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CompletedNCT05011812Updated Jun 3, 2022

Study of PBI-0451 in Healthy Subjects.

A Phase 1 interventional study of PBI-0451 Dose 1 and PBI-0451 Dose 2 in Covid19, sponsored by Pardes Biosciences, Inc.. Completed at 1 site in New Zealand. Open to participants aged 18 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-03.

Sponsored by Pardes Biosciences, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
18 Years to 59 Years
Sex
All
01

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.

Read the 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.

02

Conditions studied

  • Covid19
03

In context

Lead sponsor

Pardes Biosciences, Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 59 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Non-smoking, healthy male or female subjects aged 18-59 years.
  2. Body Mass Index (BMI) of ≥ 19.0 and ≤ 30.0 kg/m2.
  3. 12-Lead electrocardiogram (ECG) evaluation without clinically significant abnormalities.
  4. Normal renal function, including having a creatinine clearance (CLcr) ≥90mL/min
  5. Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.
  6. Screening laboratory assessments must be without clinically significant abnormalities as assessed by the investigator.

Exclusion criteria

Exclusion Criteria:

  1. Pregnant and lactating females
  2. Have received any investigational drug (or vaccine) within the last 30 days prior to study dosing.
  3. Have a positive test result for HIV or HBsAg.
  4. Have poor venous access that limits phlebotomy
  5. Have taken any prescription medications or over-the-counter medications, including herbal products and dietary supplements within 28 days prior to start of study.
  6. Have been treated with systemic steroids, immunosuppressant therapies, or chemotherapeutic agents within 3 months prior to Screening or is expected to receive these agents during the study.
  7. Have a history of lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
  8. Have a history of significant drug sensitivity, cardiac disease, syncope, palpitations, or unexplained dizziness, implanted defibrillator or pacemaker, liver disease, severe peptic ulcer disease, gastroesophageal reflux disease and a medical or surgical treatment that permanently altered gastric absorption.
  9. Have received inactivated vaccinations within 4 weeks prior to randomization or receive live vaccinations within 4 weeks of Screening.
  10. Received the COVID-19 vaccine either within 7 days or have not completed the series of required 2 doses.
  11. Have a history of excessive alcohol use or other illicit drug use within 6 months of screening.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
130 participants (actual)

Study arms

  • Experimental
    Part 1, Treatment A

    Dose level 1 of PBI-0451

    Drug: PBI-0451 Dose 1 · Drug: Placebo

  • Experimental
    Part 1, Treatment B

    Dose level 2 of PBI-0451

    Drug: PBI-0451 Dose 2 · Drug: Placebo

  • Experimental
    Part 1, Treatment C

    Dose level 3 of PBI-0451

    Drug: PBI-0451 Dose 3 · Drug: Placebo

  • Experimental
    Part 1, Treatment D

    Dose level 4 of PBI-0451

    Drug: PBI-0451 Dose 4 · Drug: Placebo

  • Experimental
    Part 2, Treatment E

    PBI-0451 =/\< Dose level 1

    Drug: PBI-0451 Dose 1 · Drug: Placebo

  • Experimental
    Part 2, Treatment F

    PBI-0451 =/\< Dose level 2

    Drug: PBI-0451 Dose 2 · Drug: Placebo

  • Experimental
    Part 2, Treatment G

    PBI-0451 =/\< Dose level 3

    Drug: PBI-0451 Dose 3 · Drug: Placebo

  • Experimental
    Part 2, Treatment H

    PBI-0451 =/\< Dose level 4

    Drug: PBI-0451 Dose 4 · Drug: Placebo

  • Experimental
    Part 3, Treatment J

    PBI-0451 + ritonavir (a CYP450 3A inhibitor)

    Drug: Ritonavir · Drug: Placebo · Drug: PBI-0451

  • Experimental
    Part 3, Treatment K

    PBI-0451 + ritonavir

    Drug: Ritonavir · Drug: Placebo · Drug: PBI-0451

  • Experimental
    Part 3, Treatment L

    PBI-0451 dose TBD + midazolam (a sensitive CYP450 3A substrate)

    Drug: Midazolam · Drug: Placebo · Drug: PBI-0451

  • Experimental
    Part 1, Treatment M

    Dose level 2 of PBI-0451 with food

    Drug: PBI-0451 Dose 2 · Drug: Placebo

  • Experimental
    Part 2, Treatment I

    PBI-0451 =/\< Dose level 5

    Drug: Placebo · Drug: PBI-0451 Dose 5

  • Experimental
    Part 1, Treatment N

    Dose Level 5 of PBI-0451

    Drug: Placebo · Drug: PBI-0451 Dose 5

Interventions

  • DrugPBI-0451 Dose 1

    Dose level 1 of PBI-0451

    Also known as: PBI-0451

  • DrugPBI-0451 Dose 2

    Dose level 2 of PBI-0451

    Also known as: PBI-0451

  • DrugPBI-0451 Dose 3

    Dose level 3 of PBI-0451

    Also known as: PBI-0451

  • DrugPBI-0451 Dose 4

    Dose level 4 of PBI-0451

    Also known as: PBI-0451

  • DrugRitonavir

    Ritonavir will be co-administered with the study drug in Treatments J and K

    Also known as: Norvir

  • DrugMidazolam

    Midazolam will be co-administered with the study drug in Treatment L

  • DrugPlacebo

    Placebo to match

  • DrugPBI-0451

    Dose level of PBI-0451 with a projected exposure

  • DrugPBI-0451 Dose 5

    Dose level 5 of PBI-0451

    Also known as: PBi-0451

06

What researchers measure

Primary outcomes

  1. Number of subjects with treatment emergent adverse events (TEAEs) in Single Ascending Dose (SAD) compared to placebo

    An adverse event is any untoward medical occurrence in patient or clinical study participant temporarily associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) is defined as any untoward medical occurrence at any dose that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect. AEs include both SAEs and AEs. TAEs are AEs that occur following the start of treatment or AEs increasing in severity during treatment.

