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OpenTrials
Completed

NCT Number: NCT02415439

A Phase 1 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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PRA Health Sciences

Lenexa, Kansas, 66219, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VBP15

Drug

Placebo

Drug

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

ReveraGen BioPharma, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Apr 14, 2015
Registry last updated
Mar 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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