A Phase 1 Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of VBP15 in Healthy Adult Subjects

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: VBP15

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • PRA Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

13

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: ReveraGen BioPharma, Inc.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: March 2, 2015
• First Submitted That Met QC Criteria: April 8, 2015
• First Posted (Estimate): April 14, 2015

Study Record Updates

• Last Update Posted (Actual): March 10, 2017
• Last Update Submitted That Met QC Criteria: January 30, 2017
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Safety; adult; tolerability; pharmacokinetics; volunteers
• Other Study ID Numbers: VBP15-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No