Covid19Phase 1NCT05011812
Study of PBI-0451 in Healthy Subjects.
A Phase 1 study testing PBI-0451 Dose 1, PBI-0451 Dose 2 and PBI-0451 Dose 3 in people with Covid19, run by Pardes Biosciences, Inc. at 1 site in New Zealand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- PBI-0451 Dose 1, PBI-0451 Dose 2 and PBI-0451 Dose 3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteNew Zealand
- Study dates
- 14 Aug 2021to 26 Mar 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-smoking, healthy male or female subjects aged 18-59 years.
- Body Mass Index (BMI) of ≥ 19.0 and ≤ 30.0 kg/m2.
- 12-Lead electrocardiogram (ECG) evaluation without clinically significant abnormalities.
- Normal renal function, including having a creatinine clearance (CLcr) ≥90mL/min
- Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.
- Screening laboratory assessments must be without clinically significant abnormalities as assessed by the investigator.
Who cannot join
- Pregnant and lactating females
- Have received any investigational drug (or vaccine) within the last 30 days prior to study dosing.
- Have a positive test result for HIV or HBsAg.
- Have poor venous access that limits phlebotomy
- Have taken any prescription medications or over-the-counter medications, including herbal products and dietary supplements within 28 days prior to start of study.
- 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.
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- 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.
- 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.
- Have received inactivated vaccinations within 4 weeks prior to randomization or receive live vaccinations within 4 weeks of Screening.
- Received the COVID-19 vaccine either within 7 days or have not completed the series of required 2 doses.
- Have a history of excessive alcohol use or other illicit drug use within 6 months of screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of PBI-0451 in Healthy Subjects.
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PBI-0451 Dose 1Drug
Also called PBI-0451
Dose level 1 of PBI-0451
PBI-0451 Dose 2Drug
Also called PBI-0451
Dose level 2 of PBI-0451
PBI-0451 Dose 3Drug
Also called PBI-0451
Dose level 3 of PBI-0451
PBI-0451 Dose 4Drug
Also called PBI-0451
Dose level 4 of PBI-0451
RitonavirDrug
Also called Norvir
Ritonavir will be co-administered with the study drug in Treatments J and K
MidazolamDrug
Midazolam will be co-administered with the study drug in Treatment L
PlaceboDrug
Placebo to match
PBI-0451Drug
Dose level of PBI-0451 with a projected exposure
PBI-0451 Dose 5Drug
Also called PBi-0451
Dose level 5 of PBI-0451
| Study group | Role | What they receive |
|---|---|---|
| Part 1, Treatment A | Experimental | Dose level 1 of PBI-0451 Receives: Drug: PBI-0451 Dose 1; Drug: Placebo |
| Part 1, Treatment B | Experimental | Dose level 2 of PBI-0451 Receives: Drug: PBI-0451 Dose 2; Drug: Placebo |
| Part 1, Treatment C | Experimental | Dose level 3 of PBI-0451 Receives: Drug: PBI-0451 Dose 3; Drug: Placebo |
| Part 1, Treatment D | Experimental | Dose level 4 of PBI-0451 Receives: Drug: PBI-0451 Dose 4; Drug: Placebo |
| Part 2, Treatment E | Experimental | PBI-0451 =/< Dose level 1 Receives: Drug: PBI-0451 Dose 1; Drug: Placebo |
| Part 2, Treatment F | Experimental | PBI-0451 =/< Dose level 2 Receives: Drug: PBI-0451 Dose 2; Drug: Placebo |
| Part 2, Treatment G | Experimental | PBI-0451 =/< Dose level 3 Receives: Drug: PBI-0451 Dose 3; Drug: Placebo |
