Trial Outcomes & Findings for A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of N-Rephasin® SAL200 in Healthy Male Volunteers (NCT NCT01855048)
NCT ID: NCT01855048
Last Updated: 2021-11-03
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
36 participants
Primary outcome timeframe
Up to 50 days after administration
Results posted on
2021-11-03
Participant Flow
Enrollment have completed in a single center (Seoul National University Hospital) from Nov. 2013 and the completion date is Feb. 2014.
57 subjects were screened and 36 subjects met the eligibility criteria.
Participant milestones
| Measure |
INT200-Placebo
Placebo
INT200-Placebo: Formulation buffer for continuous intravenous infusion over 60 minutes
|
N-Rephasin® SAL200, 0.1mg/kg
N-Rephasin® SAL200: continuous intravenous infusion over 60 minutes
|
N-Rephasin® SAL200, 0.3 mg/kg
N-Rephasin® SAL200: continuous intravenous infusion over 60 minutes
|
N-Rephasin® SAL200, 1 mg/kg
N-Rephasin® SAL200: continuous intravenous infusion over 60 minutes
|
N-Rephasin® SAL200, 3 mg/kg
N-Rephasin® SAL200: continuous intravenous infusion over 60 minutes
|
N-Rephasin® SAL200, 10 mg/kg
N-Rephasin® SAL200: continuous intravenous infusion over 60 minutes
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
3
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
9
|
2
|
6
|
6
|
5
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
INT200-Placebo
Placebo
INT200-Placebo: Formulation buffer for continuous intravenous infusion over 60 minutes
|
N-Rephasin® SAL200, 0.1mg/kg
N-Rephasin® SAL200: continuous intravenous infusion over 60 minutes
|
N-Rephasin® SAL200, 0.3 mg/kg
N-Rephasin® SAL200: continuous intravenous infusion over 60 minutes
|
N-Rephasin® SAL200, 1 mg/kg
N-Rephasin® SAL200: continuous intravenous infusion over 60 minutes
|
N-Rephasin® SAL200, 3 mg/kg
N-Rephasin® SAL200: continuous intravenous infusion over 60 minutes
|
N-Rephasin® SAL200, 10 mg/kg
N-Rephasin® SAL200: continuous intravenous infusion over 60 minutes
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of N-Rephasin® SAL200 in Healthy Male Volunteers
Baseline characteristics by cohort
| Measure |
N-Rephasin® SAL200 0.1(mg/kg)
n=3 Participants
N-Rephasin® SAL200, 0.1 mg/kg
N-Rephasin® SAL200: continuous intravenous infusion over 60 minutes
|
N-Rephasin® SAL200 0.3(mg/kg)
n=6 Participants
N-Rephasin® SAL200, 0.3 mg/kg
N-Rephasin® SAL200: continuous intravenous infusion over 60 minutes
|
N-Rephasin® SAL200 1(mg/kg)
n=6 Participants
N-Rephasin® SAL200,
1 mg/kg
N-Rephasin® SAL200: continuous intravenous infusion over 60 minutes
|
N-Rephasin® SAL200 3(mg/kg)
n=6 Participants
N-Rephasin® SAL200, 3 mg/kg
N-Rephasin® SAL200: continuous intravenous infusion over 60 minutes
|
N-Rephasin® SAL200 10(mg/kg)
n=6 Participants
N-Rephasin® SAL200, 10 mg/kg
N-Rephasin® SAL200: continuous intravenous infusion over 60 minutes
|
INT200-Placebo
