Phase 1
Completed N=86
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
Source: ClinicalTrials.gov NCT02415439 ↗
Enrolled (actual)
86
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcomePrimary: Number of Subjects With Adverse Effects After a Single Dose of VBP15 — 2; 1; 1; 1 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Adverse Effects After a Single Dose of VBP15 |
2; 1; 1; 1; 0; 1 | — |
| PRIMARY Area Under the Plasma Concentration Versus Time Curve (AUC) After a Single Dose of VBP15 (0 Through 72 Hours Post Dose) |
42; 161; 486; 1578; 3997; 10139 | — |
| PRIMARY Peak Plasma Concentration (Cmax) of VBP15 After a Single Dose of VBP15 |
13; 51; 122; 305; 718; 1817 | — |
| PRIMARY Number of Subjects With Adverse Effects After 14 Daily Doses of VBP15 |
2; 0; 0; 2; 2 | — |
| PRIMARY Area Under the Plasma Concentration Versus Time Curve (AUC) After 14 Daily Doses of VBP15 (0 Through 72 Hours Post Dose) |
794; 1494; 4366; 9309; 0 | — |
| PRIMARY Peak Plasma Concentration (Cmax) of VBP15 After 14 Daily Doses of VBP15 |
153; 281; 1082; 2416; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02415439). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.