A First in Human Study of the Safety, Tolerability, and the Physiologically Based Pharmacokinetic… (NCT05361733) | Clinical Trial Compass
RecruitingPhase 1
A First in Human Study of the Safety, Tolerability, and the Physiologically Based Pharmacokinetics of XFB19 in Healthy Adult Volunteers.
United States40 participantsStarted 2026-02-17
Plain-language summary
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.
Who can participate
Age range18 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the study, including possible risks and adverse effects.
✓. Adult males and females, 18 to 55 years of age (inclusive) at screening.
✓. Body mass index ≥ 18.0 and ≤ 35.0 kg/m2 with a body weight ≥ 45 kg at screening.
✓. Be non-smokers (including tobacco, e-cigarettes, and marijuana) for at least 1 month prior to first investigational drug administration.
✓. Medically healthy without clinically significant abnormalities (in the opinion of the Investigator) at the Screening Visit and prior to dosing including:
✓. Physical examination without any clinically significant findings
✓. Systolic blood pressure in the range of 90 to 160 mmHg (inclusive) and diastolic blood pressure in the range of 50 to 95 mmHg (inclusive) after 5 minutes rest in supine position
✓. Heart rate (HR) in the range of 40 to 100 bpm (inclusive) after 5 minutes rest in supine position
Exclusion criteria
✕. History or presence of any clinically significant (as determined by the PI) cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, or neurological disease, including any acute illness or major surgery, within the past 3 months.
✕. Current infection that requires systemically absorbed antibiotic, antifungal, antiparasitic, or antiviral medications.
What they're measuring
1
Number of participants with adverse events
Timeframe: During admission to the clinical unit (up to 10 days)
2
Heart Rate (assessed by ECG)
Timeframe: During admission to the clinical unit (up to 10 days)
3
Rhythm (assessed by ECG)
Timeframe: During admission to the clinical unit (up to 10 days)
4
P wave (assessed by ECG)
Timeframe: During admission to the clinical unit (up to 10 days)
5
PR interval (assessed by ECG)
Timeframe: During admission to the clinical unit (up to 10 days)
6
QRS complex (assessed by ECG)
Timeframe: During admission to the clinical unit (up to 10 days)
7
ST segment (assessed by ECG)
Timeframe: During admission to the clinical unit (up to 10 days)
8
T wave (assessed by ECG)
Timeframe: During admission to the clinical unit (up to 10 days)
✕. Any history of malignant disease in the last 5 years (excluding surgically resected skin squamous cell or basal cell carcinoma).
✕. Presence of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions such as common variable hypogammaglobulinemia.
✕. Use of or plans to use systemic immunosuppressive (e.g., corticosteroids, methotrexate, azathioprine, cyclosporine) or immunomodulating medications (e.g., interferon) during the study or within 3 months prior to the first study drug administration.
✕. History of risk factors for torsade de pointes (including a family history of long QT syndrome or sudden cardiac death) or a known arrythmia.
✕. Liver function test (LFT) results \> 1.5 times the upper limit of normal (ULN) for gamma glutamyl transferase (GGT), bilirubin (total, conjugated, and unconjugated), alkaline phosphatase (ALP), aspartate aminotransferase (AST), or alanine aminotransferase (ALT). Volunteers with bilirubin, ALP and/or ALT/AST above the limits specified may be included, at the discretion of the Investigator, if the levels are unaccompanied by clinical signs.
✕. Positive test results for human immunodeficiency virus (HIV-1 or HIV-2) antibodies, hepatitis C virus (HCV) antibodies, or hepatitis B surface antigen (HBsAg) at the Screening Visit. Patients with HCV antibodies, or HBsAg could be included if the viral load for HCV or hepatitis B are negative.
9
QT interval (assessed by ECG)
Timeframe: During admission to the clinical unit (up to 10 days)
10
Cardiac axis (assessed by ECG)
Timeframe: During admission to the clinical unit (up to 10 days)
11
J-point (assessed by ECG)
Timeframe: During admission to the clinical unit (up to 10 days)