n=9 Participants
Placebo
INT200-Placebo: Formulation buffer for continuous intravenous infusion over 60 minutes
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Customized
|
25.3 Years
n=5 Participants
|
27.8 Years
n=7 Participants
|
29.8 Years
n=5 Participants
|
23.7 Years
n=4 Participants
|
30.5 Years
n=21 Participants
|
26.2 Years
n=10 Participants
|
27.4 Years
n=115 Participants
|
|
Sex/Gender, Customized
Male
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
36 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
9 Participants
n=10 Participants
|
36 Participants
n=115 Participants
|
|
Region of Enrollment
South Korea
|
3 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
6 participants
n=21 Participants
|
9 participants
n=10 Participants
|
36 participants
n=115 Participants
|
|
Body weight
|
67.1 kg
n=5 Participants
|
65.5 kg
n=7 Participants
|
74.0 kg
n=5 Participants
|
69.1 kg
n=4 Participants
|
68.7 kg
n=21 Participants
|
68.1 kg
n=10 Participants
|
68.9 kg
n=115 Participants
|
|
Height
|
176.8 cm
n=5 Participants
|
171.3 cm
n=7 Participants
|
175.1 cm
n=5 Participants
|
174.8 cm
n=4 Participants
|
170.5 cm
n=21 Participants
|
174.5 cm
n=10 Participants
|
173.6 cm
n=115 Participants
|
PRIMARY outcome
Timeframe: Up to 50 days after administrationOutcome measures
| Measure |
Placebo
n=9 Participants
INT200-Placebo, IV administration
|
N-Rephasin® SAL200 (0.1 mg/kg)
n=3 Participants
Study drug 0.0056 mL/kg, IV administration
|
N-Rephasin® SAL200 (0.3 mg/kg)
n=6 Participants
Study drug 0.017 mL/kg, IV administration
|
N-Rephasin® SAL200 (1 mg/kg)
n=6 Participants
Study drug 0.056 mL/kg, IV administration
|
N-Rephasin® SAL200 (3 mg/kg)
n=6 Participants
Study drug 0.167 mL/kg, IV administration
|
N-Rephasin® SAL200 (10 mg/kg)
n=6 Participants
Study drug 0.556 mL/kg, IV administration
|
|---|---|---|---|---|---|---|
|
Evaluation of the Safety of N-Rephasin® SAL200 in Healthy Human Volunteers
Number of Subjects with at least one AE
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
6 Participants
|
|
Evaluation of the Safety of N-Rephasin® SAL200 in Healthy Human Volunteers
Number of Subjects with at least one drug-related AE
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
6 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0, 4, 8, 12, 16, 20, 24 hours post-doseOutcome measures
| Measure |
Placebo
n=3 Participants
INT200-Placebo, IV administration
|
N-Rephasin® SAL200 (0.1 mg/kg)
n=6 Participants
Study drug 0.0056 mL/kg, IV administration
|
N-Rephasin® SAL200 (0.3 mg/kg)
n=6 Participants
Study drug 0.017 mL/kg, IV administration
|
N-Rephasin® SAL200 (1 mg/kg)
n=6 Participants
Study drug 0.056 mL/kg, IV administration
|
N-Rephasin® SAL200 (3 mg/kg)
n=6 Participants
Study drug 0.167 mL/kg, IV administration
|
N-Rephasin® SAL200 (10 mg/kg)
Study drug 0.556 mL/kg, IV administration
