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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VBP15- 0.1 mg/kg SAD | Experimental | Subjects were orally administered a single dose of VBP15 at 0.1 mg/kg under fasted conditions. |
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| VBP15- 0.3 mg/kg SAD | Experimental | Subjects were orally administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions. |
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| VBP15- 1.0 mg/kg SAD | Experimental | Subjects were orally administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions. |
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| VBP15- 3.0 mg/kg SAD | Experimental | Subjects were orally administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions. |
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| 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. |
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| VBP15- 8.0 mg/kg Fed SAD | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VBP15 | Drug |
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| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA Health Sciences | Lenexa | Kansas | 66219 | United States |
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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.
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
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| ID | Title | Description |
|---|---|---|
| FG000 | VBP15- 0.1 mg/kg SAD | Subjects were orally administered a single dose of VBP15 at 0.1 mg/kg under fasted conditions. |
| FG001 | VBP15- 0.3 mg/kg SAD | Subjects were orally administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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. |
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| VBP15- 20.0 mg/kg SAD | Experimental | Subjects were orally administered a single dose of VBP15 at 20.0 mg/kg under fasted conditions. |
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| Placebo - SAD | Placebo Comparator | Subjects were orally administered a placebo under fasted conditions. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| Placebo MAD | Placebo Comparator | Subjects were orally administered placebo for 14 days under fasted conditions. |
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| Placebo | Drug |
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| FG002 | VBP15- 1.0 mg/kg SAD | Subjects were orally administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions. |
| FG003 | VBP15- 3.0 mg/kg SAD | Subjects were orally administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions. |
| FG004 | VBP15- 8.0 mg/kg Fasted SAD | Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions. |
| FG005 | 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. |
| FG006 | VBP15- 20.0 mg/kg SAD | Subjects were orally administered a single dose of VBP15 at 20.0 mg/kg under fasted conditions. |
| FG007 | Placebo SAD | Subjects were orally administered a single dose of placebo under fasted conditions. |
| FG008 | VBP15- 1.0 mg/kg 14 Day MAD | Subjects were orally administered VBP15 at 1.0 mg/kg daily for 14 days under fasted conditions. |
| FG009 | VBP15- 3.0 mg/kg 14 Day MAD | Subjects were orally administered VBP15 at 3.0 mg/kg daily for 14 days under fasted conditions. |
| FG010 | VBP15- 9.0 mg/kg 14 Day MAD | Subjects were orally administered VBP15 at 9.0 mg/kg daily for 14 days under fasted conditions. |
| FG011 | VBP15- 20 mg/kg 14 Day MAD | Subjects were orally administered VBP15 at 20.0 mg/kg daily for 14 days under fasted conditions. |
| FG012 | Placebo MAD | Subjects were orally administered placebo daily for 14 days under fasted conditions. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | VBP15- 0.1 mg/kg SAD | Subjects were orally administered a single dose of VBP15 at 0.1 mg/kg under fasted conditions |
| BG001 | VBP15- 0.3 mg/kg SAD | Subjects were orally administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions |
| BG002 | VBP15- 1.0 mg/kg SAD | Subjects were orally administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions |
| BG003 | VBP15- 3.0 mg/kg SAD | Subjects were orally administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions |
| BG004 | VBP15- 8.0 mg/kg Fasted SAD | Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions |
| BG005 | 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 |
| BG006 | VBP15- 20.0 mg/kg SAD | Subjects were orally administered a single dose of VBP15 at 20.0 mg/kg under fasted conditions |
| BG007 | Placebo SAD | Subjects were orally administered a single dose of placebo under fasted conditions |
| BG008 | 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 |
| BG009 | 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 |
| BG010 | 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 |
| BG011 | 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 |
| BG012 | Placebo MAD | Subjects were orally administered placebo daily for 14 days under fasted conditions |
| BG013 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With Adverse Effects After a Single Dose of VBP15 | Posted | Number | participants | Participants will be followed for the duration of hospital stay of 4 days |
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| Primary | Area Under the Plasma Concentration Versus Time Curve (AUC) After a Single Dose of VBP15 (0 Through 72 Hours Post Dose) | Posted | Mean | Standard Deviation | (hr*ng/mL) | Participants will be followed for the duration of hospital stay of 4 days |
