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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.

Tracking Information
First Submitted Date  ICMJE March 2, 2015
First Posted Date  ICMJE April 14, 2015
Results First Submitted Date  ICMJE June 9, 2016
Results First Posted Date  ICMJE January 5, 2017
Last Update Posted Date March 10, 2017
Study Start Date  ICMJE January 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2017)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 8, 2015)
  • 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 [ 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 [ 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 ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 1 Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of VBP15 in Healthy Adult Subjects
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: VBP15
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: VBP15- 0.1 mg/kg SAD
    Subjects were orally administered a single dose of VBP15 at 0.1 mg/kg under fasted conditions.
    Intervention: 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.
    Intervention: 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.
    Intervention: 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.
    Intervention: 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.
    Intervention: 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.
    Intervention: 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.
    Intervention: Drug: VBP15
  • Placebo Comparator: Placebo - SAD
    Subjects were orally administered a placebo under fasted conditions.
    Intervention: 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.
    Intervention: 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.
    Intervention: 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.
    Intervention: 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.
    Intervention: Drug: VBP15
  • Placebo Comparator: Placebo MAD
    Subjects were orally administered placebo for 14 days under fasted conditions.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 4, 2016)
86
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02415439
Other Study ID Numbers  ICMJE VBP15-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party ReveraGen BioPharma, Inc.
Study Sponsor  ICMJE ReveraGen BioPharma, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account ReveraGen BioPharma, Inc.
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP