drugset / Trial / NCT02254993
Phase 2, Open-Label Study for Safety, Microbiology and PK of Single or Multiple Oral C16G2 Gel Doses
Non-randomizedParallel-groupOpen-labelPrevention
Summary
Part A: Open-label, multiple arm, safety, microbiology and pharmacokinetic (PK) study in healthy adult male and female subjects 18-75 years of age. All subjects will be assessed for safety and microbiology parameters. A subset of subjects will be assessed for pharmacokinetic parameters. No longer enrolling study subjects in Part A. Part B: Open-label, multiple arm, safety and microbiology study in healthy adult male and female subjects 18-75 years of age. All subjects will be assessed for safety, pharmacokinetic, and microbiology parameters.
Timeline
- Start
- 2014-10
- Primary completion
- 2015-06
- Completion
- 2015-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | C16G2 | Peptide | 1.6 mg/ml | Oral |
| Subject | C16G2 | Peptide | 3.2 mg/ml | Oral |