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New drug candidate B-OT takes first step in human safety trial

NCT ID NCT07450833

Knowledge-focused Sponsor: Benfovir AG Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tested the safety and tolerability of an experimental drug called Benfo-Oxythiamine (B-OT) in 48 healthy male volunteers. Researchers gave the drug as single or multiple daily doses and monitored participants closely for side effects, blood levels, and lab changes. The goal was to see if B-OT is safe enough to study further for possible use against infectious diseases and cancer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Benfo-oxythiamine (B-OT)
What this could lead to
If this drug proves safe, it could pave the way for future studies testing B-OT as a treatment for infectious diseases or cancer.
What could go wrong
This is a very early Phase 1 trial in only 48 healthy volunteers. It only looks at safety and how the drug moves through the body, not whether it works against any disease. Many drugs fail in later stages.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

48 people

The number who actually took part.

Started

Mar 2022

Finished

Nov 2022

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 years

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

COVID-19 Korsakoff Syndrome neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy volunteers

Contacts and locations

Locations

  • Diagnostics and Consultation Center (DCC) Convex EOOD

    Sofia, Bulgaria

More trials for these conditions

Other studies related to the condition(s) this trial covers.