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic Parameters After Single IV Administration of N-Rephasin® SAL200 [Effective t1/2 (h)]
|
0.04 h
Standard Deviation 0.02
|
0.04 h
Standard Deviation 0.01
|
0.25 h
Standard Deviation 0.05
|
0.38 h
Standard Deviation 0.06
|
0.38 h
Standard Deviation 0.05
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 2hoursOutcome measures
| Measure |
Placebo
n=3 Participants
INT200-Placebo, IV administration
|
N-Rephasin® SAL200 (0.1 mg/kg)
n=6 Participants
Study drug 0.0056 mL/kg, IV administration
|
N-Rephasin® SAL200 (0.3 mg/kg)
n=6 Participants
Study drug 0.017 mL/kg, IV administration
|
N-Rephasin® SAL200 (1 mg/kg)
n=6 Participants
Study drug 0.056 mL/kg, IV administration
|
N-Rephasin® SAL200 (3 mg/kg)
n=6 Participants
Study drug 0.167 mL/kg, IV administration
|
N-Rephasin® SAL200 (10 mg/kg)
Study drug 0.556 mL/kg, IV administration
|
|---|---|---|---|---|---|---|
|
Pharmacodynamics Evaluation of N-Rephasin® SAL200 : Mean Concentration of Bactericidal Activity After Single Dose of N-Rephsin® SAL200 IV Administration
0h
|
0 μg/mL
Standard Deviation 0
|
0 μg/mL
Standard Deviation 0
|
0 μg/mL
Standard Deviation 0
|
0 μg/mL
Standard Deviation 0
|
0 μg/mL
Standard Deviation 0
|
—
|
|
Pharmacodynamics Evaluation of N-Rephasin® SAL200 : Mean Concentration of Bactericidal Activity After Single Dose of N-Rephsin® SAL200 IV Administration
2h
|
0 μg/mL
Standard Deviation 0
|
0 μg/mL
Standard Deviation 0
|
0 μg/mL
Standard Deviation 0
|
0 μg/mL
Standard Deviation 0
|
0.04 μg/mL
Standard Deviation 0.05
|
—
|
|
Pharmacodynamics Evaluation of N-Rephasin® SAL200 : Mean Concentration of Bactericidal Activity After Single Dose of N-Rephsin® SAL200 IV Administration
1h
|
0 μg/mL
Standard Deviation 0
|
0 μg/mL
Standard Deviation 0
|
0.13 μg/mL
Standard Deviation 0.05
|
0.22 μg/mL
Standard Deviation 0.10
|
0.40 μg/mL
Standard Deviation 0.13
|
—
|
|
Pharmacodynamics Evaluation of N-Rephasin® SAL200 : Mean Concentration of Bactericidal Activity After Single Dose of N-Rephsin® SAL200 IV Administration
1.5h
|
0 μg/mL
Standard Deviation 0
|
0 μg/mL
Standard Deviation 0
|
0 μg/mL
Standard Deviation 0
|
0 μg/mL
Standard Deviation 0
|
0.15 μg/mL
Standard Deviation 0.06
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 to 2Outcome measures
| Measure |
Placebo
n=3 Participants
INT200-Placebo, IV administration
|
N-Rephasin® SAL200 (0.1 mg/kg)
n=6 Participants
Study drug 0.0056 mL/kg, IV administration
|
N-Rephasin® SAL200 (0.3 mg/kg)
n=6 Participants
Study drug 0.017 mL/kg, IV administration
|
N-Rephasin® SAL200 (1 mg/kg)
n=6 Participants
Study drug 0.056 mL/kg, IV administration
|
N-Rephasin® SAL200 (3 mg/kg)
n=6 Participants
Study drug 0.167 mL/kg, IV administration
|
N-Rephasin® SAL200 (10 mg/kg)
Study drug 0.556 mL/kg, IV administration
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic Evaluation of N-Rephasin® SAL200 at the Administered Doses by Analysis of Concentration of N-Rephasin® SAL200 in Serum [Cmax (µg/ml)]
