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

NCT02415439 | Completed Phase 1 Results

• 1 other identifier: VBP15-001
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Safety; tolerability; pharmacokinetics; adult; volunteers

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (13)

VBP15- 0.1 mg/kg SAD

EXPERIMENTAL

Subjects were orally administered a single dose of VBP15 at 0.1 mg/kg under fasted conditions.

Drug: VBP15

VBP15- 0.3 mg/kg SAD

EXPERIMENTAL

Subjects were orally administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.

Drug: VBP15

VBP15- 1.0 mg/kg SAD

EXPERIMENTAL

Subjects were orally administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions.

Drug: VBP15

VBP15- 3.0 mg/kg SAD

EXPERIMENTAL

Subjects were orally administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions.

Drug: VBP15

VBP15- 8.0 mg/kg Fasting SAD

EXPERIMENTAL

Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions.

Drug: VBP15

VBP15- 8.0 mg/kg Fed SAD

EXPERIMENTAL

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

VBP15- 20.0 mg/kg SAD

EXPERIMENTAL

Subjects were orally administered a single dose of VBP15 at 20.0 mg/kg under fasted conditions.

Drug: VBP15

Placebo - SAD

PLACEBO COMPARATOR

Subjects were orally administered a placebo under fasted conditions.

Drug: Placebo

VBP15- 1.0 mg/kg 14 Day MAD

EXPERIMENTAL

Subjects were orally administered VBP15 at 1.0 mg/kg for 14 days under fasted conditions.

Drug: VBP15

VBP15- 3.0 mg/kg 14 Day MAD

EXPERIMENTAL

Subjects were orally administered VBP15 at 3.0 mg/kg for 14 days under fasted conditions.

Drug: VBP15

VBP15- 9.0 mg/kg 14 Day MAD

EXPERIMENTAL

Subjects were orally administered VBP15 at 9.0 mg/kg for 14 days under fasted conditions.

Drug: VBP15

VBP15- 20.0 mg/kg 14 Day MAD

EXPERIMENTAL

Subjects were orally administered VBP15 at 20.0 mg/kg for 14 days under fasted conditions.

Drug: VBP15

Placebo MAD

PLACEBO COMPARATOR

Subjects were orally administered placebo for 14 days under fasted conditions.

Drug: Placebo

Interventions

VBP15 DRUG

VBP15- 0.1 mg/kg SAD; VBP15- 0.3 mg/kg SAD; VBP15- 1.0 mg/kg 14 Day MAD; VBP15- 1.0 mg/kg SAD; VBP15- 20.0 mg/kg 14 Day MAD; VBP15- 20.0 mg/kg SAD; VBP15- 3.0 mg/kg 14 Day MAD; VBP15- 3.0 mg/kg SAD; VBP15- 8.0 mg/kg Fasting SAD; VBP15- 8.0 mg/kg Fed SAD; VBP15- 9.0 mg/kg 14 Day MAD

Placebo DRUG

Placebo - SAD; Placebo MAD

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• For the MAD Study: Women of childbearing potential.
• Clinically significant abnormal laboratory parameters

Sponsors & Collaborators

• ReveraGen BioPharma, Inc.: lead

Study Sites (1)

PRA Health Sciences

Lenexa, Kansas, 66219, United States

Location

Results Point of Contact

• Title: Eric P. Hoffman, PhD
• Organization: ReveraGen BioPharma, Inc.

eric.hoffman@reveragen.com

301-962-1578

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2015
• First Posted: April 14, 2015
• Study Start: January 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: May 1, 2016
• Last Updated: March 10, 2017
• Results First Posted: January 5, 2017

Record last verified: 2016-11

Locations

US (1)