First-in-Human Safety Study for Fractomer™ Biomatrix

NCT07151638 | Completed FDA Device

• 1 other identifier: FRA-001
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate the safety of implanting a new medical device (Fractomer™ 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.

Conditions

Soft Tissue; Soft Tissue Defects; Subcutaneous Injection

Outcome Measures

Primary Outcomes (8)

• Number of participants with fever

  Each participant's temperature and signs of fever will be measured at each in-person visit as a measure of potential systemic reaction to the implanted device.

  Periodically over six weeks

• Number of participants with abnormal blood chemistry measures

  Participants will undergo blood draws at in-person visits to monitor serum chemistry. Any abnormal results that the investigator considers of concern will be flagged for follow-up. Each participant's blood chemistry will be measured at each in-person visit and evaluated as a measure of potential systemic reaction to the implanted device.

  Periodically over six weeks

• Number of participants with abnormal hematology results.

  Participants will undergo blood draws at in-person visits to monitor hematology/CBC profile. Any abnormal results that the investigator considers of concern will be flagged for follow-up. Each participant's CBC profile will be measured at each in-person visit and evaluated as a measure of potential systemic reaction to the implanted device.

  Periodically over six weeks

• Number of participants with abnormal coagulation results.

  Participants will undergo blood draws at in-person visits to monitor their coagulation profile. Any abnormal results that the investigator considers of concern will be flagged for follow-up. Each participant's coagulation profile will be measured at each in-person visit and evaluated as a measure of potential systemic reaction to the implanted device.

  Periodically over six weeks

• Number of participants with local signs of irritation or toxicity (observed at injection site)

  Participants will be examined at each in-person visit for any redness, swelling, bruising, pain, or tenderness at the injection site.

  Periodically over six weeks

• Number of participants with subjective signs of systemic response.

  Participants will undergo check-ins with investigators at in-person visits to monitor subjective signs of systemic reactions, including severe headaches or serious malaise. Any signs that the investigator considers of concern will be flagged for follow-up.

  Periodically over six weeks

• Number of participants with rejection or extrusion of the injection

  Participants will undergo check-ins with investigators at in-person visits to monitor the injection site, including an examination for any evidence of rejection or extrusion of the implanted device.

  Periodically over six weeks

• Number of SAEs

  Participants will undergo check-ins with investigators at in-person visits to monitor their health. Any SAE which is considered by the investigator to be injection- or device-related will be detailed and followed up per the protocol.

  Periodically over six weeks

Secondary Outcomes (1)

• Participant cellular responses to implanted device.

  After the six week explant timepoint.

Study Arms (2)

Fractomer A

EXPERIMENTAL

Participants will be implanted with Fractomer A.

Device: Implantation (injection) of a new biomatrix for soft tissue support.

Fractomer B

EXPERIMENTAL

Participants will be implanted with Fractomer B

Device: Implantation (injection) of a new biomatrix for soft tissue support.

Interventions

Implantation (injection) of a new biomatrix for soft tissue support. DEVICE

Implantation of a new injectable medical device, Fractomer Biomatrix, to study the safety of the product in healthy human participants.

Also known as: Fractomer, implantable, bioresorbable medical device

Fractomer A; Fractomer B

Eligibility Criteria

• Age: 22 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• \. Participants with ongoing, stable anxiety and/or depression may be included, provided that they are stable and do not require the use of concomitant medications.
• \. Ability to receive an injection of Fractomer™ and be willing to have a biopsy of the injection area be taken after either six weeks or three months.
• \. For a person of child-bearing potential (POCBP)2: participant has a negative urine pregnancy test and has agreed to use contraceptives3 prior to and during their clinical trial participation.
• \. BMI of 24 to 39.9, inclusive.

You may not qualify if:

• \. Participant has, or the investigator believes them to have, a condition that would interfere with their ability to provide written informed consent, comply with study instructions, attend follow up visits, or which might confound the interpretation of the study results or put the subject at undue risk.
• \. Participants with any current or previous illness that, in the opinion of the investigator, might confound the results of the study or pose an additional, unacceptable risk to the participant or that could prevent, limit, or confound the protocol-specified assessments or study results' interpretation.
• \. Participant has or had a recent serious or ongoing infection, or risk for serious infection, or acute or chronic infection defined by the presence of any of the following:
• 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.
• History of splenectomy.
• Participant has hepatitis B or C virus or liver disease.
• Participant has a known seropositivity for, or active human immunodeficiency virus (HIV) infection.
• Participant is undergoing chemotherapy or has a history of malignancy
• Participant has collagen or elastin-vascular disease or other auto-immune disease.
• Participant is on immunosuppressive therapy.
• Or other condition(s) as indicated by the Investigator. 4. Participant has a history of type 1 or type 2 diabetes. 5. Participant has an allergy to lidocaine or epinephrine. 6. Participant has a hypersensitivity or allergy to adhesive tape. 7. Participant is pregnant or lactating. 8. Participant has a history of allergy or hypersensitivity to collagen or elastin injections.
• \. Participant is hypertensive (blood pressure 140/90 mmHg or higher), has cardiac or valvular disease, has a pacemaker or defibrillator, or has a known abdominal aortic aneurysm.

Sponsors & Collaborators

• inSoma Bio, Inc.: lead

Study Sites (1)

Nucleus Network

Saint Paul, Minnesota, 55114, United States

Location

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Trisha Shamp, PhD, PA-C

  Nucleus Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: September 3, 2025
• Study Start: August 11, 2025
• Primary Completion: October 22, 2025
• Study Completion: November 5, 2025
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

US (1)