| Part 2, Treatment H | Experimental | PBI-0451 =/< Dose level 4 Receives: Drug: PBI-0451 Dose 4; Drug: Placebo |
| Part 3, Treatment J | Experimental | PBI-0451 + ritonavir (a CYP450 3A inhibitor) Receives: Drug: Ritonavir; Drug: Placebo; Drug: PBI-0451 |
| Part 3, Treatment K | Experimental | PBI-0451 + ritonavir Receives: Drug: Ritonavir; Drug: Placebo; Drug: PBI-0451 |
| Part 3, Treatment L | Experimental | PBI-0451 dose TBD
+ midazolam (a sensitive CYP450 3A substrate) Receives: Drug: Midazolam; Drug: Placebo; Drug: PBI-0451 |
| Part 1, Treatment M | Experimental | Dose level 2 of PBI-0451 with food Receives: Drug: PBI-0451 Dose 2; Drug: Placebo |
| Part 2, Treatment I | Experimental | PBI-0451 =/< Dose level 5 Receives: Drug: Placebo; Drug: PBI-0451 Dose 5 |
| Part 1, Treatment N | Experimental | Dose Level 5 of PBI-0451 Receives: Drug: Placebo; Drug: PBI-0451 Dose 5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1- Day 14 (From start of study medication till 14 days of last administration of study drug)
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
Measured: Day 1-Day 14 (From start of study medication till 14 days of last administration of study drug)
Number of patients with laboratory abnormalities in SAD
Hematology and serum chemistry
Measured: Day 1-Day 14 (From start of study medication till 14 days of last administration of study drug)
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.
Measured: Day 1-Day 11, and Follow up (after 14 days)
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
Measured: Day 1-Day 11, and Follow up (after 14 days)
Number of patients with laboratory abnormalities in MAD
Hematology and serum chemistry
Measured: Day 1-Day 11, and Follow up (after 14 days)
Secondary outcomes (15)
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.
Measured: Day 1, 4, 6 and 11
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.
Measured: Day 1-Day 6
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.
Measured: Day 1-Day 6
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
Measured: Day 1-Day 6
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
Measured: Day 1-Day 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
Measured: Day 4, Day 6, Day 8
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.
Measured: Day 4, Day 6, Day 8
Plasma concentration of each dose of study drug to determine Cmax in MAD
Observed Cmax is estimated based on the plasma concentrations.
Measured: Day 4, Day 6, Day 8 (Pre dose to 24 hours)
Plasma concentration of each dose of study drug to determine Tmax in MAD
Tmax is summarized by dosing regimen
Measured: Day 4, Day 6, Day 8 (Pre dose to 24 hours)
Plasma concentration of each dose of study drug to determine Tlast in MAD
Tlast is the time of last measurable concentration
Measured: Day 4, Day 6, Day 8
Plasma concentration of each dose of study drug to determine Clast in MAD
Clast is the last measurable concentration (above the quantification limit)
Measured: Day 4, Day 6, Day 8
Plasma concentration of each dose of study drug to determine Ctau in MAD
Ctau is the concentration at the end of dosing interval
Measured: Day 4, Day 6, Day 8
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.
Measured: Day 4, Day 6, Day 8
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.
Measured: Day 1(0 hours- 24 hours post dose), Day 4, Day 6, Day 8
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.
