Healthy
Conditions
Keywords
Safety, tolerability, pharmacokinetics, adult, volunteers
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.
Interventions
DRUGVBP15
DRUGPlacebo
Sponsors
ReveraGen BioPharma, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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 |
Countries
United States
Participant flow
Recruitment details
In the single ascending dose (SAD) study, subjects were assigned to 1 of 7 dose groups and received a single oral dose of VBP15 or placebo. The multiple ascending dose (MAD) was initiated after a review of safety data from SAD groups. In the MAD study, subjects were randomized to 1 of 4 groups to receive VBP15 or placebo once daily for 14 days
Pre-assignment details
An escalating-dose design was chosen for the SAD and MAD studies to allow increase of the dose after assessment of safety and tolerability of each preceding dose. Escalation to the next higher dose was performed using a factor of 3 for each subsequent dose until a maximum of 20 mg/kg was reached. No subject received more than 1 dose level of VBP15.
Participants by arm
| Arm | Count |
|---|---|
| VBP15- 0.1 mg/kg SAD Subjects were orally administered a single dose of VBP15 at 0.1 mg/kg under fasted conditions | 6 |
| VBP15- 0.3 mg/kg SAD Subjects were orally administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions | 6 |
| VBP15- 1.0 mg/kg SAD Subjects were orally administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions | 6 |
| VBP15- 3.0 mg/kg SAD Subjects were orally administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions | 6 |
| VBP15- 8.0 mg/kg Fasted SAD Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions | 6 |
| VBP15- 8.0 mg/kg Fed SAD Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high fat/high calorie meal | 6 |
| VBP15- 20.0 mg/kg SAD Subjects were orally administered a single dose of VBP15 at 20.0 mg/kg under fasted conditions | 6 |
| Placebo SAD Subjects were orally administered a single dose of placebo under fasted conditions | 12 |
| VBP15- 1.0 mg/kg 14 Days MAD Subjects were orally administered VBP15 at 1.0 mg/kg daily for 14 days under fasted conditions | 6 |
| VBP15 - 3.0 mg/kg 14 Days MAD Subjects were orally administered VBP15 at 3.0 mg/kg daily for 14 days under fasted conditions | 6 |
| VBP15- 9.0 mg/kg 14 Days MAD Subjects were orally administered VBP15 at 9.0 mg/kg daily for 14 days under fasted conditions | 6 |
| VBP15- 20.0 mg/kg 14 Days MAD Subjects were orally administered VBP15 at 20.0 mg/kg daily for 14 days under fasted conditions | 6 |
| Placebo MAD Subjects were orally administered placebo daily for 14 days under fasted conditions | 8 |
| Total | 86 |
Baseline characteristics
| Characteristic | VBP15- 0.1 mg/kg SAD | VBP15- 0.3 mg/kg SAD | VBP15- 1.0 mg/kg SAD | VBP15- 3.0 mg/kg SAD | VBP15- 8.0 mg/kg Fasted SAD | VBP15- 8.0 mg/kg Fed SAD | VBP15- 20.0 mg/kg SAD | Placebo SAD | VBP15- 1.0 mg/kg 14 Days MAD | VBP15 - 3.0 mg/kg 14 Days MAD | VBP15- 9.0 mg/kg 14 Days MAD | VBP15- 20.0 mg/kg 14 Days MAD | Placebo MAD | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 12 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 8 Participants | 86 Participants |
| Region of Enrollment United States | 6 participants | 6 participants | 6 participants | 6 participants | 6 participants | 6 participants | 6 participants | 12 participants | 6 participants | 6 participants | 6 participants | 6 participants | 8 participants | 86 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 12 Participants | 6 Participants | 6 Participants | 6 Participants | 6 Participants | 8 Participants | 86 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 6 | 1 / 6 | 1 / 6 | 1 / 6 | 0 / 6 | 1 / 6 | 0 / 6 | 0 / 12 | 2 / 6 | 0 / 6 | 0 / 6 | 2 / 6 | 2 / 8 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 12 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 8 |
