Trial Outcomes & Findings for A Study to Evaluate the Safety, PK, PD, Immunogenicity of N-Rephasin® SAL200 in Healthy Male Volunteers (NCT NCT03446053)
NCT ID: NCT03446053
Last Updated: 2021-11-03
Results Overview
Monitoring of adverse events (AEs) for Safety and Tolerability Evaluation
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
33 participants
Primary outcome timeframe
Up to 50D (±2D)
Results posted on
2021-11-03
Participant Flow
The recruitment was conducted in a single center (SEOUL NATIONAL UNIVERSITY HOSPITAL) from Feb. 2018 to Dec. 2018.
59 subjects were screened and 33 subjects met inclusion criteria and were randomized to treatment.
Participant milestones
| Measure |
Placebo, Single Dose Study
INT200-Placebo, single dose, IP administration: 1d 0h
|
N-Rephasin® SAL200 6mg/kg (Single Dose)
Sigle dose group N-Rephasin® SAL200 6mg/kg (single dose)
Experimental: N-Rephasin® SAL200
Active ingredient : SAL200 1ml (SAL-1 18 mg/mL) Manufacturer: BINEX Co., Ltd. (whole process contracted) Transparent and colorless vial filled with colorless clear liquid injection
continuous intravenous infusion over 60 minutes
Healthy Volunteers who were met eligibility criteria.
|
Placebo , Multiple Dose Study
INT200-Placebo, multiple dose, IP administration: 1d 0h, 2d 0h, 2d 12h, 3d 0h, 3d 12h and 4d 0h
|
N-Rephasin® SAL200 1.5 mg/kg (3mg/kg/d) , Multi Dose
multi dose study Experimental: N-Rephasin® SAL200
Active ingredient : SAL200 1ml (SAL-1 18 mg/mL) Manufacturer: BINEX Co., Ltd. (whole process contracted) Transparent and colorless vial filled with colorless clear liquid injection
continuous intravenous infusion over 60 minutes
Healthy Volunteers who were met eligibility criteria.
|
N-Rephasin® SAL200 3mg/kg (6mg/kg/d), Multi Dose
Multi dose study Experimental: N-Rephasin® SAL200
Active ingredient : SAL200 1ml (SAL-1 18 mg/mL) Manufacturer: BINEX Co., Ltd. (whole process contracted) Transparent and colorless vial filled with colorless clear liquid injection
continuous intravenous infusion over 60 minutes
Healthy Volunteers who were met eligibility criteria.
|
N-Rephasin® SAL200 4.5mg/kg (9mg/kg/d), Multi Dose
Multi dose study Experimental: N-Rephasin® SAL200
Active ingredient : SAL200 1ml (SAL-1 18 mg/mL) Manufacturer: BINEX Co., Ltd. (whole process contracted) Transparent and colorless vial filled with colorless clear liquid injection
continuous intravenous infusion over 60 minutes
Healthy Volunteers who were met eligibility criteria.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
6
|
6
|
7
|
6
|
6
|
|
Overall Study
Randomized Set
|
2
|
6
|
6
|
7
|
6
|
6
|
|
Overall Study
Safety Analysis Set
|
2
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
PK/PD Analysis Set
|
2
|
6
|
6
|
6
|
6
|
5
|
|
Overall Study
COMPLETED
|
2
|
5
|
6
|
6
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
1
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Safety, PK, PD, Immunogenicity of N-Rephasin® SAL200 in Healthy Male Volunteers
Baseline characteristics by cohort
| Measure |
INT200-Placebo (Single Dose Study + Multi Dose Study)
n=8 Participants
Saline
INT200-Placebo: Formulation buffer except active ingredient for continuous intravenous infusion over 60 minutes
|
N-Rephasin® SAL200 6mg/kg (Single Dose)
n=6 Participants
Sigle dose N-Rephasin® SAL200 6mg/kg (single dose)
Experimental: N-Rephasin® SAL200
Active ingredient : SAL200 1ml (SAL-1 18 mg/mL) Manufacturer: BINEX Co., Ltd. (whole process contracted) Transparent and colorless vial filled with colorless clear liquid injection
continuous intravenous infusion over 60 minutes
Healthy Volunteers who were met eligibility criteria.