Measured: Day 4, Day 6, Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start14 Aug 2021
- Primary completion26 Mar 2022
- Study completion26 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pardes Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Marshall, Principal investigator, New Zealand Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05011812
- Sponsor's protocol ID
- PBI-0451-0001
- Status last verified
- Jun 2022
- First submitted
- 11 Aug 2021
- Last updated
- 3 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of PBI-0451 in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT05011812
- Acronym / sponsor ID
- PBI-0451-0001
- Conditions
- Covid19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Pardes Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Aug 2021 (actual)
- Primary completion
- 26 Mar 2022 (actual)
- Study completion
- 26 Mar 2022 (actual)
- First posted
- 18 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| Part 1, Treatment A | Experimental | Drug: PBI-0451 Dose 1, Drug: PlaceboDose level 1 of PBI-0451 |
| Part 1, Treatment B | Experimental | Drug: PBI-0451 Dose 2, Drug: PlaceboDose level 2 of PBI-0451 |
| Part 1, Treatment C | Experimental | Drug: PBI-0451 Dose 3, Drug: PlaceboDose level 3 of PBI-0451 |
| Part 1, Treatment D | Experimental | Drug: PBI-0451 Dose 4, Drug: PlaceboDose level 4 of PBI-0451 |
| Part 2, Treatment E | Experimental | Drug: PBI-0451 Dose 1, Drug: PlaceboPBI-0451 =/< Dose level 1 |
| Part 2, Treatment F | Experimental | Drug: PBI-0451 Dose 2, Drug: PlaceboPBI-0451 =/< Dose level 2 |
| Part 2, Treatment G | Experimental | Drug: PBI-0451 Dose 3, Drug: PlaceboPBI-0451 =/< Dose level 3 |
| Part 2, Treatment H | Experimental | Drug: PBI-0451 Dose 4, Drug: PlaceboPBI-0451 =/< Dose level 4 |
| Part 3, Treatment J | Experimental | Drug: Ritonavir, Drug: Placebo, Drug: PBI-0451PBI-0451 + ritonavir (a CYP450 3A inhibitor) |
| Part 3, Treatment K | Experimental | Drug: Ritonavir, Drug: Placebo, Drug: PBI-0451PBI-0451 + ritonavir |
| Part 3, Treatment L | Experimental | Drug: Midazolam, Drug: Placebo, Drug: PBI-0451PBI-0451 dose TBD + midazolam (a sensitive CYP450 3A substrate) |
| Part 1, Treatment M | Experimental | Drug: PBI-0451 Dose 2, Drug: PlaceboDose level 2 of PBI-0451 with food |
| Part 2, Treatment I | Experimental | Drug: Placebo, Drug: PBI-0451 Dose 5PBI-0451 =/< Dose level 5 |
| Part 1, Treatment N | Experimental | Drug: Placebo, Drug: PBI-0451 Dose 5Dose Level 5 of PBI-0451 |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Non-smoking, healthy male or female subjects aged 18-59 years.
- Body Mass Index (BMI) of ≥ 19.0 and ≤ 30.0 kg/m2.
- 12-Lead electrocardiogram (ECG) evaluation without clinically significant abnormalities.
- Normal renal function, including having a creatinine clearance (CLcr) ≥90mL/min
- Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.
Key exclusion criteria (11 listed)
- Pregnant and lactating females
- Have received any investigational drug (or vaccine) within the last 30 days prior to study dosing.
- Have a positive test result for HIV or HBsAg.
- Have poor venous access that limits phlebotomy
- Have taken any prescription medications or over-the-counter medications, including herbal products and dietary supplements within 28 days prior to start of study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PBI-0451 Dose 1Also: PBI-0451Dose level 1 of PBI-0451 | Drug | Part 1, Treatment A, Part 2, Treatment E |
| PBI-0451 Dose 2Also: PBI-0451Dose level 2 of PBI-0451 | Drug | Part 1, Treatment B, Part 1, Treatment M, Part 2, Treatment F |
| PBI-0451 Dose 3Also: PBI-0451Dose level 3 of PBI-0451 | Drug | Part 1, Treatment C, Part 2, Treatment G |
| PBI-0451 Dose 4Also: PBI-0451Dose level 4 of PBI-0451 | Drug | Part 1, Treatment D, Part 2, Treatment H |
| RitonavirAlso: NorvirRitonavir will be co-administered with the study drug in Treatments J and K | Drug | Part 3, Treatment J, Part 3, Treatment K |
| MidazolamMidazolam will be co-administered with the study drug in Treatment L | Drug | Part 3, Treatment L |
| PlaceboPlacebo to match | Drug | Part 1, Treatment A, Part 1, Treatment B, Part 1, Treatment C, Part 1, Treatment D, Part 1, Treatment M, Part 1, Treatment N, Part 2, Treatment E, Part 2, Treatment F, Part 2, Treatment G, Part 2, Treatment H, Part 2, Treatment I, Part 3, Treatment J, Part 3, Treatment K, Part 3, Treatment L |
| PBI-0451Dose level of PBI-0451 with a projected exposure | Drug | Part 3, Treatment J, Part 3, Treatment K, Part 3, Treatment L |
| PBI-0451 Dose 5Also: PBi-0451Dose level 5 of PBI-0451 | Drug | Part 1, Treatment N, Part 2, Treatment I |
Primary outcome
Number of subjects with treatment emergent adverse events (TEAEs) in Single Ascending Dose (SAD) compared to placebo
Time frame: Day 1- Day 14 (From start of study medication till 14 days of last administration of study drug)
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.
