Trial Outcomes & Findings for Safety, Tolerability, Pharmacokinetic Characteristics of hzVSF-v13 in Healthy Male Volunteers (NCT NCT03653208)
NCT ID: NCT03653208
Last Updated: 2021-04-27
Results Overview
Systolic Blood Pressure: ≤ 90 mmHg and decrease from baseline ≥ 20 mmHg, ≥ 140 mmHg and increase from baseline ≥ 20 mmHg Diastolic Blood Pressure: ≤ 50 mmHg and decrease from baseline ≥ 10 mmHg, ≥ 90 mmHg and increase from baseline ≥ 10 mmHg Heart Rate: ≤ 40 beats/min and decrease from baseline ≥ 20 beats/min, ≥ 100 beats/min and increase from baseline ≥ 20 beats/min
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
56 participants
Primary outcome timeframe
0 (pre-dose), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1176, 1512, 1848, 2184 hours (post-dose)
Results posted on
2021-04-27
Participant Flow
Participant milestones
| Measure |
Group 1 (hzVSF-v13 10mg)
Group 1 received a single 10mg dose of hzVSF-v13 on Day 1.
|
Group 2 (hzVSF-v13 20mg)
Group 2 received a single 20mg dose of hzVSF-v13 on Day 1.
|
Group 3 (hzVSF-v13 50mg)
Group 3 received a single 50mg dose of hzVSF-v13 on Day 1.
|
Group 4 (hzVSF-v13 100mg)
Group 4 received a single 100mg dose of hzVSF-v13 on Day 1.
|
Group 5 (hzVSF-v13 200mg)
Group 5 received a single 200mg dose of hzVSF-v13 on Day 1.
|
Group 6 (hzVSF-v13 400mg)
Group 6 received a single 400mg dose of hzVSF-v13 on Day 1.
|
Group 7 (hzVSF-v13 800mg)
Group 7 received a single 800mg dose of hzVSF-v13 on Day 1.
|
Group 8 (hzVSF-v13 1200mg)
Group 8 received a single 1200mg dose of hzVSF-v13 on Day 1.
|
Placebo
Placebo group received a single placebo on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
6
|
6
|
6
|
6
|
6
|
6
|
14
|
|
Overall Study
COMPLETED
|
3
|
3
|
6
|
6
|
5
|
6
|
6
|
5
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Group 1 (hzVSF-v13 10mg)
Group 1 received a single 10mg dose of hzVSF-v13 on Day 1.
|
Group 2 (hzVSF-v13 20mg)
Group 2 received a single 20mg dose of hzVSF-v13 on Day 1.
|
Group 3 (hzVSF-v13 50mg)
Group 3 received a single 50mg dose of hzVSF-v13 on Day 1.
|
Group 4 (hzVSF-v13 100mg)
Group 4 received a single 100mg dose of hzVSF-v13 on Day 1.
|
Group 5 (hzVSF-v13 200mg)
Group 5 received a single 200mg dose of hzVSF-v13 on Day 1.
|
Group 6 (hzVSF-v13 400mg)
Group 6 received a single 400mg dose of hzVSF-v13 on Day 1.
|
Group 7 (hzVSF-v13 800mg)
Group 7 received a single 800mg dose of hzVSF-v13 on Day 1.
|
Group 8 (hzVSF-v13 1200mg)
Group 8 received a single 1200mg dose of hzVSF-v13 on Day 1.
|
Placebo
Placebo group received a single placebo on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Safety, Tolerability, Pharmacokinetic Characteristics of hzVSF-v13 in Healthy Male Volunteers
Baseline characteristics by cohort
| Measure |
Group 1 (hzVSF-v13 10mg)
n=3 Participants
Group 1 received a single 10mg dose of hzVSF-v13 on Day 1.
|
Group 2 (hzVSF-v13 20mg)
n=3 Participants
Group 2 received a single 20mg dose of hzVSF-v13 on Day 1.
|
Group 3 (hzVSF-v13 50mg)
n=6 Participants
Group 3 received a single 50mg dose of hzVSF-v13 on Day 1.
|
Group 4 (hzVSF-v13 100mg)
n=6 Participants
Group 4 received a single 100mg dose of hzVSF-v13 on Day 1.
|
Group 5 (hzVSF-v13 200mg)
n=6 Participants
Group 5 received a single 200mg dose of hzVSF-v13 on Day 1.