|
N-Rephasin® SAL200 1.5 mg/kg (3mg/kg/d), Multi Dose
n=6 Participants
Multi dose Experimental: N-Rephasin® SAL200
Active ingredient : SAL200 1ml (SAL-1 18 mg/mL) Manufacturer: BINEX Co., Ltd. (whole process contracted) Transparent and colorless vial filled with colorless clear liquid injection
continuous intravenous infusion over 60 minutes
Healthy Volunteers who were met eligibility criteria.
|
N-Rephasin® SAL200 3mg/kg (6mg/kg/d), Multi Dose
n=6 Participants
Multi dose Experimental: N-Rephasin® SAL200
Active ingredient : SAL200 1ml (SAL-1 18 mg/mL) Manufacturer: BINEX Co., Ltd. (whole process contracted) Transparent and colorless vial filled with colorless clear liquid injection
continuous intravenous infusion over 60 minutes
Healthy Volunteers who were met eligibility criteria.
|
N-Rephasin® SAL200 4.5mg/kg (9mg/kg/d), Multi Dose
n=6 Participants
Multi dose Experimental: N-Rephasin® SAL200
Active ingredient : SAL200 1ml (SAL-1 18 mg/mL) Manufacturer: BINEX Co., Ltd. (whole process contracted) Transparent and colorless vial filled with colorless clear liquid injection
continuous intravenous infusion over 60 minutes
Healthy Volunteers who were met eligibility criteria.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
Age
|
29.0 years
STANDARD_DEVIATION 5.6 • n=5 Participants
|
28.5 years
STANDARD_DEVIATION 6.0 • n=7 Participants
|
33.5 years
STANDARD_DEVIATION 6.2 • n=5 Participants
|
31.3 years
STANDARD_DEVIATION 5.8 • n=4 Participants
|
29.2 years
STANDARD_DEVIATION 4.9 • n=21 Participants
|
30.2 years
STANDARD_DEVIATION 5.6 • n=8 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
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
32 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
32 Participants
n=8 Participants
|
|
Weight
|
77.2 kg
STANDARD_DEVIATION 8.8 • n=5 Participants
|
73.1 kg
STANDARD_DEVIATION 5.5 • n=7 Participants
|
70.3 kg
STANDARD_DEVIATION 9.1 • n=5 Participants
|
74.2 kg
STANDARD_DEVIATION 5.9 • n=4 Participants
|
69.1 kg
STANDARD_DEVIATION 8.7 • n=21 Participants
|
73.0 kg
STANDARD_DEVIATION 7.9 • n=8 Participants
|
|
Height
|
178.1 cm
STANDARD_DEVIATION 6.2 • n=5 Participants
|
175.0 cm
STANDARD_DEVIATION 4.6 • n=7 Participants
|
174.0 cm
STANDARD_DEVIATION 3.6 • n=5 Participants
|
174.5 cm
STANDARD_DEVIATION 2.5 • n=4 Participants
|
174.7 cm
STANDARD_DEVIATION 4.9 • n=21 Participants
|
175.4 cm
STANDARD_DEVIATION 4.7 • n=8 Participants
|
PRIMARY outcome
Timeframe: Up to 50D (±2D)Monitoring of adverse events (AEs) for Safety and Tolerability Evaluation
Outcome measures
| Measure |
Placebo, Single Dose Study
n=2 Participants
INT200-Placebo, single dose, IP administration: 1d 0h
|
N-Rephasin® SAL200 (6mg/kg), Single Dose Study
n=6 Participants
SAL200 1 ml (SAL-1 18 mg/mL), 6 mg/kg, single dose, IP administration: 1d 0h
|
Placebo , Multiple Dose Study
n=6 Participants
INT200-Placebo, multiple dose, IP administration: 1d 0h, 2d 0h, 2d 12h, 3d 0h, 3d 12h and 4d 0h
