Phase 1
N=48
Safety, Tolerability and Pharmacokinetics of Benfo-Oxythiamine (B-OT) in Healthy Volunteers
Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT07450833 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) — 1; 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Benfo-oxythiamine (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Benfovir AG
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
1; 0; 0; 0; 0; 3 | — |
| PRIMARY Number of Participants With Serious Adverse Events (SAEs) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Abnormalities in Safety Laboratory Assessments |
0; 0; 0; 0; 0; 1 | — |
| PRIMARY Number of Participants With Clinically Significant Abnormalities in Vital Signs |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Abnormalities in 12-Lead Electrocardiogram (ECG) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Abnormal Physical Examination Findings |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Single Ascending Dose (SAD): Maximum Plasma Concentration (Cmax) of Oxythiamine |
1.12; 2.30; 4.21; 8.46; 15.5 | — |
| SECONDARY Single Ascending Dose (SAD): Area Under the Curve (AUC0-t) of Oxythiamine |
3.36; 9.81; 23.7; 41.1; 85.4 | — |
| SECONDARY Single Ascending Dose (SAD): Area Under the Curve Infinity (AUC0-inf) of Oxythiamine |
3.91; 10.7; 25.5; 43.1; 87.4 | — |
| SECONDARY Single Ascending Dose (SAD): Time to Maximum Concentration (Tmax) of Oxythiamine |
1.67; 1.67; 1.75; 1.67; 2.50 | — |
| SECONDARY Single Ascending Dose (SAD): Terminal Elimination Half-Life (t1/2) of Oxythiamine |
1.82; 2.90; 9.41; 10.5; 12.1 | — |
| SECONDARY Single Ascending Dose (SAD): Apparent Body Clearance (CL/F) of Oxythiamine |
128; 94.9; 86.0; 70.4; 60.5 | — |
| SECONDARY Single Ascending Dose (SAD): Apparent Volume of Distribution (Vz/F) of Oxythiamine |
336; 399; 1191; 1074; 955 | — |
| SECONDARY Multiple Ascending Dose (MAD) Day 1: Maximum Plasma Concentration (Cmax) of Oxythiamine |
2.16; 5.19; 9.91; 14.3 | — |
| SECONDARY Multiple Ascending Dose (MAD) Day 1: Area Under the Curve (AUC0-tau) of Oxythiamine |
8.93; 27.3; 43.7; 82.0 | — |
| SECONDARY Multiple Ascending Dose (MAD) Day 1: Time to Maximum Concentration (Tmax) of Oxythiamine |
1.33; 1.83; 1.93; 2.58 | — |
| SECONDARY Multiple Ascending Dose (MAD) Day 7: Steady State Maximum Plasma Concentration (Cmax,ss) of Oxythiamine |
2.76; 6.27; 9.38; 15.4 | — |
| SECONDARY Multiple Ascending Dose (MAD) Day 7: Steady State Minimum Plasma Concentration (Cmin,ss) of Oxythiamine |
0.18; 0.31; 0.43; 0.69 | — |
| SECONDARY Multiple Ascending Dose (MAD) Day 7: Steady State Average Plasma Concentration (Cav) of Oxythiamine |
0.66; 1.56; 2.24; 3.86 | — |
| SECONDARY Multiple Ascending Dose (MAD) Day 7: Trough Concentration (Ctrough) of Oxythiamine |
0.19; 0.33; 0.52; 0.78 | — |
| SECONDARY Multiple Ascending Dose (MAD) Day 7: Steady State Area Under the Curve (AUCtau) of Oxythiamine |
15.8; 49.8; 76.1; 134 | — |
| SECONDARY Multiple Ascending Dose (MAD) Day 7: Area Under the Curve Infinity (AUC0-inf) of Oxythiamine |
19.3; 55.2; 83.4; 143 | — |
| SECONDARY Multiple Ascending Dose (MAD) Day 7: Steady State Time to Maximum Concentration (Tmax,ss) of Oxythiamine |
1.92; 1.75; 1.92; 1.58 | — |
| SECONDARY Multiple Ascending Dose (MAD) Day 7: Terminal Elimination Half-Life (t1/2) of Oxythiamine |
12.1; 27.5; 36.2; 44.9 | — |
| SECONDARY Multiple Ascending Dose (MAD) Day 7: Steady State Apparent Body Clearance (CLss/F) of Oxythiamine |