Outcome results
Primary
Area Under the Plasma Concentration Versus Time Curve (AUC) After 14 Daily Doses of VBP15 (0 Through 72 Hours Post Dose)
Time frame: Participants will be followed for the duration of hospital stay of 15 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VBP15- 0.1 mg/kg SAD | Area Under the Plasma Concentration Versus Time Curve (AUC) After 14 Daily Doses of VBP15 (0 Through 72 Hours Post Dose) | 794 (hr*ng/mL) | Standard Deviation 22 |
| VBP15- 0.3 mg/kg SAD | Area Under the Plasma Concentration Versus Time Curve (AUC) After 14 Daily Doses of VBP15 (0 Through 72 Hours Post Dose) | 1494 (hr*ng/mL) | Standard Deviation 19 |
| VBP15- 1.0 mg/kg SAD | Area Under the Plasma Concentration Versus Time Curve (AUC) After 14 Daily Doses of VBP15 (0 Through 72 Hours Post Dose) | 4366 (hr*ng/mL) | Standard Deviation 20 |
| VBP15- 3.0 mg/kg SAD | Area Under the Plasma Concentration Versus Time Curve (AUC) After 14 Daily Doses of VBP15 (0 Through 72 Hours Post Dose) | 9309 (hr*ng/mL) | Standard Deviation 39 |
| VBP15- 8.0 mg/kg Fasting SAD | Area Under the Plasma Concentration Versus Time Curve (AUC) After 14 Daily Doses of VBP15 (0 Through 72 Hours Post Dose) | 0 (hr*ng/mL) | Standard Deviation 0 |
Primary
Area Under the Plasma Concentration Versus Time Curve (AUC) After a Single Dose of VBP15 (0 Through 72 Hours Post Dose)
Time frame: Participants will be followed for the duration of hospital stay of 4 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VBP15- 0.1 mg/kg SAD | Area Under the Plasma Concentration Versus Time Curve (AUC) After a Single Dose of VBP15 (0 Through 72 Hours Post Dose) | 42 (hr*ng/mL) | Standard Deviation 17 |
| VBP15- 0.3 mg/kg SAD | Area Under the Plasma Concentration Versus Time Curve (AUC) After a Single Dose of VBP15 (0 Through 72 Hours Post Dose) | 161 (hr*ng/mL) | Standard Deviation 16 |
| VBP15- 1.0 mg/kg SAD | Area Under the Plasma Concentration Versus Time Curve (AUC) After a Single Dose of VBP15 (0 Through 72 Hours Post Dose) | 486 (hr*ng/mL) | Standard Deviation 20 |
| VBP15- 3.0 mg/kg SAD | Area Under the Plasma Concentration Versus Time Curve (AUC) After a Single Dose of VBP15 (0 Through 72 Hours Post Dose) | 1578 (hr*ng/mL) | Standard Deviation 21 |
| VBP15- 8.0 mg/kg Fasting SAD | Area Under the Plasma Concentration Versus Time Curve (AUC) After a Single Dose of VBP15 (0 Through 72 Hours Post Dose) | 3997 (hr*ng/mL) | Standard Deviation 55 |
| VBP15- 8.0 mg/kg Fed SAD | Area Under the Plasma Concentration Versus Time Curve (AUC) After a Single Dose of VBP15 (0 Through 72 Hours Post Dose) | 10139 (hr*ng/mL) | Standard Deviation 25 |
| VBP15- 20.0 mg/kg SAD | Area Under the Plasma Concentration Versus Time Curve (AUC) After a Single Dose of VBP15 (0 Through 72 Hours Post Dose) | 8545 (hr*ng/mL) | Standard Deviation 30 |
| Placebo SAD | Area Under the Plasma Concentration Versus Time Curve (AUC) After a Single Dose of VBP15 (0 Through 72 Hours Post Dose) | 0 (hr*ng/mL) | Standard Deviation 0 |
Primary
Number of Subjects With Adverse Effects After 14 Daily Doses of VBP15
Time frame: Participants will be followed for the duration of hospital stay of 15 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VBP15- 0.1 mg/kg SAD | Number of Subjects With Adverse Effects After 14 Daily Doses of VBP15 | 2 participants |
| VBP15- 0.3 mg/kg SAD | Number of Subjects With Adverse Effects After 14 Daily Doses of VBP15 | 0 participants |