|
N-Rephasin® SAL200 (1.5 mg/kg), Multiple Dose Study
n=6 Participants
SAL200 1 ml (SAL-1 18 mg/mL), 1.5 mg/kg (3 mg/kg/day), Multiple dose, IP administration: 1d 0h, 2d 0h, 2d 12h, 3d 0h, 3d 12h and 4d 0h
|
N-Rephasin® SAL200 (3 mg/kg), Multiple Dose Study
n=6 Participants
SAL200 1 ml (SAL-1 18 mg/mL), 3 mg (6 mg/kg/day) , Multiple dose, IP administration: 1d 0h, 2d 0h, 2d 12h, 3d 0h, 3d 12h and 4d 0h
|
N-Rephasin® SAL200 (4.5 mg/kg), Multiple Dose Study
n=6 Participants
SAL200 1 ml (SAL-1 18 mg/mL), 4.5 mg (9 mg/kg/day), Multiple dose, IP administration: 1d 0h, 2d 0h, 2d 12h, 3d 0h, 3d 12h and 4d 0h
|
|---|---|---|---|---|---|---|
|
Safety and Tolerability Evaluation
No. of Subjects with TEAEs
|
1 Participants
|
6 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
|
Safety and Tolerability Evaluation
No. of Subjects with Drug-Related TEAEs
|
0 Participants
|
5 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Safety and Tolerability Evaluation
No. of Subjects with Serious TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Single administration: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours post-dose Multiple administration: the above timepoints and 25, 36, 48, 49, 60, 72, 72.25, 72.5, 72.75, 73, 73.5, 74, 75, 76, 77, 78, 80, 82, 84, 96 hours post-doseBlood sampling for PK evaluation was performed at the following time points. Summary of PK parameters after single IV administration of N-Rephasin® SAL200.
Outcome measures
| Measure |
Placebo, Single Dose Study
n=6 Participants
INT200-Placebo, single dose, IP administration: 1d 0h
|
N-Rephasin® SAL200 (6mg/kg), Single Dose Study
n=6 Participants
SAL200 1 ml (SAL-1 18 mg/mL), 6 mg/kg, single dose, IP administration: 1d 0h
|
Placebo , Multiple Dose Study
n=6 Participants
INT200-Placebo, multiple dose, IP administration: 1d 0h, 2d 0h, 2d 12h, 3d 0h, 3d 12h and 4d 0h
|
N-Rephasin® SAL200 (1.5 mg/kg), Multiple Dose Study
n=5 Participants
SAL200 1 ml (SAL-1 18 mg/mL), 1.5 mg/kg (3 mg/kg/day), Multiple dose, IP administration: 1d 0h, 2d 0h, 2d 12h, 3d 0h, 3d 12h and 4d 0h
|
N-Rephasin® SAL200 (3 mg/kg), Multiple Dose Study
SAL200 1 ml (SAL-1 18 mg/mL), 3 mg (6 mg/kg/day) , Multiple dose, IP administration: 1d 0h, 2d 0h, 2d 12h, 3d 0h, 3d 12h and 4d 0h
|
N-Rephasin® SAL200 (4.5 mg/kg), Multiple Dose Study
SAL200 1 ml (SAL-1 18 mg/mL), 4.5 mg (9 mg/kg/day), Multiple dose, IP administration: 1d 0h, 2d 0h, 2d 12h, 3d 0h, 3d 12h and 4d 0h
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic Evaluation [Cmax (µg/mL)]
|
21.4 µg/mL
Standard Deviation 3.91
|
1.24 µg/mL
Standard Deviation 0.509
|
4.93 µg/mL
Standard Deviation 1.08
|
10.8 µg/mL
Standard Deviation 1.53
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 2hoursEx vivo antibacterial activity was assessed by bactericidal effects of the serum specimens collected from the trials were compared with calibration samples range of 0.05 to 1.0 μg/mL N-Rephasin®SAL200.