|
Group 6 (hzVSF-v13 400mg)
n=6 Participants
Group 6 received a single 400mg dose of hzVSF-v13 on Day 1.
|
Group 7 (hzVSF-v13 800mg)
n=6 Participants
Group 7 received a single 800mg dose of hzVSF-v13 on Day 1.
|
Group 8 (hzVSF-v13 1200mg)
n=6 Participants
Group 8 received a single 1200mg dose of hzVSF-v13 on Day 1.
|
Placebo
n=14 Participants
Placebo group received a single placebo on Day 1.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
34.7 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
32.0 years
STANDARD_DEVIATION 6.6 • n=7 Participants
|
32.8 years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
31.8 years
STANDARD_DEVIATION 4.5 • n=4 Participants
|
30.3 years
STANDARD_DEVIATION 7.2 • n=21 Participants
|
27.8 years
STANDARD_DEVIATION 4.9 • n=8 Participants
|
35.5 years
STANDARD_DEVIATION 5.5 • n=8 Participants
|
32.3 years
STANDARD_DEVIATION 5.9 • n=24 Participants
|
33.4 years
STANDARD_DEVIATION 6.5 • n=42 Participants
|
32.3 years
STANDARD_DEVIATION 5.9 • n=42 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
14 Participants
n=42 Participants
|
56 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
14 Participants
n=42 Participants
|
56 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
14 Participants
n=42 Participants
|
56 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Region of Enrollment
South Korea
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
14 Participants
n=42 Participants
|
56 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1176, 1512, 1848, 2184 hours (post-dose)Systolic Blood Pressure: ≤ 90 mmHg and decrease from baseline ≥ 20 mmHg, ≥ 140 mmHg and increase from baseline ≥ 20 mmHg Diastolic Blood Pressure: ≤ 50 mmHg and decrease from baseline ≥ 10 mmHg, ≥ 90 mmHg and increase from baseline ≥ 10 mmHg Heart Rate: ≤ 40 beats/min and decrease from baseline ≥ 20 beats/min, ≥ 100 beats/min and increase from baseline ≥ 20 beats/min
Outcome measures
| Measure |
Group 1 (hzVSF-v13 10mg)
n=3 Participants
Group 1 received a single 10mg dose of hzVSF-v13 on Day 1.
|
Group 2 (hzVSF-v13 20mg)
n=3 Participants
Group 2 received a single 20mg dose of hzVSF-v13 on Day 1.
|
Group 3 (hzVSF-v13 50mg)
n=6 Participants
Group 3 received a single 50mg dose of hzVSF-v13 on Day 1.
|
Group 4 (hzVSF-v13 100mg)
n=6 Participants
Group 4 received a single 100mg dose of hzVSF-v13 on Day 1.
|
Group 5 (hzVSF-v13 200mg)
n=6 Participants
Group 5 received a single 200mg dose of hzVSF-v13 on Day 1.
|
Group 6 (hzVSF-v13 400mg)
n=6 Participants
Group 6 received a single 400mg dose of hzVSF-v13 on Day 1.
|
Group 7 (hzVSF-v13 800mg)
n=6 Participants
Group 7 received a single 800mg dose of hzVSF-v13 on Day 1.
|
Group 8 (hzVSF-v13 1200mg)
n=6 Participants
Group 8 received a single 1200mg dose of hzVSF-v13 on Day 1.
|
Placebo
n=13 Participants
Placebo group received placebo on Day 1 (single administration).
|
|---|---|---|---|---|---|---|---|---|---|
|
Safety and Tolerability Assessments by Vital Signs
|
3 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1176, 1512, 1848, 2184 hours (post-dose)Population: Placebo group were not included in pharmacokinetic analysis set as the it was below the quantification limit.
Maximum observed Concentration of hzVSF-v13 from Day1 to Day92.
