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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
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
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
Experimental: VBP15- 0.1 mg/kg SAD
Subjects were orally administered a single dose of VBP15 at 0.1 mg/kg under fasted conditions.
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.
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.
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.
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.
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.
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.
Drug: VBP15
Placebo Comparator: Placebo - SAD
Subjects were orally administered a placebo under fasted conditions.
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.
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.
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.
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.
Drug: VBP15
Placebo Comparator: Placebo MAD
Subjects were orally administered placebo for 14 days under fasted conditions.
Drug: Placebo



Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Locations
United States, Kansas
PRA Health Sciences
Lenexa, Kansas, United States, 66219
Sponsors and Collaborators
ReveraGen BioPharma, Inc.

Responsible Party: ReveraGen BioPharma, Inc.
ClinicalTrials.gov Identifier: NCT02415439     History of Changes
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

Keywords provided by ReveraGen BioPharma, Inc.:
Safety
tolerability
pharmacokinetics
adult
volunteers