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| Primary | Peak Plasma Concentration (Cmax) of VBP15 After a Single Dose of VBP15 | Posted | Mean | Standard Deviation | (ng/mL) | Participants will be followed for the duration of hospital stay of 4 days |
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| Primary | Number of Subjects With Adverse Effects After 14 Daily Doses of VBP15 | Posted | Number | participants | Participants will be followed for the duration of hospital stay of 15 days |
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| Primary | Area Under the Plasma Concentration Versus Time Curve (AUC) After 14 Daily Doses of VBP15 (0 Through 72 Hours Post Dose) | Posted | Mean | Standard Deviation | (hr*ng/mL) | Participants will be followed for the duration of hospital stay of 15 days |
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| Primary | Peak Plasma Concentration (Cmax) of VBP15 After 14 Daily Doses of VBP15 | Posted | Mean | Standard Deviation | (ng/mL) | Participants will be followed for the duration of hospital stay of 15 days |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VBP15- 0.1 mg/kg SAD | Subjects were orally administered a single dose of VBP15 at 0.1 mg/kg under fasted conditions. | 0 | 6 | 2 | 6 | ||
| EG001 | VBP15- 0.3 mg/kg SAD | Subjects were orally administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions. | 0 | 6 | 1 | 6 | ||
| EG002 | VBP15- 1.0 mg/kg SAD | Subjects were orally administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions. | 0 | 6 | 1 | 6 | ||
| EG003 | VBP15- 3.0 mg/kg SAD | Subjects were orally administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions. | 0 | 6 | 1 | 6 | ||
| EG004 | VBP15- 8.0 mg/kg Fasted SAD | Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions. | 0 | 6 | 0 | 6 | ||
| EG005 | 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. | 0 | 6 | 1 | 6 | ||
| EG006 | VBP15- 20.0 mg/kg SAD | Subjects were orally administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions. | 0 | 6 | 0 | 6 | ||
| EG007 | Placebo SAD | Subjects were orally administered a single dose of placebo under fasted conditions. | 0 | 12 | 0 | 12 | ||
| EG008 | VBP15- 1.0 mg/kg 14 Days MAD | Subjects were orally administered a dose of VBP15 at 1.0 mg/kg daily for 14 days under fasted conditions. | 0 | 6 | 2 | 6 | ||
| EG009 | VBP15- 3.0 mg/kg 14 Days MAD | Subjects were orally administered a dose of VBP15 at 3.0 mg/kg daily for 14 days under fasted conditions. | 0 | 6 | 0 | 6 | ||
| EG010 | VBP15- 9.0 mg/kg 14 Days MAD | Subjects were orally administered a dose of VBP15 at 9.0 mg/kg daily for 14 days under fasted conditions. | 0 | 6 | 0 | 6 | ||
| EG011 | VBP15- 20.0 mg/kg 14 Days MAD | Subjects were orally administered a dose of VBP15 at 20.0 mg/kg daily for 14 days under fasted conditions. | 0 | 6 | 2 | 6 | ||
| EG012 | Placebo MAD | Subjects were orally administered a dose of placebo daily for 14 days under fasted conditions. | 0 | 8 | 2 | 8 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders |
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| Ear Pain, Left | Ear and labyrinth disorders |
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| Dizziness | Nervous system disorders |
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| Nausea | Gastrointestinal disorders |
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| Non-cardiac chest pain | General disorders |
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| Blood bilirubin, increased | Investigations |
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| Pain extremity left elbow | Musculoskeletal and connective tissue disorders | Arthralgia |
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| Syncope | Nervous system disorders |
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| Elevated liver enzymes | Investigations |
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| Worsening of toothache-right upper molar | Gastrointestinal disorders | Toothache |
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| Vomiting | Gastrointestinal disorders |
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| Elevated liver enzyme: ALT | Investigations |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eric P. Hoffman, PhD | ReveraGen BioPharma, Inc. | 301-962-1578 | eric.hoffman@reveragen.com |
| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| OG005 | VBP15- 8.0 mg/kg Fed SAD | Subjects were administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high-fat/high calorie meal. |
| OG006 | VBP15- 20.0 mg/kg SAD | Subjects were administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions. |
| OG007 | Placebo SAD | Subjects were administered a single dose of placebo under fasted conditions. |
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| OG005 | VBP15- 8.0 mg/kg Fed SAD | Subjects were administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high-fat/high calorie meal. |
| OG006 | VBP15- 20.0 mg/kg SAD | Subjects were administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions. |
| OG007 | Placebo SAD | Subjects were administered a single dose of placebo under fasted conditions. |
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Subjects were orally admistered placebo daily for 14 days under fasted conditions.
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