Outcome measures
| Measure |
Group 1 (hzVSF-v13 10mg)
n=3 Participants
Group 1 received a single 10mg dose of hzVSF-v13 on Day 1.
|
Group 2 (hzVSF-v13 20mg)
n=3 Participants
Group 2 received a single 20mg dose of hzVSF-v13 on Day 1.
|
Group 3 (hzVSF-v13 50mg)
n=6 Participants
Group 3 received a single 50mg dose of hzVSF-v13 on Day 1.
|
Group 4 (hzVSF-v13 100mg)
n=6 Participants
Group 4 received a single 100mg dose of hzVSF-v13 on Day 1.
|
Group 5 (hzVSF-v13 200mg)
n=5 Participants
Group 5 received a single 200mg dose of hzVSF-v13 on Day 1.
|
Group 6 (hzVSF-v13 400mg)
n=6 Participants
Group 6 received a single 400mg dose of hzVSF-v13 on Day 1.
|
Group 7 (hzVSF-v13 800mg)
n=6 Participants
Group 7 received a single 800mg dose of hzVSF-v13 on Day 1.
|
Group 8 (hzVSF-v13 1200mg)
n=5 Participants
Group 8 received a single 1200mg dose of hzVSF-v13 on Day 1.
|
Placebo
Placebo group received placebo on Day 1 (single administration).
|
|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic Characteristics - Cmax (Concentration Maximum)
|
1.77 mg/L
Standard Deviation 0.47
|
4.38 mg/L
Standard Deviation 1.31
|
14.04 mg/L
Standard Deviation 2.35
|
27.26 mg/L
Standard Deviation 5.82
|
45.39 mg/L
Standard Deviation 7.43
|
99.00 mg/L
Standard Deviation 14.07
|
174.43 mg/L
Standard Deviation 26.66
|
268.09 mg/L
Standard Deviation 28.07
|
—
|
SECONDARY outcome
Timeframe: 0 (pre-dose), 0.5, 1, 2, 4, 6, 8, 10, 12, 24, 36, 48, 60, 72, 96, 120, 144, 168, 336, 504, 672, 840, 1176, 1512, 1848, 2184 hours (post-dose)Population: Placebo group were not included in pharmacokinetic analysis set as the it was below the quantification limit.
Area under the plasma concentration from Day1 to time of last measurable concentration.
Outcome measures
| Measure |
Group 1 (hzVSF-v13 10mg)
n=3 Participants
Group 1 received a single 10mg dose of hzVSF-v13 on Day 1.
|
Group 2 (hzVSF-v13 20mg)
n=3 Participants
Group 2 received a single 20mg dose of hzVSF-v13 on Day 1.
|
Group 3 (hzVSF-v13 50mg)
n=6 Participants
Group 3 received a single 50mg dose of hzVSF-v13 on Day 1.
|
Group 4 (hzVSF-v13 100mg)
n=6 Participants
Group 4 received a single 100mg dose of hzVSF-v13 on Day 1.
|
Group 5 (hzVSF-v13 200mg)
n=5 Participants
Group 5 received a single 200mg dose of hzVSF-v13 on Day 1.
|
Group 6 (hzVSF-v13 400mg)
n=6 Participants
Group 6 received a single 400mg dose of hzVSF-v13 on Day 1.
|
Group 7 (hzVSF-v13 800mg)
n=6 Participants
Group 7 received a single 800mg dose of hzVSF-v13 on Day 1.
|
Group 8 (hzVSF-v13 1200mg)
n=5 Participants
Group 8 received a single 1200mg dose of hzVSF-v13 on Day 1.
|
Placebo
Placebo group received placebo on Day 1 (single administration).
|
|---|---|---|---|---|---|---|---|---|---|
|
PK - AUClast (Area Under the Curve Last)
|
176.74 h·mg/L
Standard Deviation 35.76
|
1264.31 h·mg/L
Standard Deviation 315.53
|
4554.13 h·mg/L
Standard Deviation 1143.05
|
8226.23 h·mg/L
Standard Deviation 2766.32
|
17386.38 h·mg/L
Standard Deviation 5362.11
|
39032.00 h·mg/L
Standard Deviation 7672.94
|
80395.46 h·mg/L
Standard Deviation 9269.87
|
102677.10 h·mg/L
Standard Deviation 25759.47
|
—
|
Adverse Events
Group 1 (hzVSF-v13 10mg)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2 (hzVSF-v13 20mg)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 3 (hzVSF-v13 50mg)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 4 (hzVSF-v13 100mg)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 5 (hzVSF-v13 200mg)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 6 (hzVSF-v13 400mg)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 7 (hzVSF-v13 800mg)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 8 (hzVSF-v13 1200mg)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place