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NCT02415439 Clinical Trial

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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02415439
Other study ID # VBP15-001
Secondary ID
Status Recruiting
Phase Phase 1
First received March 2, 2015
Last updated April 8, 2015
Start date January 2015

Study information
Verified date April 2015
Source ReveraGen BioPharma, Inc.
Contact Eric P Hoffman, PhD
Phone 202-476-6011
Email ericphoffman@gmail.com
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 0
Est. completion date
Est. primary completion date December 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- For the SAD component: Male subjects, ages 18 to 65 years, inclusive.

- For the MAD component: Male subjects or female subjects of nonchildbearing potential ages 18 to 65, inclusive.

Exclusion Criteria:

- For the MAD: Women of childbearing potential.

- Clinically significant abnormal laboratory parameters

Study Design

N/A

Related Conditions & MeSH terms

Intervention

Drug:
• VBP15

• Placebo

Locations
Country Name City State
United States PRA Health Sciences Lenexa Kansas

Sponsors (1)
Lead Sponsor Collaborator
ReveraGen BioPharma, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary Area under the plasma concentration versus time curve (AUC) after a single dose of VBP15 Participants will be followed for the duration of hospital stay of 4 days
Primary 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
Primary 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
Primary Area under the plasma concentration versus time curve (AUC) after 14 daily doses of VBP15 Participants will be followed for the duration of hospital stay of 15 days
Primary 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
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