Trials / Terminated
TerminatedNCT03594331
Gastric Gluten-Degradation Activity of PvP001
A Phase I, First-in-Human Single Center Study in Healthy Adult Volunteers to Assess the Gastric Gluten-Degradation Activity of PvP001
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 43 (actual)
- Sponsor
- Danielle Kim Turgeon · Academic / Other
- Sex
- All
- Age
- 18 Years – 64 Years
- Healthy volunteers
- Accepted
Summary
This is a single blind, dose escalating, placebo-controlled, crossover study of gluten-degrading drug PvP001 administered to healthy volunteers (age 18-64 years). Subjects will be randomized to one of three groups representing different levels of gluten exposure - low, medium, or high - in a single meal. Within each gluten exposure group, increasing doses of PvP001 (or placebo) will be administered.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Low-dose PvP001 | Low-dose PvP001 |
| DRUG | Medium-dose PvP001 | Medium-dose PvP001 |
| DRUG | High-dose PvP001 | High-dose PvP001 |
| DRUG | Placebo | 100 mL liquid with no drug |
Timeline
- Start date
- 2018-05-25
- Primary completion
- 2019-02-06
- Completion
- 2019-02-06
- First posted
- 2018-07-20
- Last updated
- 2019-02-15
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03594331. Inclusion in this directory is not an endorsement.