Evaluation of the Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Participants With Acute Respiratory Distress Syndrome (ARDS) Associated With at Least Severe COVID-19
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Acute Respiratory Distress Syndrome
- Sars Cov 2
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Approximately 36 participants will be enrolled sequentially into 3 cohorts. Within each cohort of 12 participants, 9 will be randomized to PLN-74809 and 3 will be randomized to placebo (3:1 ratio). In Part 1, approximately 12 participants will be randomized to Dose level 1 of PLN-74809 or placebo QD...
Approximately 36 participants will be enrolled sequentially into 3 cohorts. Within each cohort of 12 participants, 9 will be randomized to PLN-74809 and 3 will be randomized to placebo (3:1 ratio). In Part 1, approximately 12 participants will be randomized to Dose level 1 of PLN-74809 or placebo QD In Part 2, approximately 12 participants will be randomized to Dose level 2 of PLN-74809 or placebo QD In Part 3, approximately 12 participants will be randomized to Dose level 3 of PLN-74809 or placebo QD
Tracking Information
- NCT #
- NCT04565249
- Collaborators
- Not Provided
- Investigators
- Study Director: Pliant Therapeutics Pliant Therapeutics, Inc.
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