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Study of PBI-0451 in Healthy Subjects.

NCT05011812 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2022-06-03

No results posted yet for this study

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.

Conditions

  • Covid19

Interventions

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

Sponsors & Collaborators

  • Pardes Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Mark Marshall · New Zealand Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-14
Primary Completion
2022-03-26
Completion
2022-03-26

Countries

  • New Zealand

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05011812 on ClinicalTrials.gov