A Phase 1 Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of VBP15 in Healthy Adult Subjects
NCT ID: NCT02415439
Last Updated: 2017-03-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
86 participants
INTERVENTIONAL
2015-01-31
2016-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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VBP15- 0.1 mg/kg SAD
Subjects were orally administered a single dose of VBP15 at 0.1 mg/kg under fasted conditions.
VBP15
VBP15- 0.3 mg/kg SAD
Subjects were orally administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
VBP15
VBP15- 1.0 mg/kg SAD
Subjects were orally administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions.
VBP15
VBP15- 3.0 mg/kg SAD
Subjects were orally administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions.
VBP15
VBP15- 8.0 mg/kg Fasting SAD
Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions.
VBP15
VBP15- 8.0 mg/kg Fed SAD
Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high fat/high high calorie meal.
VBP15
VBP15- 20.0 mg/kg SAD
Subjects were orally administered a single dose of VBP15 at 20.0 mg/kg under fasted conditions.
VBP15
Placebo - SAD
Subjects were orally administered a placebo under fasted conditions.
Placebo
VBP15- 1.0 mg/kg 14 Day MAD
Subjects were orally administered VBP15 at 1.0 mg/kg for 14 days under fasted conditions.
VBP15
VBP15- 3.0 mg/kg 14 Day MAD
Subjects were orally administered VBP15 at 3.0 mg/kg for 14 days under fasted conditions.
VBP15
VBP15- 9.0 mg/kg 14 Day MAD
Subjects were orally administered VBP15 at 9.0 mg/kg for 14 days under fasted conditions.
VBP15
VBP15- 20.0 mg/kg 14 Day MAD
Subjects were orally administered VBP15 at 20.0 mg/kg for 14 days under fasted conditions.
VBP15
Placebo MAD
Subjects were orally administered placebo for 14 days under fasted conditions.
Placebo
Interventions
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VBP15
Placebo
Eligibility Criteria
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Inclusion Criteria
* For the Multiple Ascending Dose Study (MAD): Male subjects or female subjects of nonchildbearing potential ages 18 to 65, inclusive.
Exclusion Criteria
* Clinically significant abnormal laboratory parameters
18 Years
65 Years
ALL
Yes
Sponsors
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ReveraGen BioPharma, Inc.
INDUSTRY
Responsible Party
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Locations
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PRA Health Sciences
Lenexa, Kansas, United States
Countries
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Other Identifiers
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VBP15-001
Identifier Type: -
Identifier Source: org_study_id
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