|
0.04 µg/ml
Standard Deviation 0.01
|
0.09 µg/ml
Standard Deviation 0.04
|
0.82 µg/ml
Standard Deviation 0.50
|
7.10 µg/ml
Standard Deviation 5.39
|
55.99 µg/ml
Standard Deviation 10.37
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 to 2Outcome measures
| Measure |
Placebo
n=3 Participants
INT200-Placebo, IV administration
|
N-Rephasin® SAL200 (0.1 mg/kg)
n=6 Participants
Study drug 0.0056 mL/kg, IV administration
|
N-Rephasin® SAL200 (0.3 mg/kg)
n=6 Participants
Study drug 0.017 mL/kg, IV administration
|
N-Rephasin® SAL200 (1 mg/kg)
n=6 Participants
Study drug 0.056 mL/kg, IV administration
|
N-Rephasin® SAL200 (3 mg/kg)
n=6 Participants
Study drug 0.167 mL/kg, IV administration
|
N-Rephasin® SAL200 (10 mg/kg)
Study drug 0.556 mL/kg, IV administration
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic Evaluation of N-Rephasin® SAL200 at the Administered Doses by Analysis of Concentration of N-Rephasin® SAL200 in Serum [Cmax/D (µg/ml/mg)]
|
0.01 µg/ml/mg
Standard Deviation 0.001
|
0.005 µg/ml/mg
Standard Deviation 0.001
|
0.01 µg/ml/mg
Standard Deviation 0.01
|
0.03 µg/ml/mg
Standard Deviation 0.02
|
0.08 µg/ml/mg
Standard Deviation 0.01
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 to 2Outcome measures
| Measure |
Placebo
n=3 Participants
INT200-Placebo, IV administration
|
N-Rephasin® SAL200 (0.1 mg/kg)
n=69 Participants
Study drug 0.0056 mL/kg, IV administration
|
N-Rephasin® SAL200 (0.3 mg/kg)
n=6 Participants
Study drug 0.017 mL/kg, IV administration
|
N-Rephasin® SAL200 (1 mg/kg)
n=6 Participants
Study drug 0.056 mL/kg, IV administration
|
N-Rephasin® SAL200 (3 mg/kg)
n=6 Participants
Study drug 0.167 mL/kg, IV administration
|
N-Rephasin® SAL200 (10 mg/kg)
Study drug 0.556 mL/kg, IV administration
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic Evaluation of N-Rephasin® SAL200 at the Administered Doses by Analysis of Concentration of N-Rephasin® SAL200 in Serum [AUC Last (µg*h/ml)]
|
0.03 µg*h/ml
Standard Deviation 0.005
|
0.05 µg*h/ml
Standard Deviation 0.02
|
0.57 µg*h/ml
Standard Deviation 0.31
|
7.26 µg*h/ml
Standard Deviation 3.42
|
59.79 µg*h/ml
Standard Deviation 9.03
|
—
|
Adverse Events
INT200-Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
N-Rephasin® SAL200, 0.1mg/kg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
N-Rephasin® SAL200, 0.3 mg/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
N-Rephasin® SAL200, 1 mg/kg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
N-Rephasin® SAL200, 3 mg/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
N-Rephasin® SAL200, 10 mg/kg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
INT200-Placebo
n=9 participants at risk
Placebo
INT200-Placebo: Formulation buffer for continuous intravenous infusion over 60 minutes
|
N-Rephasin® SAL200, 0.1mg/kg
n=3 participants at risk