| VBP15- 1.0 mg/kg SAD | Number of Subjects With Adverse Effects After 14 Daily Doses of VBP15 | 0 participants |
| VBP15- 3.0 mg/kg SAD | Number of Subjects With Adverse Effects After 14 Daily Doses of VBP15 | 2 participants |
| VBP15- 8.0 mg/kg Fasting SAD | Number of Subjects With Adverse Effects After 14 Daily Doses of VBP15 | 2 participants |
Primary
Number of Subjects With Adverse Effects After a Single Dose of VBP15
Time frame: Participants will be followed for the duration of hospital stay of 4 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VBP15- 0.1 mg/kg SAD | Number of Subjects With Adverse Effects After a Single Dose of VBP15 | 2 participants |
| VBP15- 0.3 mg/kg SAD | Number of Subjects With Adverse Effects After a Single Dose of VBP15 | 1 participants |
| VBP15- 1.0 mg/kg SAD | Number of Subjects With Adverse Effects After a Single Dose of VBP15 | 1 participants |
| VBP15- 3.0 mg/kg SAD | Number of Subjects With Adverse Effects After a Single Dose of VBP15 | 1 participants |
| VBP15- 8.0 mg/kg Fasting SAD | Number of Subjects With Adverse Effects After a Single Dose of VBP15 | 0 participants |
| VBP15- 8.0 mg/kg Fed SAD | Number of Subjects With Adverse Effects After a Single Dose of VBP15 | 1 participants |
| VBP15- 20.0 mg/kg SAD | Number of Subjects With Adverse Effects After a Single Dose of VBP15 | 0 participants |
| Placebo SAD | Number of Subjects With Adverse Effects After a Single Dose of VBP15 | 0 participants |
Primary
Peak Plasma Concentration (Cmax) of VBP15 After 14 Daily Doses of VBP15
Time frame: Participants will be followed for the duration of hospital stay of 15 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VBP15- 0.1 mg/kg SAD | Peak Plasma Concentration (Cmax) of VBP15 After 14 Daily Doses of VBP15 | 153 (ng/mL) | Standard Deviation 16 |
| VBP15- 0.3 mg/kg SAD | Peak Plasma Concentration (Cmax) of VBP15 After 14 Daily Doses of VBP15 | 281 (ng/mL) | Standard Deviation 37 |
| VBP15- 1.0 mg/kg SAD | Peak Plasma Concentration (Cmax) of VBP15 After 14 Daily Doses of VBP15 | 1082 (ng/mL) | Standard Deviation 23 |
| VBP15- 3.0 mg/kg SAD | Peak Plasma Concentration (Cmax) of VBP15 After 14 Daily Doses of VBP15 | 2416 (ng/mL) | Standard Deviation 51 |
| VBP15- 8.0 mg/kg Fasting SAD | Peak Plasma Concentration (Cmax) of VBP15 After 14 Daily Doses of VBP15 | 0 (ng/mL) | Standard Deviation 0 |
Primary
Peak Plasma Concentration (Cmax) of VBP15 After a Single Dose of VBP15
Time frame: Participants will be followed for the duration of hospital stay of 4 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| VBP15- 0.1 mg/kg SAD | Peak Plasma Concentration (Cmax) of VBP15 After a Single Dose of VBP15 | 13 (ng/mL) | Standard Deviation 13 |
| VBP15- 0.3 mg/kg SAD | Peak Plasma Concentration (Cmax) of VBP15 After a Single Dose of VBP15 | 51 (ng/mL) | Standard Deviation 17 |
| VBP15- 1.0 mg/kg SAD | Peak Plasma Concentration (Cmax) of VBP15 After a Single Dose of VBP15 | 122 (ng/mL) | Standard Deviation 33 |
| VBP15- 3.0 mg/kg SAD | Peak Plasma Concentration (Cmax) of VBP15 After a Single Dose of VBP15 | 305 (ng/mL) | Standard Deviation 24 |
| VBP15- 8.0 mg/kg Fasting SAD | Peak Plasma Concentration (Cmax) of VBP15 After a Single Dose of VBP15 | 718 (ng/mL) | Standard Deviation 43 |
| VBP15- 8.0 mg/kg Fed SAD | Peak Plasma Concentration (Cmax) of VBP15 After a Single Dose of VBP15 | 1817 (ng/mL) | Standard Deviation 31 |
| VBP15- 20.0 mg/kg SAD | Peak Plasma Concentration (Cmax) of VBP15 After a Single Dose of VBP15 | 1648 (ng/mL) | Standard Deviation 17 |
| Placebo SAD | Peak Plasma Concentration (Cmax) of VBP15 After a Single Dose of VBP15 | 0 (ng/mL) | Standard Deviation 0 |