Outcome measures
| Measure |
Placebo, Single Dose Study
n=6 Participants
INT200-Placebo, single dose, IP administration: 1d 0h
|
N-Rephasin® SAL200 (6mg/kg), Single Dose Study
n=6 Participants
SAL200 1 ml (SAL-1 18 mg/mL), 6 mg/kg, single dose, IP administration: 1d 0h
|
Placebo , Multiple Dose Study
n=6 Participants
INT200-Placebo, multiple dose, IP administration: 1d 0h, 2d 0h, 2d 12h, 3d 0h, 3d 12h and 4d 0h
|
N-Rephasin® SAL200 (1.5 mg/kg), Multiple Dose Study
n=5 Participants
SAL200 1 ml (SAL-1 18 mg/mL), 1.5 mg/kg (3 mg/kg/day), Multiple dose, IP administration: 1d 0h, 2d 0h, 2d 12h, 3d 0h, 3d 12h and 4d 0h
|
N-Rephasin® SAL200 (3 mg/kg), Multiple Dose Study
SAL200 1 ml (SAL-1 18 mg/mL), 3 mg (6 mg/kg/day) , Multiple dose, IP administration: 1d 0h, 2d 0h, 2d 12h, 3d 0h, 3d 12h and 4d 0h
|
N-Rephasin® SAL200 (4.5 mg/kg), Multiple Dose Study
SAL200 1 ml (SAL-1 18 mg/mL), 4.5 mg (9 mg/kg/day), Multiple dose, IP administration: 1d 0h, 2d 0h, 2d 12h, 3d 0h, 3d 12h and 4d 0h
|
|---|---|---|---|---|---|---|
|
Pharmacodynamic Evaluation
1.5h Mean concentration of bactericidal activity (μg/mL)
|
0.38 μg/mL
Standard Deviation 0.24
|
0.14 μg/mL
Standard Deviation 0.20
|
0.22 μg/mL
Standard Deviation 0.10
|
0.20 μg/mL
Standard Deviation 0.00
|
—
|
—
|
|
Pharmacodynamic Evaluation
2h Mean concentration of bactericidal activity (μg/mL)
|
0.12 μg/mL
Standard Deviation 0.07
|
0.02 μg/mL
Standard Deviation 0.03
|
0.07 μg/mL
Standard Deviation 0.07
|
0.08 μg/mL
Standard Deviation 0.07
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 50D (±2D)Anti-drug antibody titer was assessed.
Outcome measures
| Measure |
Placebo, Single Dose Study
n=8 Participants
INT200-Placebo, single dose, IP administration: 1d 0h
|
N-Rephasin® SAL200 (6mg/kg), Single Dose Study
n=6 Participants
SAL200 1 ml (SAL-1 18 mg/mL), 6 mg/kg, single dose, IP administration: 1d 0h
|
Placebo , Multiple Dose Study
n=6 Participants
INT200-Placebo, multiple dose, IP administration: 1d 0h, 2d 0h, 2d 12h, 3d 0h, 3d 12h and 4d 0h
|
N-Rephasin® SAL200 (1.5 mg/kg), Multiple Dose Study
n=6 Participants
SAL200 1 ml (SAL-1 18 mg/mL), 1.5 mg/kg (3 mg/kg/day), Multiple dose, IP administration: 1d 0h, 2d 0h, 2d 12h, 3d 0h, 3d 12h and 4d 0h
|
N-Rephasin® SAL200 (3 mg/kg), Multiple Dose Study
n=5 Participants
SAL200 1 ml (SAL-1 18 mg/mL), 3 mg (6 mg/kg/day) , Multiple dose, IP administration: 1d 0h, 2d 0h, 2d 12h, 3d 0h, 3d 12h and 4d 0h
|
N-Rephasin® SAL200 (4.5 mg/kg), Multiple Dose Study
SAL200 1 ml (SAL-1 18 mg/mL), 4.5 mg (9 mg/kg/day), Multiple dose, IP administration: 1d 0h, 2d 0h, 2d 12h, 3d 0h, 3d 12h and 4d 0h
|
|---|---|---|---|---|---|---|
|
Immunogenicity Evaluation
ADA present at baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Immunogenicity Evaluation
ADA negative at baseline
|
8 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
5 Participants
|
—
|
|
Immunogenicity Evaluation
ADA positive post baseline (regardless of baseline)
|
0 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Immunogenicity Evaluation
ADA positive post baseline (baseline negative)
|
0 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Single administration: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours post-dose Multiple administration: the above timepoints and 25, 36, 48, 49, 60, 72, 72.25, 72.5, 72.75, 73, 73.5, 74, 75, 76, 77, 78, 80, 82, 84, 96 hours post-doseBlood sampling for PK evaluation was performed at the following time points. Summary of PK parameters after single IV administration of N-Rephasin® SAL200.
