Conditions: Healthy
Keywords: Safety tolerability pharmacokinetics adult volunteers
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 86
Healthy volunteers: yes

Brief summary:
The purpose of this study is to examine the safety, tolerability, and PK of various increasing single and multiple doses of VBP15 in healthy adult subjects.

Detailed description:

Arms:
arm 1: Subjects were orally administered a single dose of VBP15 at 0.1 mg/kg under fasted conditions. arm 2: Subjects were orally administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions. arm 3: Subjects were orally administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions. arm 4: Subjects were orally administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions. arm 5: Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions. arm 6: 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. arm 7: Subjects were orally administered a single dose of VBP15 at 20.0 mg/kg under fasted conditions. arm 8: Subjects were orally administered a placebo under fasted conditions. arm 9: Subjects were orally administered VBP15 at 1.0 mg/kg for 14 days under fasted conditions. arm 10: Subjects were orally administered VBP15 at 3.0 mg/kg for 14 days under fasted conditions. arm 11: Subjects were orally administered VBP15 at 9.0 mg/kg for 14 days under fasted conditions. arm 12: Subjects were orally administered VBP15 at 20.0 mg/kg for 14 days under fasted conditions. arm 13: Subjects were orally administered placebo for 14 days under fasted conditions.

Interventions: intervention 1: VBP15 intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: