Clinical trial
A Single Center, Prospective, Double-blind, Balanced, Randomized, Two-treatment, Single-period, Single Ascending Dose (SAD) and Multiple-dose, Parallel, Phase I, Study to Compare the Safety, Tolerability and Pharmacokinetics of Test Formulation VRP-034 (Novel Formulation of Polymyxin B 500,000 IU) of Venus Remedies Limited vs Commercially Available Polymyxin B for Injection USP (Poly-MxB) 500,000 IU in Normal Healthy Adult Male Human Subjects
NCT07502144 is registered in ClinicalTrials.gov with Venus Remedies Limited as lead sponsor.
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Registry record
As filed in ClinicalTrials.gov.
- Title
- A Single Center, Prospective, Double-blind, Balanced, Randomized, Two-treatment, Single-period, Single Ascending Dose (SAD) and Multiple-dose, Parallel, Phase I, Study to Compare the Safety, Tolerability and Pharmacokinetics of Test Formulation VRP-034 (Novel Formulation of Polymyxin B 500,000 IU) of Venus Remedies Limited vs Commercially Available Polymyxin B for Injection USP (Poly-MxB) 500,000 IU in Normal Healthy Adult Male Human Subjects
- Lead sponsor
- Venus Remedies Limited
- Phase
- Phase 1
- Overall status
- Not yet recruiting
- Start date
- April 30, 2026
- Completion date
- December 31, 2026
- Enrollment
- 48 (estimated)
- Sites
- 1
Conditions
As the registry lists them; a condition with its own page is linked.
healthy volunteers