XFB19 Safety Study
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to evaluate the safety and tolerability of a new treatment called XFB19 in healthy adults. Researchers will administer different doses of XFB19 via injection to observe how the body processes it and ensure its safety for future studies. Participants must be non-smokers, generally healthy, and not currently on any medication. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the unique opportunity to be among the first to receive this new treatment.
Is there any evidence suggesting that XFB19 is likely to be safe for humans?
A previous study showed that XFB-19 did not harm mice, even at doses 100 times higher than those for humans. The study found no signs of heart problems or liver issues. However, since this is the first test of XFB-19 in humans, side effects and safety in people remain unknown. This Phase 1 trial will primarily assess the drug's safety and tolerability in humans.12345
Why do researchers think this study treatment might be promising?
XFB-19 is unique because it is administered subcutaneously, which can be more convenient and less invasive compared to traditional intravenous treatments. Most current options for similar conditions often involve oral medications or IV infusions. Researchers are excited about XFB-19 because it offers a potential new mechanism of action, targeting pathways differently than existing therapies, which might result in improved effectiveness or reduced side effects. Additionally, exploring various dose levels in early phases allows for optimization of its therapeutic potential, enhancing its appeal compared to standard treatments.
What evidence suggests that XFB19 might be an effective treatment?
Research has shown that XFB-19 is a promising new treatment for diseases that cause inflammation and scarring. It is the only peptide with anti-scarring properties to recently enter clinical trials. Early studies suggest that XFB-19 might reduce scarring by affecting the processes that lead to scar-forming cell activity. Although research is still in its early stages, these initial findings indicate that XFB-19 could potentially help manage conditions that cause scarring.25678
Who Is on the Research Team?
Martina M Buck, Ph.D.
Principal Investigator
Xfibra, Inc.
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part A
Single ascending doses of XFB19 are administered to determine safety and pharmacokinetics
Treatment Part B
Multiple ascending doses of XFB19 are administered to further assess safety and pharmacokinetics
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- XFB-19
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Part A: XFB19 SC injection at the following dose levels: * Cohort A1: 5 mg (or placebo vehicle , same volume) * Cohort A2: 10 mg (or placebo vehicle , same volume) * Cohort A3: 20 mg (or placebo vehicle , same volume) Part B: XFB19 SC injection at the 2 highest acceptable dose levels from Part A: * Cohort B1: second highest acceptable dose level from Part A (or placebo vehicle , same volume) * Cohort B2: highest acceptable dose level from Part A (or placebo vehicle , same volume)
10 healthy volunteers will be randomized and assigned to the Placebo arm in Part A (Cohorts A1, A2 and A3) and Part B (Cohorts B1 and B2).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Xfibra, Inc.
Lead Sponsor
PharPoint Research, Inc.
Industry Sponsor
Safe Harbor Pharmacovigilance
Collaborator
Citations
Trial | NCT05361733
Xfibra, Inc. is conducting this clinical research study to test a potential new drug called XFB19 that is being developed for inflammatory/fibrotic diseases.
Emergent Peptides of the Antifibrotic Arsenal - PMC - NIH
XFB-19 is the only peptide with antifibrotic activity that has entered clinical trials in recent years (ClinicalTrials.gov ID: NCT05361733 ...
Xfibra, Inc. - Drug pipelines, Patents, Clinical trials
Explore Xfibra, Inc. with its drug pipeline, therapeutic area, technology platform, 1 clinical trial, 2 news, Drug:XFB-19.
Highlights on Future Treatments of IPF: Clues and Pitfalls - PMC
The INJOURNEY study evaluated the add-on therapy between pirfenidone and nintedanib with promising results in terms of safety and some ...
Pathophysiological Insights and Clinical Management ...
A Phase II/III trial is currently assessing the efficacy of this agent in patients with IPF and pulmonary fibrosis associated with interstitial lung diseases.
6.
ctv.veeva.com
ctv.veeva.com/study/a-first-in-human-study-of-the-safety-tolerability-and-pk-of-xfb-19-in-healthy-adult-volunteersA First in Human Study of the Safety, Tolerability, and the ...
Focus of the Study: Safety of XFB19. Treatments. Drug ... XFB-19 is being tested in humans. Therefore, side effects in humans are unknown.
7.
centerwatch.com
centerwatch.com/clinical-trials/listings/NCT05361733/a-first-in-human-study-of-the-safety-tolerability-and-pk-of-xfb-19-in-healthy-adult-volunteersA First-in-human Study of the Safety, Tolerability, and PK of XFB ...
Xfibra, Inc. is conducting a phase 1, randomised, double-blind, placebo-controlled, first-in-human study of the safety, tolerability, and pharmacokinetics ...
xfibra, inc.
The PEG-XFB-19 was not toxic to mice at 100-fold the therapeutic dose. There was no evidence of cardiotoxicity or inhibition of CYP-450 isoenzymes. The aims ...
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