Clinical Trial to Investigate the Safety, Tolerability and Pharmacokinetics of BV100 in Male Subjects
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Healthy Subjects
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Sequential AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: double-blindPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 55 years
- Gender
- Only males
Description
The purpose of this First in human study is to evaluate the safety, tolerability, and pharmacokinetics of single intravenous ascending doses of BV100 to healthy subjects. Participants will either receive one single intravenous infusion of BV100 or placebo (physiological saline 0.9% w/v).
The purpose of this First in human study is to evaluate the safety, tolerability, and pharmacokinetics of single intravenous ascending doses of BV100 to healthy subjects. Participants will either receive one single intravenous infusion of BV100 or placebo (physiological saline 0.9% w/v).
Tracking Information
- NCT #
- NCT04636983
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Denis Strugala, MD Nuvisan GmbH
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