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

Reveragen BioPharma

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: VBP15

Study type: Interventional

Funder types: Industry

Identifiers

NCT02415439

VBP15-001

Details and patient eligibility

About

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.

Enrollment: 86 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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86 participants in 13 patient groups, including a placebo group

VBP15- 0.1 mg/kg SAD

Experimental group

Description:

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

Treatment:

Drug: VBP15

VBP15- 0.3 mg/kg SAD

Experimental group

Description:

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

Treatment:

Drug: VBP15

VBP15- 1.0 mg/kg SAD

Experimental group

Description:

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

Treatment:

Drug: VBP15

VBP15- 3.0 mg/kg SAD

Experimental group

Description:

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

Treatment:

Drug: VBP15

VBP15- 8.0 mg/kg Fasting SAD

Experimental group

Description:

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

Treatment:

Drug: VBP15

VBP15- 8.0 mg/kg Fed SAD

Experimental group

Description:

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.

Treatment:

Drug: VBP15

VBP15- 20.0 mg/kg SAD

Experimental group

Description:

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

Treatment:

Drug: VBP15

Placebo - SAD

Placebo Comparator group

Description:

Subjects were orally administered a placebo under fasted conditions.

Treatment:

Drug: Placebo

VBP15- 1.0 mg/kg 14 Day MAD

Experimental group

Description:

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

Treatment:

Drug: VBP15

VBP15- 3.0 mg/kg 14 Day MAD

Experimental group

Description:

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

Treatment:

Drug: VBP15

VBP15- 9.0 mg/kg 14 Day MAD

Experimental group

Description:

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

Treatment:

Drug: VBP15

VBP15- 20.0 mg/kg 14 Day MAD

Experimental group

Description:

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

Treatment:

Drug: VBP15

Placebo MAD

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo