NCT05011812

Study of PBI-0451 in Healthy Subjects.

A Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of PBI-0451 in Healthy Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Pardes Biosciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

Summary

This is a phase 1, placebo-controlled, blinded, randomized, dose escalation study of PBI-0451 in healthy subjects. PBI-0451 is a new chemical entity and inhibitor of the main protease of coronaviruses, including the SARS-CoV-2 that causes COVID-19 disease. The study is designed to evaluate the safety, tolerability and pharmacokinetics of PBI-0451 after single and multiple ascending doses and also to explore drug-drug interaction potential of PBI-0451.

Detailed description

Combined Three part, double blind, (sponsor open) study. Part 1: Single ascending dose study. Part 2: Multiple ascending dose study. Part 3: Drug-drug interaction study.

Conditions

• Covid19

Interventions

Type	Name	Description
DRUG	PBI-0451 Dose 1	Dose level 1 of PBI-0451
DRUG	PBI-0451 Dose 2	Dose level 2 of PBI-0451
DRUG	PBI-0451 Dose 3	Dose level 3 of PBI-0451
DRUG	PBI-0451 Dose 4	Dose level 4 of PBI-0451
DRUG	Ritonavir	Ritonavir will be co-administered with the study drug in Treatments J and K
DRUG	Midazolam	Midazolam will be co-administered with the study drug in Treatment L
DRUG	Placebo	Placebo to match
DRUG	PBI-0451	Dose level of PBI-0451 with a projected exposure
DRUG	PBI-0451 Dose 5	Dose level 5 of PBI-0451

Timeline

• Start date: 2021-08-14
• Primary completion: 2022-03-26
• Completion: 2022-03-26
• First posted: 2021-08-18
• Last updated: 2022-06-03

Locations

1 site across 1 country: New Zealand