Outcome measures
| Measure |
Placebo, Single Dose Study
n=6 Participants
INT200-Placebo, single dose, IP administration: 1d 0h
|
N-Rephasin® SAL200 (6mg/kg), Single Dose Study
n=6 Participants
SAL200 1 ml (SAL-1 18 mg/mL), 6 mg/kg, single dose, IP administration: 1d 0h
|
Placebo , Multiple Dose Study
n=6 Participants
INT200-Placebo, multiple dose, IP administration: 1d 0h, 2d 0h, 2d 12h, 3d 0h, 3d 12h and 4d 0h
|
N-Rephasin® SAL200 (1.5 mg/kg), Multiple Dose Study
n=5 Participants
SAL200 1 ml (SAL-1 18 mg/mL), 1.5 mg/kg (3 mg/kg/day), Multiple dose, IP administration: 1d 0h, 2d 0h, 2d 12h, 3d 0h, 3d 12h and 4d 0h
|
N-Rephasin® SAL200 (3 mg/kg), Multiple Dose Study
SAL200 1 ml (SAL-1 18 mg/mL), 3 mg (6 mg/kg/day) , Multiple dose, IP administration: 1d 0h, 2d 0h, 2d 12h, 3d 0h, 3d 12h and 4d 0h
|
N-Rephasin® SAL200 (4.5 mg/kg), Multiple Dose Study
SAL200 1 ml (SAL-1 18 mg/mL), 4.5 mg (9 mg/kg/day), Multiple dose, IP administration: 1d 0h, 2d 0h, 2d 12h, 3d 0h, 3d 12h and 4d 0h
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic Evaluation [AUClast, AUCinf (µg*h/mL)]
AUC last
|
24.6 µg*h/mL
Standard Deviation 7.04
|
1.10 µg*h/mL
Standard Deviation 0.503
|
5.65 µg*h/mL
Standard Deviation 1.33
|
11.3 µg*h/mL
Standard Deviation 1.37
|
—
|
—
|
|
Pharmacokinetic Evaluation [AUClast, AUCinf (µg*h/mL)]
AUC inf
|
24.8 µg*h/mL
Standard Deviation 7.05
|
1.14 µg*h/mL
Standard Deviation 0.519
|
5.70 µg*h/mL
Standard Deviation 1.35
|
11.8 µg*h/mL
Standard Deviation 1.15
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Single administration: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours post-dose Multiple administration: the above timepoints and 25, 36, 48, 49, 60, 72, 72.25, 72.5, 72.75, 73, 73.5, 74, 75, 76, 77, 78, 80, 82, 84, 96 hours post-doseBlood sampling for PK evaluation was performed at the following time points. Summary of PK parameters after single IV administration of N-Rephasin® SAL200
Outcome measures
| Measure |
Placebo, Single Dose Study
n=6 Participants
INT200-Placebo, single dose, IP administration: 1d 0h
|
N-Rephasin® SAL200 (6mg/kg), Single Dose Study
n=6 Participants
SAL200 1 ml (SAL-1 18 mg/mL), 6 mg/kg, single dose, IP administration: 1d 0h
|
Placebo , Multiple Dose Study
n=6 Participants
INT200-Placebo, multiple dose, IP administration: 1d 0h, 2d 0h, 2d 12h, 3d 0h, 3d 12h and 4d 0h
|
N-Rephasin® SAL200 (1.5 mg/kg), Multiple Dose Study
n=5 Participants
SAL200 1 ml (SAL-1 18 mg/mL), 1.5 mg/kg (3 mg/kg/day), Multiple dose, IP administration: 1d 0h, 2d 0h, 2d 12h, 3d 0h, 3d 12h and 4d 0h
|
N-Rephasin® SAL200 (3 mg/kg), Multiple Dose Study
SAL200 1 ml (SAL-1 18 mg/mL), 3 mg (6 mg/kg/day) , Multiple dose, IP administration: 1d 0h, 2d 0h, 2d 12h, 3d 0h, 3d 12h and 4d 0h
|
N-Rephasin® SAL200 (4.5 mg/kg), Multiple Dose Study
SAL200 1 ml (SAL-1 18 mg/mL), 4.5 mg (9 mg/kg/day), Multiple dose, IP administration: 1d 0h, 2d 0h, 2d 12h, 3d 0h, 3d 12h and 4d 0h
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic Evaluation [Tmax, T1/2, MRTinf (h)]
Tmax (h)
|
1.00 h
Standard Deviation 1.00
|
1.00 h
Standard Deviation 1.00
|
1.00 h
Standard Deviation 1.00
|
1.00 h
Standard Deviation 1.00
|
—
|
—
|
|
Pharmacokinetic Evaluation [Tmax, T1/2, MRTinf (h)]
T1/2 (h)
|
3.38 h
Standard Deviation 3.40
|
0.386 h
Standard Deviation 0.0820
|
0.726 h
Standard Deviation 0.214
|
1.16 h
Standard Deviation 0.294
|
—
|
—
|
|
Pharmacokinetic Evaluation [Tmax, T1/2, MRTinf (h)]
MRTinf (h)
|
1.12 h
Standard Deviation 0.314
|
0.656 h
Standard Deviation 0.0760
|
0.782 h
Standard Deviation 0.596
|
0.760 h
Standard Deviation 0.0651
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Single administration: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours post-dose Multiple administration: the above timepoints and 25, 36, 48, 49, 60, 72, 72.25, 72.5, 72.75, 73, 73.5, 74, 75, 76, 77, 78, 80, 82, 84, 96 hours post-doseBlood sampling for PK evaluation was performed at the following time points. Summary of PK parameters after single IV administration of N-Rephasin® SAL200.
