SuspendedNot Applicable

First-in-Human Safety Study for Fractomer™ Biomatrix

Stopped: Investigation into mild/moderate delayed reactions.

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 (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.

Who can participate

Age range

22 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants with fever

Timeframe: Periodically over six weeks

Number of participants with abnormal blood chemistry measures

Timeframe: Periodically over six weeks

Number of participants with abnormal hematology results.

Timeframe: Periodically over six weeks

Number of participants with abnormal coagulation results.

Timeframe: Periodically over six weeks

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

Timeframe: Periodically over six weeks

Number of participants with subjective signs of systemic response.

Timeframe: Periodically over six weeks

Number of participants with rejection or extrusion of the injection

Timeframe: Periodically over six weeks

Trial details

NCT IDNCT07151638

SponsorinSoma Bio, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12-22

View on ClinicalTrials.gov More Soft Tissue trials

Plain-language summary

Who can participate

Age range

22 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of participants with fever

Timeframe: Periodically over six weeks

Number of participants with abnormal blood chemistry measures

Timeframe: Periodically over six weeks

Number of participants with abnormal hematology results.

Timeframe: Periodically over six weeks

Number of participants with abnormal coagulation results.

Timeframe: Periodically over six weeks

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

Timeframe: Periodically over six weeks

Number of participants with subjective signs of systemic response.

Timeframe: Periodically over six weeks

Number of participants with rejection or extrusion of the injection

Timeframe: Periodically over six weeks