Trials / Completed
CompletedNCT02472769
IBP-9414 for the Prevention of Necrotizing Enterocolitis
A Randomized, Double Blind, Parallel-group, Dose Escalation Placebo-controlled Multicenter Study to Investigate the Safety and Tolerability of IBP-9414 Administered in Preterm Infants.
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (actual)
- Sponsor
- Infant Bacterial Therapeutics · Industry
- Sex
- All
- Age
- 48 Hours
- Healthy volunteers
- Not accepted
Summary
Two different dose levels will be evaluated in two different birth weight categories, compared to placebo with regards to safety and tolerability.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | IBP-9414 | |
| DRUG | Placebo | Sterile water |
Timeline
- Start date
- 2016-05-27
- Primary completion
- 2017-08-07
- Completion
- 2017-08-07
- First posted
- 2015-06-16
- Last updated
- 2017-12-29
Locations
15 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02472769. Inclusion in this directory is not an endorsement.