A Phase 1 Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of VBP15 in Healthy Adult Subjects
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ClinicalTrials.gov Identifier: NCT02415439 |
Recruitment Status :
Completed
First Posted : April 14, 2015
Results First Posted : January 5, 2017
Last Update Posted : March 10, 2017
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Condition or disease | Intervention/treatment | Phase |
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Healthy | Drug: VBP15 Drug: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 86 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1 Randomized, Placebo-Controlled, Double-Blind, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of VBP15 in Healthy Adult Subjects |
Study Start Date : | January 2015 |
Actual Primary Completion Date : | November 2015 |
Actual Study Completion Date : | May 2016 |
Arm | Intervention/treatment |
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Experimental: VBP15- 0.1 mg/kg SAD
Subjects were orally administered a single dose of VBP15 at 0.1 mg/kg under fasted conditions.
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Drug: VBP15 |
Experimental: VBP15- 0.3 mg/kg SAD
Subjects were orally administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
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Drug: VBP15 |
Experimental: VBP15- 1.0 mg/kg SAD
Subjects were orally administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions.
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Drug: VBP15 |
Experimental: VBP15- 3.0 mg/kg SAD
Subjects were orally administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions.
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Drug: VBP15 |
Experimental: VBP15- 8.0 mg/kg Fasting SAD
Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions.
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Drug: VBP15 |
Experimental: 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.
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Drug: VBP15 |
Experimental: VBP15- 20.0 mg/kg SAD
Subjects were orally administered a single dose of VBP15 at 20.0 mg/kg under fasted conditions.
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Drug: VBP15 |
Placebo Comparator: Placebo - SAD
Subjects were orally administered a placebo under fasted conditions.
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Drug: Placebo |
Experimental: VBP15- 1.0 mg/kg 14 Day MAD
Subjects were orally administered VBP15 at 1.0 mg/kg for 14 days under fasted conditions.
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Drug: VBP15 |
Experimental: VBP15- 3.0 mg/kg 14 Day MAD
Subjects were orally administered VBP15 at 3.0 mg/kg for 14 days under fasted conditions.
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Drug: VBP15 |
Experimental: VBP15- 9.0 mg/kg 14 Day MAD
Subjects were orally administered VBP15 at 9.0 mg/kg for 14 days under fasted conditions.
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Drug: VBP15 |
Experimental: VBP15- 20.0 mg/kg 14 Day MAD
Subjects were orally administered VBP15 at 20.0 mg/kg for 14 days under fasted conditions.
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Drug: VBP15 |
Placebo Comparator: Placebo MAD
Subjects were orally administered placebo for 14 days under fasted conditions.
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Drug: Placebo |
- Number of Subjects With Adverse Effects After a Single Dose of VBP15 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: Participants will be followed for the duration of hospital stay of 15 days ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02415439
United States, Kansas | |
PRA Health Sciences | |
Lenexa, Kansas, United States, 66219 |
Responsible Party: | ReveraGen BioPharma, Inc. |
ClinicalTrials.gov Identifier: | NCT02415439 |
Other Study ID Numbers: |
VBP15-001 |
First Posted: | April 14, 2015 Key Record Dates |
Results First Posted: | January 5, 2017 |
Last Update Posted: | March 10, 2017 |
Last Verified: | November 2016 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Safety tolerability pharmacokinetics adult volunteers |