Pharmacokinetics of PN-235 in Healthy Volunteers
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Healthy Volunteers
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Sequential AssignmentMasking: Triple (Participant, Investigator, Outcomes Assessor)Masking Description: Part 1 blinded, Part 2 blinded, Part 3 unblindedPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
Description
Part 1: Approximately 40 subjects randomized into 5 cohorts to receive PN-235 or placebo as single doses. Part 2: Approximately 50 subjects enrolled into 5 cohorts to receive PN-235 or placebo once daily for 10 days. Part 3: Twelve subjects will receive single doses of PN-235 in a 4-way, randomized,...
Part 1: Approximately 40 subjects randomized into 5 cohorts to receive PN-235 or placebo as single doses. Part 2: Approximately 50 subjects enrolled into 5 cohorts to receive PN-235 or placebo once daily for 10 days. Part 3: Twelve subjects will receive single doses of PN-235 in a 4-way, randomized, crossover fashion. In total, approximately 102 subjects will participate.
Tracking Information
- NCT #
- NCT04621630
- Collaborators
- Not Provided
- Investigators
- Not Provided
Get Well Soon