A Phase 1 Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of VBP15 in Healthy Adult Subjects
- Registration Number
- NCT02415439
- Lead Sponsor
- ReveraGen BioPharma, Inc.
- 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
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 86
Inclusion Criteria
- For the Single Ascending Dose Study (SAD): Male subjects, ages 18 to 65 years, inclusive.
- For the Multiple Ascending Dose Study (MAD): Male subjects or female subjects of nonchildbearing potential ages 18 to 65, inclusive.
Exclusion Criteria
- For the MAD Study: Women of childbearing potential.
- Clinically significant abnormal laboratory parameters
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description VBP15- 0.1 mg/kg SAD VBP15 Subjects were orally administered a single dose of VBP15 at 0.1 mg/kg under fasted conditions. VBP15- 1.0 mg/kg SAD VBP15 Subjects were orally administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions. VBP15- 3.0 mg/kg SAD VBP15 Subjects were orally administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions. VBP15- 20.0 mg/kg 14 Day MAD VBP15 Subjects were orally administered VBP15 at 20.0 mg/kg for 14 days under fasted conditions. Placebo MAD Placebo Subjects were orally administered placebo for 14 days under fasted conditions. VBP15- 8.0 mg/kg Fasting SAD VBP15 Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions. VBP15- 1.0 mg/kg 14 Day MAD VBP15 Subjects were orally administered VBP15 at 1.0 mg/kg for 14 days under fasted conditions. VBP15- 3.0 mg/kg 14 Day MAD VBP15 Subjects were orally administered VBP15 at 3.0 mg/kg for 14 days under fasted conditions. VBP15- 8.0 mg/kg Fed SAD VBP15 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- 20.0 mg/kg SAD VBP15 Subjects were orally administered a single dose of VBP15 at 20.0 mg/kg under fasted conditions. VBP15- 9.0 mg/kg 14 Day MAD VBP15 Subjects were orally administered VBP15 at 9.0 mg/kg for 14 days under fasted conditions. Placebo - SAD Placebo Subjects were orally administered a placebo under fasted conditions. VBP15- 0.3 mg/kg SAD VBP15 Subjects were orally administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
- Primary Outcome Measures
Name Time Method Number of Subjects With Adverse Effects After a Single Dose of VBP15 Participants will be followed for the duration of hospital stay of 4 days Area Under the Plasma Concentration Versus Time Curve (AUC) After a Single Dose of VBP15 (0 Through 72 Hours Post Dose) Participants will be followed for the duration of hospital stay of 4 days Peak Plasma Concentration (Cmax) of VBP15 After a Single Dose of VBP15 Participants will be followed for the duration of hospital stay of 4 days Number of Subjects With Adverse Effects After 14 Daily Doses of VBP15 Participants will be followed for the duration of hospital stay of 15 days Area Under the Plasma Concentration Versus Time Curve (AUC) After 14 Daily Doses of VBP15 (0 Through 72 Hours Post Dose) Participants will be followed for the duration of hospital stay of 15 days Peak Plasma Concentration (Cmax) of VBP15 After 14 Daily Doses of VBP15 Participants will be followed for the duration of hospital stay of 15 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
PRA Health Sciences
🇺🇸Lenexa, Kansas, United States