Study of PBI-0451 in Healthy Subjects.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-14

Study Completion Date

2022-03-26

Brief Summary

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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.

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Detailed Description

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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

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Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Open to Sponsor

Study Groups

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Part 1, Treatment A

Dose level 1 of PBI-0451

Group Type EXPERIMENTAL

PBI-0451 Dose 1

Intervention Type DRUG

Dose level 1 of PBI-0451

Placebo

Intervention Type DRUG

Placebo to match

Part 1, Treatment B

Dose level 2 of PBI-0451

Group Type EXPERIMENTAL

PBI-0451 Dose 2

Intervention Type DRUG

Dose level 2 of PBI-0451

Placebo

Intervention Type DRUG

Placebo to match

Part 1, Treatment C

Dose level 3 of PBI-0451

Group Type EXPERIMENTAL

PBI-0451 Dose 3

Intervention Type DRUG

Dose level 3 of PBI-0451

Placebo

Intervention Type DRUG

Placebo to match

Part 1, Treatment D

Dose level 4 of PBI-0451

Group Type EXPERIMENTAL

PBI-0451 Dose 4

Intervention Type DRUG

Dose level 4 of PBI-0451

Placebo

Intervention Type DRUG

Placebo to match

Part 2, Treatment E

PBI-0451 =/\< Dose level 1

Group Type EXPERIMENTAL

PBI-0451 Dose 1

Intervention Type DRUG

Dose level 1 of PBI-0451

Placebo

Intervention Type DRUG

Placebo to match

Part 2, Treatment F

PBI-0451 =/\< Dose level 2

Group Type EXPERIMENTAL

PBI-0451 Dose 2

Intervention Type DRUG

Dose level 2 of PBI-0451

Placebo

Intervention Type DRUG

Placebo to match

Part 2, Treatment G

PBI-0451 =/\< Dose level 3

Group Type EXPERIMENTAL

PBI-0451 Dose 3

Intervention Type DRUG

Dose level 3 of PBI-0451

Placebo

Intervention Type DRUG

Placebo to match

Part 2, Treatment H

PBI-0451 =/\< Dose level 4

Group Type EXPERIMENTAL

PBI-0451 Dose 4

Intervention Type DRUG

Dose level 4 of PBI-0451

Placebo

Intervention Type DRUG

Placebo to match

Part 3, Treatment J

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

Group Type EXPERIMENTAL

Ritonavir

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Placebo to match

PBI-0451

Intervention Type DRUG

Dose level of PBI-0451 with a projected exposure

Part 3, Treatment K

PBI-0451 + ritonavir

Group Type EXPERIMENTAL

Ritonavir

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Placebo to match

PBI-0451

Intervention Type DRUG

Dose level of PBI-0451 with a projected exposure

Part 3, Treatment L

PBI-0451 dose TBD

\+ midazolam (a sensitive CYP450 3A substrate)

Group Type EXPERIMENTAL

Midazolam

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Placebo to match

PBI-0451

Intervention Type DRUG

Dose level of PBI-0451 with a projected exposure

Part 1, Treatment M

Dose level 2 of PBI-0451 with food

Group Type EXPERIMENTAL

PBI-0451 Dose 2

Intervention Type DRUG

Dose level 2 of PBI-0451

Placebo

Intervention Type DRUG

Placebo to match

Part 2, Treatment I

PBI-0451 =/\< Dose level 5

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Placebo to match

PBI-0451 Dose 5

Intervention Type DRUG

Dose level 5 of PBI-0451

Part 1, Treatment N

Dose Level 5 of PBI-0451

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Placebo to match

PBI-0451 Dose 5

Intervention Type DRUG

Dose level 5 of PBI-0451

Interventions

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PBI-0451 Dose 1

Dose level 1 of PBI-0451

Intervention Type DRUG

PBI-0451 Dose 2

Dose level 2 of PBI-0451

Intervention Type DRUG

PBI-0451 Dose 3

Dose level 3 of PBI-0451

Intervention Type DRUG

PBI-0451 Dose 4

Dose level 4 of PBI-0451

Intervention Type DRUG

Ritonavir

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

Intervention Type DRUG

Midazolam

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

Intervention Type DRUG

Placebo

Placebo to match

Intervention Type DRUG

PBI-0451

Dose level of PBI-0451 with a projected exposure

Intervention Type DRUG

PBI-0451 Dose 5

Dose level 5 of PBI-0451

Intervention Type DRUG

Other Intervention Names

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PBI-0451 PBI-0451 PBI-0451 PBI-0451 Norvir PBi-0451

Eligibility Criteria

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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

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes