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Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of BV100 in Male Subjects

NCT04636983 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2022-02-08

No results posted yet for this study

Summary

This is a Phase 1, single-centre, double-blind, randomised, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of single intravenous ascending doses of BV100 to healthy male subjects.

Conditions

  • Healthy Subjects

Interventions

DRUG

BV100

Rifabutin IV

DRUG

Placebo

Saline

Sponsors & Collaborators

  • BioVersys SAS

    lead INDUSTRY

Principal Investigators

  • Denis Strugala, MD · Nuvisan GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-09
Primary Completion
2021-12-12
Completion
2022-01-20

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04636983 on ClinicalTrials.gov