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Assess the Gluten Degradation Activity of PvP001 and PvP002 in Healthy Adult Volunteers

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ClinicalTrials.gov Identifier: NCT03701555
Recruitment Status : Recruiting
First Posted : October 10, 2018
Last Update Posted : October 10, 2018
Sponsor:
Information provided by (Responsible Party):
PvP Biologics, Inc.

Brief Summary:
This study has two parts. Each part of the study begins with a Screening Period of up to 4 weeks to allow for completion of screening procedures and subject scheduling. Each subject will be screened by means of medical history, medication review, Gastrointestinal Symptoms Questionnaire (GSQ), physical examination, vital signs, weight, height, laboratory tests, and ECG.

Condition or disease Intervention/treatment Phase
Digestive System Disease Other: PvP001 placebo Drug: PvP001 100 mg Drug: PvP001 300 mg Drug: PvP001 900 mg Drug: Maximum Feasible Dose (MFD) of PvP002 Drug: Maximum Tolerated Dose (MTD) of PvP001 Drug: MTD of PvP001 following 7 days of PPI treatment Other: PvP002 placebo Phase 1

Detailed Description:

This study has two parts. Each part of the study begins with a Screening Period of up to 4 weeks to allow for completion of screening procedures and subject scheduling. Each subject will be screened by means of medical history, medication review, Gastrointestinal Symptoms Questionnaire (GSQ), physical examination, vital signs, weight, height, laboratory tests, and ECG. The GSQ is being used as a separate safety monitoring tool in this study to ensure that all gastrointestinal complaints are reported by the subject.

Following completion of all screening procedures, eligible subjects will be enrolled in the study. Part 1 of the study in healthy subjects will be completed prior to enrollment of any subject in Part 2 of the study. A subject enrolled in Part 1 of the study will participate in one of five dose Cohorts. Enrollment of healthy subjects in each of the five dose Cohorts will occur sequentially. Enrollment of patients with CeD in each of the five dose Cohorts will occur sequentially, but each of these dose Cohorts will be open to enrollment only after demonstration of the safety and tolerability of the same dose level in healthy subjects. A healthy subject enrolled in Part 2 of the study will participate in one of two Groups; within Group 1 and Group 2, each subject will be randomized to the treatment order. Enrollment of subjects in Group 1 and Group 2 may occur in parallel. A subject may participate in only one part/group of the study (i.e., either Part 1, Part 2 Group 1, or Part 2 Group 2).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: A Ph1 Study to Assess the Safety, Tolerability, and Pk of PvP001 and PvP002 in Healthy Adult Volunteers and Adults With Celiac Disease and to Assess the Gluten Degradation Activity of PvP001and PvP002 in Healthy Adult Volunteers
Actual Study Start Date : June 19, 2018
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort 1A-1 to 1D-1 Healthy Subjects
A single dose of PvP001 placebo, PvP001 100 mg, PvP001300 mg, or PvP001 900 mg will be administered in ascending order to healthy subjects in Cohorts 1A-1, 1B-1, 1C-1, and 1D-1
Other: PvP001 placebo
placebo

Drug: PvP001 100 mg
PvP001 100 mg

Drug: PvP001 300 mg
PvP001 300 mg

Drug: PvP001 900 mg
PvP001 900 mg

Experimental: Cohort 1E-1 Healthy Subjects
A single dose of the Maximum Feasible Dose (MFD) of PvP002 will then be administered to healthy subjects in Cohort 1E-1
Drug: Maximum Feasible Dose (MFD) of PvP002
Maximum Feasible Dose (MFD) of PvP002

Experimental: Cohort 1A-2 - 1D-2 Celiac Disease (CeD)
A single dose of PvP001 placebo, PvP001 100 mg, PvP001 300 mg, or PvP001 900 mg will be administered in ascending order to patients with CeD in Cohorts 1A-2, 1B-2, 1C-2, and 1D-2
Other: PvP001 placebo
placebo

Drug: PvP001 100 mg
PvP001 100 mg

Drug: PvP001 300 mg
PvP001 300 mg

Drug: PvP001 900 mg
PvP001 900 mg

Experimental: Cohort 1E-2 Celiac Disease (CeD)
A single dose of the Maximum Feasible Dose (MFD) of PvP002 will then be administered to patients with CeD in Cohort 1E-2
Drug: Maximum Feasible Dose (MFD) of PvP002
Maximum Feasible Dose (MFD) of PvP002