    Time frame: Day 1- Day 14 (From start of study medication till 14 days of last administration of study drug)

  2. Number of subjects with clinically significant change from Baseline in vital signs in SAD

    Vital signs include blood pressure, heart rate, respiratory rate, and temperature

    Time frame: Day 1-Day 14 (From start of study medication till 14 days of last administration of study drug)

  3. Number of patients with laboratory abnormalities in SAD

    Hematology and serum chemistry

    Time frame: Day 1-Day 14 (From start of study medication till 14 days of last administration of study drug)

  4. Number of subjects with treatment emergent adverse events (TEAEs) in Multiple Ascending Dose (MAD) compared to placebo

    An adverse event is any untoward medical occurrence in patient or clinical study participant temporarily associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) is defined as any untoward medical occurrence at any dose that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect. AEs include both SAEs and AEs. TAEs are AEs that occur following the start of treatment or AEs increasing in severity during treatment.

    Time frame: Day 1-Day 11, and Follow up (after 14 days)

  5. Number of subjects with clinically significant change from Baseline in vital signs in MAD

    Vital signs include blood pressure, heart rate, respiratory rate, and temperature

    Time frame: Day 1-Day 11, and Follow up (after 14 days)

  6. Number of patients with laboratory abnormalities in MAD

    Hematology and serum chemistry

    Time frame: Day 1-Day 11, and Follow up (after 14 days)

Secondary outcomes

  1. To collect ECG data for PBI-0451 for the purpose of concentration-QT/QTc modeling

    Criteria for clinically significant changes in ECG (12 lead) are defined as: a postdose QTc interval increase by =/\>30msec from the baseline and is \>450 msec; or an absolute QTc value is =/\> 500 msec for any scheduled ECG.

    Time frame: Day 1, 4, 6 and 11

  2. Plasma concentration of each dose of study drug to determine AUCinf in SAD

    AUCinf = Area under the plasma concentration versus time curve (AUC) from time 0 to extrapolated infinite time.

    Time frame: Day 1-Day 6

  3. Plasma concentration of each dose of study drug to determine AUClast in SAD

    AUClast is summarized by dosing regimen and determined by linear/log trapezoidal method.

    Time frame: Day 1-Day 6

  4. Plasma concentration of each dose of study drug to determine %AUCexp in SAD

    %AUCexp is summarized by dosing regimen and expressed as area under the plasma concentration-time curve extrapolated from time (tau) to infinity as a percentage of total AUC

    Time frame: Day 1-Day 6

  5. Plasma concentration of each dose of study drug to determine CL/F in SAD

    CL/F is a measure of the rate at which a drug is metabolized or eliminated by normal biological process

    Time frame: Day 1-Day 6

  6. Plasma concentration of each dose of study drug to determine CLss/F in MAD

    CLss/F is the total body clearance for extravascular administration divided by the fraction of dose absorbed

    Time frame: Day 4, Day 6, Day 8

  7. Plasma concentration of each dose of study drug to determine AUCtau in MAD

    Area under the plasma concentration- Time profile from Time zero to end of dosing interval. AUCtau is summarized by dosing regimen and period.

    Time frame: Day 4, Day 6, Day 8

  8. Plasma concentration of each dose of study drug to determine Cmax in MAD

    Observed Cmax is estimated based on the plasma concentrations.

    Time frame: Day 4, Day 6, Day 8 (Pre dose to 24 hours)

  9. Plasma concentration of each dose of study drug to determine Tmax in MAD

    Tmax is summarized by dosing regimen

    Time frame: Day 4, Day 6, Day 8 (Pre dose to 24 hours)

  10. Plasma concentration of each dose of study drug to determine Tlast in MAD

    Tlast is the time of last measurable concentration

    Time frame: Day 4, Day 6, Day 8

  11. Plasma concentration of each dose of study drug to determine Clast in MAD

    Clast is the last measurable concentration (above the quantification limit)

    Time frame: Day 4, Day 6, Day 8

  12. Plasma concentration of each dose of study drug to determine Ctau in MAD

    Ctau is the concentration at the end of dosing interval

    Time frame: Day 4, Day 6, Day 8

  13. Plasma concentration of each dose of study drug to determine λz in MAD

    Individual estimate of terminal elimination rate constant, calculated using log-linear regression of the terminal portions of the plasma concentration-versus-time curves.

    Time frame: Day 4, Day 6, Day 8

  14. Plasma concentration of each dose of study drug to determine t1/2

    t1/2 is summarized by dosing regimen . It is determined by loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log linear concentration time curve. Only those data points judged to describe the terminal log linear decline is used in the regression.

    Time frame: Day 1(0 hours- 24 hours post dose), Day 4, Day 6, Day 8

  15. Plasma concentration of each dose of study drug to determine Vz/F

    Vz/F is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. VZ/F after oral dose is influenced by the fraction absorbed.

    Time frame: Day 4, Day 6, Day 8

07

Study locations

1 site
  • Auckland City Hospital
    Auckland, 1010, New Zealand
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05011812
Lead sponsor
Pardes Biosciences, Inc.
Responsible party
Sponsor
First posted
Aug 18, 2021
Start date
Aug 14, 2021
Primary completion
Mar 26, 2022
Completion
Mar 26, 2022
Last update
Jun 3, 2022

Study contacts

Mark Marshall
principal investigator · New Zealand Clinical Research

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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