Phase 2, Open-Label Study for Safety, Microbiology and PK of Single or Multiple Oral C16G2 Gel Doses
NCT02254993 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52
Last updated 2019-08-01
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.
Conditions
- Dental Caries
Interventions
- DRUG
-
C16G2
antimicrobial peptide
Sponsors & Collaborators
-
Armata Pharmaceuticals, Inc.
lead INDUSTRY
Principal Investigators
-
Adam D Marberger, DDS · Study Center PI
-
John F Pittaway, DMD · Study Center PI
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2014-10-31
- Primary Completion
- 2015-06-30
- Completion
- 2015-07-31
Countries
- United States
Study Locations
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