Actively Recruiting
A First in Human Study of the Safety, Tolerability, and the Physiologically Based Pharmacokinetics of XFB19 in Healthy Adult Volunteers.
Led by Xfibra, Inc. · Updated on 2026-05-01
40
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
Sponsors
X
Xfibra, Inc.
Lead Sponsor
P
PharPoint Research, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Xfibra, Inc. is conducting a Phase 1, randomized, double-blind, placebo-controlled, first-in-human study of the safety, tolerability, and physiologically-based pharmacokinetics (PK) of single and multiple ascending doses of XFB19 in healthy adult volunteers.
CONDITIONS
Official Title
A First in Human Study of the Safety, Tolerability, and the Physiologically Based Pharmacokinetics of XFB19 in Healthy Adult Volunteers.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must give written informed consent and understand the study risks and purpose
- Adults aged 18 to 55 years at screening
- Body mass index from 18.0 to 35.0 kg/m2 and weight at least 45 kg
- Non-smokers (including tobacco, e-cigarettes, marijuana) for at least 1 month before first dose
- Medically healthy with no significant abnormalities on physical exam, vital signs, lab tests, and ECG
- Female participants must be either nonchildbearing (surgically sterilized or postmenopausal) or agree to use contraception if childbearing potential
- Male participants must agree to use contraception if engaging with a partner who could become pregnant
- Suitable veins for blood sampling
- Willing and able to follow study assessments and protocol requirements
You will not qualify if you...
- History or presence of significant cardiovascular, pulmonary, liver, kidney, blood, digestive, endocrine, immune, skin, or neurological disease within past 3 months
- Current infection requiring systemic antibiotics, antifungals, antiparasitics, or antivirals
- History of cancer in last 5 years except certain skin cancers
- Relevant immunosuppression or immunodeficiency conditions
- Use or planned use of systemic immunosuppressive or immunomodulating drugs within 3 months before first dose
- History of arrhythmia or risk factors for torsade de pointes
- Abnormal liver function tests above specified limits without clinical signs
- Positive tests for HIV, hepatitis B or C unless viral load negative
- Positive COVID-19 test at screening
- Conditions affecting drug absorption, metabolism, or excretion
- Reduced kidney function (creatinine clearance less than 60 mL/min) or elevated serum creatinine
- History of substance or alcohol abuse within 12 months
- Positive drug or alcohol tests at screening or admission
- Use of medications (including herbal) within 10 days before first dose except contraceptives and occasional acetaminophen
- Significant allergic reactions interfering with study participation
- Known allergies to study drug ingredients
- Vaccinations within 10 days before first dose
- Positive pregnancy test or currently breastfeeding
- Recent blood donation or transfusion
- Participation in another investigational drug study within 30 days before first dose
- Any condition or prior therapy making participation unsuitable or likely noncompliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
AMR Clinical
Knoxville, Tennessee, United States, 37920
Actively Recruiting
Research Team
M
Mario Chojkier, M.D.
CONTACT
E
Ed Parsley, D.O
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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