65.1; 55.0; 56.1; 56.0 | — |
| SECONDARY Multiple Ascending Dose (MAD) Day 7: Steady State Apparent Volume of Distribution (Vss/F) of Oxythiamine |
1112; 643; 761; 666 | — |
| SECONDARY Multiple Ascending Dose (MAD) Day 7: Steady State Fluctuation (Swing) of Oxythiamine |
15.7; 18.6; 20.8; 22.3 | — |
| SECONDARY Multiple Ascending Dose (MAD) Day 7: Peak-Trough Fluctuation (PTF) of Oxythiamine |
382; 344; 380; 377 | — |
| SECONDARY Multiple Ascending Dose (MAD): Accumulation Ratio for Maximum Concentration (Ra Cmax) of Oxythiamine |
1.27; 1.21; 0.96; 1.08 | — |
| SECONDARY Multiple Ascending Dose (MAD): Accumulation Ratio for Area Under the Curve (Ra AUCtau) of Oxythiamine |
1.84; 1.40; 1.29; 1.13 | — |
Summary
The goal of this clinical trial was to learn about the safety and tolerability of an investigational drug called Benfo-oxythiamine (B-OT) in healthy male volunteers. Researchers are studying B-OT to see if it might be used to treat infectious diseases and cancer. This study also looked at how the drug enters, moves through, and leaves the body.
The main questions it aimed to answer were:
* Is B-OT safe for humans to take?
* What medical problems do participants have when taking B-OT?
* How much of the drug gets into the blood?
Participants:
* Took B-OT capsules by mouth either once (single dose group) or once a day for 7 days (multiple dose group).
* Stayed in the clinic for several days (4 to 8 nights) for close monitoring.
* Gave blood and urine samples for laboratory tests;
* Had physical exams, heart rhythm checks (ECG), and vital sign checks (blood pressure, heart rate, breathing rate, and temperature).
Eligibility Criteria
Inclusion Criteria
- Signed and dated informed consent form.
- Subjects capable to understand the purposes and risks of the study.
- Male volunteers willing to comply with contraception requirements.
- Aged 18-60 years, inclusive.
- Healthy participants, as determined by screening assessments and Principal Investigator's judgment (absence of active/chronic disease).
- Body Mass Index (BMI) of 18-30 kg/m² inclusive.
- Male participants with female partners of childbearing potential must agree to be abstinent or use a male condom plus partner use of a contraceptive method.
Exclusion Criteria
- Clinically relevant history of respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, or connective tissue disorders.
- Fridericia's correction factor for QT (QTcF) > 450 ms or history of QT interval prolongation.
- Acute gastrointestinal symptoms at screening/admission.
- Any abnormal laboratory value of Grade 2 or higher considered clinically significant.
- Values ≥ 10% above upper limit of normal for ALT, AST, Alkaline Phosphatase, Creatinine, or Urea.
- Clinically relevant surgical history.
- History of relevant drug hypersensitivity, alcoholism, or drug abuse.
- Significant infection or known inflammatory process.
- Use of prescription/non-prescription medicines within 2 weeks of admission.
- Receipt of investigational drug within 30 days prior to screening.
- Use of tobacco/nicotine products within 3 months of screening.
- Positive alcohol or drug screen.
- Blood donation within 3 months prior to screening.
- Vaccinated with a Covid-19 vaccine within 2 weeks prior to screening.
Data sourced from ClinicalTrials.gov (NCT07450833). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.