Placebo Comparator: Cohort 2A - Cohort 2C Healthy Subjects
Participants will be blinded to the PvP001 dose (placebo or the Maximum Tolerated Dose (MTD) of PvP001) and will also receive MTD of PvP001 following 7 days of PPI treatment
Other: PvP001 placebo
placebo

Drug: Maximum Tolerated Dose (MTD) of PvP001
Maximum Tolerated Dose (MTD) of PvP001

Drug: MTD of PvP001 following 7 days of PPI treatment
Maximum Tolerated Dose (MTD) of PvP001 following 7 days of PPI (Proton Pump Inhibitor) treatment

Experimental: Cohort 2B Healthy Subjects
Participants will be blinded to the PvP001 dose (placebo or the Maximum Tolerated Dose (MTD) of PvP001)
Other: PvP001 placebo
placebo

Drug: Maximum Tolerated Dose (MTD) of PvP001
Maximum Tolerated Dose (MTD) of PvP001

Experimental: Cohort 2E Healthy Subjects
Participants will receive the PvP002 placebo and the Maximum Feasible Dose (MFD) of PvP002
Drug: Maximum Feasible Dose (MFD) of PvP002
Maximum Feasible Dose (MFD) of PvP002

Other: PvP002 placebo
Placebo




Primary Outcome Measures :
  1. Part 1: Percentage of Participants reporting Type, frequency, severity, and relatedness of treatment emergent adverse events (TEAEs) with PvP001 [ Time Frame: 1 week ]
    Part 1: Percentage of Participants reporting Type, frequency, severity, and relatedness of treatment emergent adverse events (TEAEs) with PvP001


Secondary Outcome Measures :
  1. Part 1: Percentage of Participants reporting treatment emergent serious adverse events (TESAEs) with PvP001 [ Time Frame: up to 5 weeks ]
    Part 1: Percentage of Participants reporting treatment emergent serious adverse events (TESAEs) with PvP001

  2. Part 1: Percentage of Participants with changes in electrocardiograms (ECGs) findings with PvP001 [ Time Frame: 1 week ]
    Part 1: Percentage of Participants with changes in electrocardiograms (ECGs) findings with PvP001

  3. Part 1: Percentage of Participants with clinically significant changes in vital signs findings with PvP001 [ Time Frame: 1 week ]
    Part 1: Percentage of Participants with clinically significant changes in vital signs findings with PvP001

  4. Part 1: Percentage of Participants with clinically significant changes in physical examination findings with PvP001 [ Time Frame: 1 week ]
    Part 1: Percentage of Participants with clinically significant changes in physical examination findings with PvP001

  5. Part 1: Percentage of Participants with clinically significant laboratory abnormalities findings with PvP001 [ Time Frame: 1 week ]
    Part 1: Percentage of Participants with clinically significant laboratory abnormalities findings with PvP001

  6. Part 1: Percentage of Participants reporting Type, frequency, severity, and relatedness of TEAEs with PvP002 [ Time Frame: 1 week ]
    Part 1: Percentage of Participants reporting Type, frequency, severity, and relatedness of TEAEs with PvP002

  7. Part 1: Percentage of Participants reporting Treatment Emergent Serious Adverse Events with PvP002 [ Time Frame: 1 week ]
    Part 1: Percentage of Participants reporting Treatment Emergent Serious Adverse Events with PvP002

  8. Part 1: Percentage of Participants with changes in ECGs with PvP002 [ Time Frame: 1 week ]
    Part 1: Percentage of Participants with changes in ECGs with PvP002

  9. Part 1: Percentage of Participants with clinically significant changes in vital signs with PvP002 [ Time Frame: 1 week ]
    Part 1: Percentage of Participants with clinically significant changes in vital signs with PvP002

  10. Part 1: Percentage of Participants with clinically significant changes in physical examination findings with PvP002 [ Time Frame: 1 week ]
    Part 1: Percentage of Participants with clinically significant changes in physical examination findings with PvP002

  11. Part 1: Percentage of Participants with clinically significant changes in laboratory abnormalities findings with PvP002 [ Time Frame: 1 week ]
    Part 1: Percentage of Participants with clinically significant changes in laboratory abnormalities findings with PvP002

  12. Part 2: Percentage of Gluten degradation by PvP001 in a standardized 3 g gluten-containing study meal after administration of PvP001 [ Time Frame: 1 day ]
    Part 2: Percentage of Gluten degradation by PvP001 in a standardized 3 g gluten-containing study meal after administration of PvP001