N-Rephasin® SAL200: continuous intravenous infusion over 60 minutes
|
N-Rephasin® SAL200, 0.3 mg/kg
n=6 participants at risk
N-Rephasin® SAL200: continuous intravenous infusion over 60 minutes
|
N-Rephasin® SAL200, 1 mg/kg
n=6 participants at risk
N-Rephasin® SAL200: continuous intravenous infusion over 60 minutes
|
N-Rephasin® SAL200, 3 mg/kg
n=6 participants at risk
N-Rephasin® SAL200: continuous intravenous infusion over 60 minutes
|
N-Rephasin® SAL200, 10 mg/kg
n=6 participants at risk
N-Rephasin® SAL200: continuous intravenous infusion over 60 minutes
|
|---|---|---|---|---|---|---|
|
General disorders
Fatigue
|
0.00%
0/9 • Up to 50 Days ± 7 Days
|
0.00%
0/3 • Up to 50 Days ± 7 Days
|
0.00%
0/6 • Up to 50 Days ± 7 Days
|
0.00%
0/6 • Up to 50 Days ± 7 Days
|
0.00%
0/6 • Up to 50 Days ± 7 Days
|
50.0%
3/6 • Number of events 3 • Up to 50 Days ± 7 Days
|
|
General disorders
Fever
|
0.00%
0/9 • Up to 50 Days ± 7 Days
|
0.00%
0/3 • Up to 50 Days ± 7 Days
|
0.00%
0/6 • Up to 50 Days ± 7 Days
|
0.00%
0/6 • Up to 50 Days ± 7 Days
|
0.00%
0/6 • Up to 50 Days ± 7 Days
|
16.7%
1/6 • Number of events 1 • Up to 50 Days ± 7 Days
|
|
General disorders
Rigors
|
0.00%
0/9 • Up to 50 Days ± 7 Days
|
0.00%
0/3 • Up to 50 Days ± 7 Days
|
33.3%
2/6 • Number of events 2 • Up to 50 Days ± 7 Days
|
0.00%
0/6 • Up to 50 Days ± 7 Days
|
0.00%
0/6 • Up to 50 Days ± 7 Days
|
66.7%
4/6 • Number of events 4 • Up to 50 Days ± 7 Days
|
|
Respiratory, thoracic and mediastinal disorders
Coughing
|
0.00%
0/9 • Up to 50 Days ± 7 Days
|
0.00%
0/3 • Up to 50 Days ± 7 Days
|
0.00%
0/6 • Up to 50 Days ± 7 Days
|
16.7%
1/6 • Number of events 1 • Up to 50 Days ± 7 Days
|
0.00%
0/6 • Up to 50 Days ± 7 Days
|
16.7%
1/6 • Number of events 1 • Up to 50 Days ± 7 Days
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
0.00%
0/9 • Up to 50 Days ± 7 Days
|
0.00%
0/3 • Up to 50 Days ± 7 Days
|
0.00%
0/6 • Up to 50 Days ± 7 Days
|
16.7%
1/6 • Number of events 1 • Up to 50 Days ± 7 Days
|
16.7%
1/6 • Number of events 1 • Up to 50 Days ± 7 Days
|
16.7%
1/6 • Number of events 1 • Up to 50 Days ± 7 Days
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
0.00%
0/9 • Up to 50 Days ± 7 Days
|
0.00%
0/3 • Up to 50 Days ± 7 Days
|
0.00%
0/6 • Up to 50 Days ± 7 Days
|
16.7%
1/6 • Number of events 1 • Up to 50 Days ± 7 Days
|
0.00%
0/6 • Up to 50 Days ± 7 Days
|
66.7%
4/6 • Number of events 4 • Up to 50 Days ± 7 Days
|
|
Nervous system disorders
Headache
|
11.1%
1/9 • Number of events 3 • Up to 50 Days ± 7 Days
|
0.00%
0/3 • Up to 50 Days ± 7 Days
|
0.00%
0/6 • Up to 50 Days ± 7 Days
|
0.00%
0/6 • Up to 50 Days ± 7 Days
|
0.00%
0/6 • Up to 50 Days ± 7 Days
|
50.0%
3/6 • Number of events 3 • Up to 50 Days ± 7 Days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/9 • Up to 50 Days ± 7 Days
|
0.00%
0/3 • Up to 50 Days ± 7 Days
|
0.00%
0/6 • Up to 50 Days ± 7 Days
|
0.00%
0/6 • Up to 50 Days ± 7 Days
|
0.00%
