Trials / Terminated
TerminatedNCT03793686
A Study of Safety of PBCLN-003 Following Antibiotic Therapy in Subjects With C.Difficile-associated Diarrhea
A Phase 1 Double Blind, Randomized Clinical Study to Evaluate the Safety of Human Milk Oligosaccharides Following Antibiotic Therapy in Subjects With C. Difficile-associated Diarrhea
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 26 (actual)
- Sponsor
- Prolacta Bioscience · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This Phase I double blind, randomized clinical study to evaluate the safety of human milk oligosaccharides (HMO) is designed to assess the safety and dosage ranging of PBCLN-003 in adults with Clostridium difficile-associated diarrhea (CDAD). Within 3 dose cohort, subjects will be randomized in a 3:1 ratio to receive PBCLN-003 or placebo.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PBCLN-003 | Investigational drug |
| DRUG | Placebo | Placebo |
Timeline
- Start date
- 2018-12-06
- Primary completion
- 2020-09-01
- Completion
- 2020-09-01
- First posted
- 2019-01-04
- Last updated
- 2020-10-19
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03793686. Inclusion in this directory is not an endorsement.