  13. Part 2: Percentage of Gluten degradation by PvP002 in a standardized 3 g gluten-containing study meal after administration of PvP001 [ Time Frame: 1 day ]
    Part 2: Percentage of Gluten degradation by PvP002 in a standardized 3 g gluten-containing study meal after administration of PvP001

  14. Part 2: Percentage of Gluten degradation by PvP001 in a standardized 3 g gluten-containing study meal following 7 days of standard dose PPI (Proton Pump Inhibitor) treatment [ Time Frame: 1 day ]
    Part 2: Percentage of Gluten degradation by PvP001 in a standardized 3 g gluten-containing study meal following 7 days of standard dose PPI (Proton Pump Inhibitor) treatment

  15. Part 1: Area under the Plasma Concentration versus Time Curve (AUC) of PvP001 [ Time Frame: 24 hours ]
    Part 1: Area under the Plasma Concentration versus Time Curve (AUC) of PvP001

  16. Part 1: Number of Participants with Anti-drug Antibodies (ADA ) to PvP001 [ Time Frame: 28 days ]
    Part 1: Number of Participants with Anti-drug Antibodies (ADA ) to PvP001

  17. Part 1: Area under the Plasma Concentration versus Time Curve (AUC) of PvP002 [ Time Frame: 24 hours ]
    Part 1: Area under the Plasma Concentration versus Time Curve (AUC) of PvP002

  18. Part 1: Percentage of Participants with Anti-drug Antibodies (ADA ) to PvP002 [ Time Frame: 28 days ]
    Part 1: Percentage of Participants with Anti-drug Antibodies (ADA ) to PvP002

  19. Part 1: Maximum Tolerated Dose (MTD) of PvP001 for use in Part 2 of the study [ Time Frame: 28 days ]
    Part 1: Maximum Tolerated Dose (MTD) of PvP001 for use in Part 2 of the study

  20. Part 2: Percentage of Participants reporting Type, frequency, severity, and relatedness of treatment emergent adverse events (TEAEs) with PvP001 [ Time Frame: up to 4 weeks ]
    Part 2: Percentage of Participants reporting Type, frequency, severity, and relatedness of treatment emergent adverse events (TEAEs) with PvP001

  21. Part 2: Percentage of Participants reporting Treatment Emergent Serious Adverse Events (TESAEs) with PvP001 [ Time Frame: up to 4 weeks ]
    Part 2: Percentage of Participants reporting Treatment Emergent Serious Adverse Events (TESAEs) with PvP001

  22. Part 2: Percentage of Participants with changes in electrocardiograms (ECGs) findings with PvP001 [ Time Frame: up to 4 weeks ]
    Part 2: Percentage of Participants with changes in electrocardiograms (ECGs) findings with PvP001

  23. Part 2: Percentage of Participants with clinically significant changes in vital signs findings with PvP001 [ Time Frame: up to 4 weeks ]
    Part 2: Percentage of Participants with clinically significant changes in vital signs findings with PvP001

  24. Part 2: Percentage of Participants with clinically significant changes in physical examination findings with PvP001 [ Time Frame: up to 4 weeks ]
    Part 2: Percentage of Participants with clinically significant changes in physical examination findings with PvP001

  25. Part 2: Percentage of Participants with clinically significant laboratory abnormalities findings with PvP002 [ Time Frame: up to 4 weeks ]
    Part 2: Percentage of Participants with clinically significant laboratory abnormalities findings with PvP002

  26. Part 2: Area under the Plasma Concentration versus Time Curve (AUC) of PvP001 [ Time Frame: up to 480 minutes ]
    Part 2: Area under the Plasma Concentration versus Time Curve (AUC) of PvP001

  27. Part 2: Percentage of Participants with Anti-drug Antibodies (ADA ) to PvP001 [ Time Frame: up to 8 weeks ]
    Part 2: Percentage of Participants with Anti-drug Antibodies (ADA ) to PvP001

  28. Part 2: Percentage of Participants reporting Type, frequency, severity, and relatedness of TEAEs with PvP002 [ Time Frame: up to 4 weeks ]
    Part 2: Percentage of Participants reporting Type, frequency, severity, and relatedness of TEAEs with PvP002

  29. Part 2: Percentage of Participants reporting Treatment Emergent Serious Adverse Events with PvP002 [ Time Frame: up to 4 weeks ]
    Part 2: Percentage of Participants reporting Treatment Emergent Serious Adverse Events with PvP002

  30. Part 2: Percentage of Participants with changes in ECGs with PvP002 [ Time Frame: up to 4 weeks ]
    Part 2: Percentage of Participants with changes in ECGs with PvP002