0/6 • Up to 50 Days ± 7 Days
|
33.3%
2/6 • Number of events 2 • Up to 50 Days ± 7 Days
|
|
Nervous system disorders
Syncope
|
0.00%
0/9 • Up to 50 Days ± 7 Days
|
0.00%
0/3 • Up to 50 Days ± 7 Days
|
16.7%
1/6 • Number of events 1 • Up to 50 Days ± 7 Days
|
0.00%
0/6 • Up to 50 Days ± 7 Days
|
0.00%
0/6 • Up to 50 Days ± 7 Days
|
0.00%
0/6 • Up to 50 Days ± 7 Days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/9 • Up to 50 Days ± 7 Days
|
0.00%
0/3 • Up to 50 Days ± 7 Days
|
0.00%
0/6 • Up to 50 Days ± 7 Days
|
0.00%
0/6 • Up to 50 Days ± 7 Days
|
16.7%
1/6 • Number of events 1 • Up to 50 Days ± 7 Days
|
16.7%
1/6 • Number of events 1 • Up to 50 Days ± 7 Days
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/9 • Up to 50 Days ± 7 Days
|
0.00%
0/3 • Up to 50 Days ± 7 Days
|
0.00%
0/6 • Up to 50 Days ± 7 Days
|
0.00%
0/6 • Up to 50 Days ± 7 Days
|
16.7%
1/6 • Number of events 1 • Up to 50 Days ± 7 Days
|
0.00%
0/6 • Up to 50 Days ± 7 Days
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/9 • Up to 50 Days ± 7 Days
|
0.00%
0/3 • Up to 50 Days ± 7 Days
|
0.00%
0/6 • Up to 50 Days ± 7 Days
|
0.00%
0/6 • Up to 50 Days ± 7 Days
|
0.00%
0/6 • Up to 50 Days ± 7 Days
|
33.3%
2/6 • Number of events 2 • Up to 50 Days ± 7 Days
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/9 • Up to 50 Days ± 7 Days
|
0.00%
0/3 • Up to 50 Days ± 7 Days
|
0.00%
0/6 • Up to 50 Days ± 7 Days
|
0.00%
0/6 • Up to 50 Days ± 7 Days
|
0.00%
0/6 • Up to 50 Days ± 7 Days
|
16.7%
1/6 • Number of events 1 • Up to 50 Days ± 7 Days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/9 • Up to 50 Days ± 7 Days
|
0.00%
0/3 • Up to 50 Days ± 7 Days
|
0.00%
0/6 • Up to 50 Days ± 7 Days
|
0.00%
0/6 • Up to 50 Days ± 7 Days
|
0.00%
0/6 • Up to 50 Days ± 7 Days
|
16.7%
1/6 • Number of events 1 • Up to 50 Days ± 7 Days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/9 • Up to 50 Days ± 7 Days
|
0.00%
0/3 • Up to 50 Days ± 7 Days
|
16.7%
1/6 • Number of events 1 • Up to 50 Days ± 7 Days
|
0.00%
0/6 • Up to 50 Days ± 7 Days
|
0.00%
0/6 • Up to 50 Days ± 7 Days
|
33.3%
2/6 • Number of events 3 • Up to 50 Days ± 7 Days
|
|
Vascular disorders
Hypotension
|
0.00%
0/9 • Up to 50 Days ± 7 Days
|
0.00%
0/3 • Up to 50 Days ± 7 Days
|
0.00%
0/6 • Up to 50 Days ± 7 Days
|
0.00%
0/6 • Up to 50 Days ± 7 Days
|
0.00%
0/6 • Up to 50 Days ± 7 Days
|
16.7%
1/6 • Number of events 1 • Up to 50 Days ± 7 Days
|
|
Hepatobiliary disorders
Bilirubinaemia
|
0.00%
0/9 • Up to 50 Days ± 7 Days
|
0.00%
0/3 • Up to 50 Days ± 7 Days
|
16.7%
1/6 • Number of events 1 • Up to 50 Days ± 7 Days
|
0.00%
0/6 • Up to 50 Days ± 7 Days
|
0.00%
0/6 • Up to 50 Days ± 7 Days
|
0.00%
0/6 • Up to 50 Days ± 7 Days
|
Additional Information
Jun SooYoun, Ph.D. / Executive Director/ Principal researcher
Organization:Institute of iNtRON Biotechnology
Phone: +82-31-739-5332
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place