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Assess the Gluten Degradation Activity of PvP001 and PvP002 in Healthy Adult Volunteers and Adults With Celiac Disease
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.
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 59 Years|
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.
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
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|PvP Biologics, Inc.|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Peter Winkle, MD|
|Principal Investigator Affiliation||Anaheim Clinical Trials|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Digestive System Disease|
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 three Groups; within Group 1, 2 and 3, each subject will be randomized to the treatment order. A subject may participate in only one part/group of the study (i.e., either Part 1 or Part 2 Group 1, 2 or 3).
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