  31. Part 2: Percentage of Participants with clinically significant changes in vital signs with PvP002 [ Time Frame: up to 4 weeks ]
    Part 2: Percentage of Participants with clinically significant changes in vital signs with PvP002

  32. Part 2: Percentage of Participants with clinically significant changes in physical examination findings with PvP002 [ Time Frame: up to 4 weeks ]
    Part 2: Percentage of Participants with clinically significant changes in physical examination findings with PvP002

  33. Part 2: Percentage of Participants with clinically significant changes in laboratory abnormalities findings with PvP002 [ Time Frame: up to 4 weeks ]
    Part 2: Percentage of Participants with clinically significant changes in laboratory abnormalities findings with PvP002

  34. Part 2: Area under the Plasma Concentration versus Time Curve (AUC) of PvP002 [ Time Frame: up to 480 minutes ]
    Part 2: Area under the Plasma Concentration versus Time Curve (AUC) of PvP002

  35. Part 2: Percentage of Participants with Anti-drug Antibodies (ADA ) to PvP002 [ Time Frame: up to 8 weeks ]
    Part 2: Percentage of Participants with Anti-drug Antibodies (ADA ) to PvP002



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Part 1 and Part 2

  • Male or female age 18- 59 years, inclusive
  • No relevant gastrointestinal symptoms
  • Able to abstain from alcohol for 72 hours prior to the Screening Visit, Cohort Treatment Day, and Final Safety Visit (Part 2), and for 72 hours after the Cohort Treatment Day
  • A female subject must have a negative pregnancy test at Screening and prior to each treatment day visit, and agree to birth control measures (e.g., abstinence, a stable hormonal contraceptive, double-barrier method, or vasectomy in partner) for the study duration
  • A male subject must agree to acceptable birth control measures (e.g., abstinence, latex condom, or vasectomy), or must have a female partner who will continue birth control measures (e.g., abstinence, a stable hormonal contraceptive, or double-barrier method) for the study duration
  • Able to read and understand English
  • Able to provide written informed consent

Additional Inclusion Criteria for Part 1 and Part 2 Healthy Adult Volunteers

  • No use of over-the-counter or prescription medication, except for birth control medications for the duration of the study
  • No history of gastrointestinal diseases or disorders
  • No history of intolerance, sensitivity, or reactions to gluten or any other food or food ingredient
  • Able to maintain a gluten-free diet for 24 hours prior to the designated study visits

Additional Inclusion Criteria for Part 1 Patients with Celiac Disease

  • Documented history of Celiac Disease in medical records
  • Maintaining a gluten-free diet for ≥6 months
  • No use of over-the-counter or prescription medication, except for birth control medications and those allowed by the study doctor, for the duration of the study.
  • No history of gastrointestinal diseases or disorders, other than Celiac Disease
  • No history of intolerance, hypersensitivity, or reaction to any food or food ingredient
  • Able to continue a gluten-free diet for the duration of the study

Exclusion Criteria:

Part 1 and Part 2

  • Current symptoms or signs of illness
  • Chronic viral infection or immunodeficiency condition
  • Any female who is pregnant, planning to become pregnant during the study, or breast-feeding; any male who is planning to father a child during the study
  • Receipt (or planned receipt) of another investigational medication within 4 weeks prior to the Screening Visit through the duration of the study
  • Alcohol consumption >5 drinks/week, alcohol consumption within 72 hours prior to any study visit, or a positive alcohol breathalyzer test at any study visit
  • History of illicit or recreational drug use within the three years prior to the Screening Visit, or a positive urine drug screen at any study visit
  • Use of tobacco or nicotine products, including smoking, smokeless tobacco, e-cigarettes, or nicotine replacement products within 12 months prior to the Screening Visit through the duration of the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03701555


Contacts
Contact: Justyna Kloda 8582753644 justyna@pvpbio.com

Locations
United States, California
Anaheim Clinical Trials Recruiting
Anaheim, California, United States, 92801
Contact: Peter Winkle, MD    714-774-7777    pwinkle@agmg.com   
Sponsors and Collaborators
PvP Biologics, Inc.
Investigators
Principal Investigator: Peter Winkle, MD Anaheim Clinical Trials

Responsible Party: PvP Biologics, Inc.
ClinicalTrials.gov Identifier: NCT03701555     History of Changes
Other Study ID Numbers: PvP-102-01
First Posted: October 10, 2018    Key Record Dates
Last Update Posted: October 10, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Digestive System Diseases
Gastrointestinal Diseases