢ Biomatrix) in healthy volunteers. The main question it aims to answer is:
How do healthy volunteers react to this injectable implant?
Participants will receive a subcutaneous injection of Fractomer and their health will be monitored. After the monitoring period, the implant will be removed.
Who can participate
Age range22 Years – 55 Years
SexALL
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Inclusion criteria
✓. Provision of signed and dated informed consent form.
✓. Stated willingness to comply with all study procedures and availability for the duration of the study.
✓. Male or female, aged 22 to 55.
✓. Participants must be deemed by the Investigator to be generally healthy individuals based on a medical evaluation that includes a physical examination, medical history, vital signs, and the results from clinical, laboratory and other safety assessments collected during the Screening period. For medical history, there must be an absence of clinically significant diagnosis (in the opinion of the Investigator) of cardiovascular, dermatologic, endocrine, gastrointestinal, infectious, hematologic, hepatic, immunologic, metabolic, oncologic, neurologic, psychiatric, renal, or respiratory disease that may increase the risk of the participant in this study.
Exclusion criteria
✕. History of recurrent infections (defined as ≥ 3 infections requiring antimicrobial therapy within the 12 months prior to Screening).
✕. Hospitalization for infection or receipt of a course of intravenous (IV) antimicrobial therapy within 8 weeks prior to screening OR an opportunistic infection requiring hospitalization or IV antimicrobial treatment within 1 year of screening.
✕. Clinically significant chronic infection (e.g., osteomyelitis, bronchiectasis) within 8 weeks prior to Screening.
✕. Any herpes zoster, cytomegalovirus (CMV), or Epstein-Barr virus (EBV) infection that has not completely resolved within 12 weeks prior to Screening.
✕
What they're measuring
1
Number of participants with fever
Timeframe: Periodically over six weeks
2
Number of participants with abnormal blood chemistry measures
Timeframe: Periodically over six weeks
3
Number of participants with abnormal hematology results.
Timeframe: Periodically over six weeks
4
Number of participants with abnormal coagulation results.
Timeframe: Periodically over six weeks
5
Number of participants with local signs of irritation or toxicity (observed at injection site)
Timeframe: Periodically over six weeks
6
Number of participants with subjective signs of systemic response.
Timeframe: Periodically over six weeks
7
Number of participants with rejection or extrusion of the injection