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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: VBP15
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VBP15- 0.1 mg/kg SAD<br>Subjects were orally administered a single dose of VBP15 at 0.1 mg/kg under fasted conditions. | Drug: VBP15<br> <br> |
| Experimental: VBP15- 0.3 mg/kg SAD<br>Subjects were orally administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions. | Drug: VBP15<br> <br> |
| Experimental: VBP15- 1.0 mg/kg SAD<br>Subjects were orally administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions. | Drug: VBP15<br> <br> |
| Experimental: VBP15- 3.0 mg/kg SAD<br>Subjects were orally administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions. | Drug: VBP15<br> <br> |
| Experimental: VBP15- 8.0 mg/kg Fasting SAD<br>Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions. | Drug: VBP15<br> <br> |
| Experimental: VBP15- 8.0 mg/kg Fed SAD<br>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<br> <br> |
| Experimental: VBP15- 20.0 mg/kg SAD<br>Subjects were orally administered a single dose of VBP15 at 20.0 mg/kg under fasted conditions. | Drug: VBP15<br> <br> |
| Placebo Comparator: Placebo - SAD<br>Subjects were orally administered a placebo under fasted conditions. | Drug: Placebo<br> <br> |
| Experimental: VBP15- 1.0 mg/kg 14 Day MAD<br>Subjects were orally administered VBP15 at 1.0 mg/kg for 14 days under fasted conditions. | Drug: VBP15<br> <br> |
| Experimental: VBP15- 3.0 mg/kg 14 Day MAD<br>Subjects were orally administered VBP15 at 3.0 mg/kg for 14 days under fasted conditions. | Drug: VBP15<br> <br> |
| Experimental: VBP15- 9.0 mg/kg 14 Day MAD<br>Subjects were orally administered VBP15 at 9.0 mg/kg for 14 days under fasted conditions. | Drug: VBP15<br> <br> |
| Experimental: VBP15- 20.0 mg/kg 14 Day MAD<br>Subjects were orally administered VBP15 at 20.0 mg/kg for 14 days under fasted conditions. | Drug: VBP15<br> <br> |
| Placebo Comparator: Placebo MAD<br>Subjects were orally administered placebo for 14 days under fasted conditions. | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety, tolerability, pharmacokinetics, adult, volunteers