NCT05011812

Study of PBI-0451 in Healthy Subjects.

Completed Phase 1 Last updated 3 June 2022

What this trial tests

Phase 1 trial testing PBI-0451 Dose 1 in Covid19 in 130 participants. Completed in 26 March 2022.

Timeline

14 August 2021

Primary endpoint
26 March 2022

26 March 2022

Quick facts

Lead sponsor	Pardes Biosciences, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	130
Start date	14 August 2021
Primary completion	26 March 2022
Estimated completion	26 March 2022
Sites	1 location across New Zealand

Drugs / interventions tested

• PBI-0451 Dose 1 — full drug profile →
• PBI-0451 Dose 2
• PBI-0451 Dose 3
• PBI-0451 Dose 4
• Ritonavir (ritonavir) — full drug profile →
• Midazolam (midazolam) — full drug profile →
• Placebo
• PBI-0451
• PBI-0451 Dose 5

Conditions studied

• Covid19 — all drugs for Covid19 →

Sponsor

Pardes Biosciences, Inc. — full company profile →

Who can join

Adults 18 to 59, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The SARS-CoV-2 main protease (M^pro): Structure, function, and emerging therapies for COVID-19.
   Hu Q, Xiong Y, Zhu GH, Zhang YN, et al · · 2022 · cited 136× · PMID 35845352 · DOI 10.1002/mco2.151
2. On the origins of SARS-CoV-2 main protease inhibitors.
   Janin YL. · · 2024 · cited 22× · PMID 38283212 · DOI 10.1039/d3md00493g
3. Evaluation of <i>in vitro</i> antiviral activity of SARS-CoV-2 M<sup>pro</sup> inhibitor pomotrelvir and cross-resistance to nirmatrelvir resistance substitutions.
   Tong X, Keung W, Arnold LD, Stevens LJ, et al · · 2023 · cited 21× · PMID 37800975 · DOI 10.1128/aac.00840-23
4. Inhibitors of SARS-CoV-2 Main Protease (Mpro) as Anti-Coronavirus Agents.
   Zagórska A, Czopek A, Fryc M, Jończyk J. · · 2024 · cited 19× · PMID 39062511 · DOI 10.3390/biom14070797
5. Recent advances in small-molecular therapeutics for COVID-19.
   Zhong L, Zhao Z, Peng X, Zou J, et al · · 2022 · cited 15× · PMID 36268466 · DOI 10.1093/pcmedi/pbac024
6. Precursors of Viral Proteases as Distinct Drug Targets.
   Majerová T, Novotný P. · · 2021 · cited 15× · PMID 34696411 · DOI 10.3390/v13101981
7. Review of preclinical data of PF-07304814 and its active metabolite derivatives against SARS-CoV-2 infection.
   Chen W, Shao Y, Peng X, Liang B, et al · · 2022 · cited 11× · PMID 36438815 · DOI 10.3389/fphar.2022.1035969
8. A comprehensive evaluation in clinic and physiologically-based pharmacokinetic modeling and simulation to confirm lack of cytochrome P450-mediated drug-drug interaction potential for pomotrelvir.
   Yang Z, Rioux N, Vincent L, Jones HM, et al · · 2023 · cited 2× · PMID 37614073 · DOI 10.1002/psp4.13034