Number of subjects with clinically significant change from Baseline in vital signs in SAD
Time frame: Day 1-Day 14 (From start of study medication till 14 days of last administration of study drug)
Vital signs include blood pressure, heart rate, respiratory rate, and temperature
Number of patients with laboratory abnormalities in SAD
Time frame: Day 1-Day 14 (From start of study medication till 14 days of last administration of study drug)
Hematology and serum chemistry
Number of subjects with treatment emergent adverse events (TEAEs) in Multiple Ascending Dose (MAD) compared to placebo
Time frame: Day 1-Day 11, and Follow up (after 14 days)
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.
Number of subjects with clinically significant change from Baseline in vital signs in MAD
Time frame: Day 1-Day 11, and Follow up (after 14 days)
Vital signs include blood pressure, heart rate, respiratory rate, and temperature
Number of patients with laboratory abnormalities in MAD
Time frame: Day 1-Day 11, and Follow up (after 14 days)
Hematology and serum chemistry
15 secondary outcomes
To collect ECG data for PBI-0451 for the purpose of concentration-QT/QTc modeling
Time frame: Day 1, 4, 6 and 11
Plasma concentration of each dose of study drug to determine AUCinf in SAD
Time frame: Day 1-Day 6
Plasma concentration of each dose of study drug to determine AUClast in SAD
Time frame: Day 1-Day 6
Plasma concentration of each dose of study drug to determine %AUCexp in SAD
Time frame: Day 1-Day 6
Plasma concentration of each dose of study drug to determine CL/F in SAD
Time frame: Day 1-Day 6
Plasma concentration of each dose of study drug to determine CLss/F in MAD
Time frame: Day 4, Day 6, Day 8
Plasma concentration of each dose of study drug to determine AUCtau in MAD
Time frame: Day 4, Day 6, Day 8
Plasma concentration of each dose of study drug to determine Cmax in MAD
Time frame: Day 4, Day 6, Day 8 (Pre dose to 24 hours)
Plasma concentration of each dose of study drug to determine Tmax in MAD
Time frame: Day 4, Day 6, Day 8 (Pre dose to 24 hours)
Plasma concentration of each dose of study drug to determine Tlast in MAD
Time frame: Day 4, Day 6, Day 8
Plasma concentration of each dose of study drug to determine Clast in MAD
Time frame: Day 4, Day 6, Day 8
Plasma concentration of each dose of study drug to determine Ctau in MAD
Time frame: Day 4, Day 6, Day 8
Plasma concentration of each dose of study drug to determine λz in MAD
Time frame: Day 4, Day 6, Day 8
Plasma concentration of each dose of study drug to determine t1/2
Time frame: Day 1(0 hours- 24 hours post dose), Day 4, Day 6, Day 8
Plasma concentration of each dose of study drug to determine Vz/F
Time frame: Day 4, Day 6, Day 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Marshall principal investigator
New Zealand Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PBI-0451 Dose 1, PBI-0451 Dose 2 and PBI-0451 Dose 3 in people with Covid19, run by Pardes Biosciences, Inc. at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with treatment emergent adverse events (TEAEs) in Single Ascending Dose (SAD) compared to placebo (time frame: Day 1- Day 14 (From start of study medication till 14 days of last administration of study drug)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2022.