Outcome measures
| Measure |
Placebo, Single Dose Study
n=6 Participants
INT200-Placebo, single dose, IP administration: 1d 0h
|
N-Rephasin® SAL200 (6mg/kg), Single Dose Study
n=6 Participants
SAL200 1 ml (SAL-1 18 mg/mL), 6 mg/kg, single dose, IP administration: 1d 0h
|
Placebo , Multiple Dose Study
n=6 Participants
INT200-Placebo, multiple dose, IP administration: 1d 0h, 2d 0h, 2d 12h, 3d 0h, 3d 12h and 4d 0h
|
N-Rephasin® SAL200 (1.5 mg/kg), Multiple Dose Study
n=5 Participants
SAL200 1 ml (SAL-1 18 mg/mL), 1.5 mg/kg (3 mg/kg/day), Multiple dose, IP administration: 1d 0h, 2d 0h, 2d 12h, 3d 0h, 3d 12h and 4d 0h
|
N-Rephasin® SAL200 (3 mg/kg), Multiple Dose Study
SAL200 1 ml (SAL-1 18 mg/mL), 3 mg (6 mg/kg/day) , Multiple dose, IP administration: 1d 0h, 2d 0h, 2d 12h, 3d 0h, 3d 12h and 4d 0h
|
N-Rephasin® SAL200 (4.5 mg/kg), Multiple Dose Study
SAL200 1 ml (SAL-1 18 mg/mL), 4.5 mg (9 mg/kg/day), Multiple dose, IP administration: 1d 0h, 2d 0h, 2d 12h, 3d 0h, 3d 12h and 4d 0h
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic Evaluation [Vd (L)]
|
90.2 L
Standard Deviation 89.5
|
55.6 L
Standard Deviation 13.0
|
41.3 L
Standard Deviation 9.82
|
46.4 L
Standard Deviation 15.3
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Single administration: 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24 hours post-dose Multiple administration: the above timepoints and 25, 36, 48, 49, 60, 72, 72.25, 72.5, 72.75, 73, 73.5, 74, 75, 76, 77, 78, 80, 82, 84, 96 hours post-doseBlood sampling for PK evaluation was performed at the following time points. Summary of PK parameters after single IV administration of N-Rephasin® SAL200.
Outcome measures
| Measure |
Placebo, Single Dose Study
n=6 Participants
INT200-Placebo, single dose, IP administration: 1d 0h
|
N-Rephasin® SAL200 (6mg/kg), Single Dose Study
n=6 Participants
SAL200 1 ml (SAL-1 18 mg/mL), 6 mg/kg, single dose, IP administration: 1d 0h
|
Placebo , Multiple Dose Study
n=6 Participants
INT200-Placebo, multiple dose, IP administration: 1d 0h, 2d 0h, 2d 12h, 3d 0h, 3d 12h and 4d 0h
|
N-Rephasin® SAL200 (1.5 mg/kg), Multiple Dose Study
n=5 Participants
SAL200 1 ml (SAL-1 18 mg/mL), 1.5 mg/kg (3 mg/kg/day), Multiple dose, IP administration: 1d 0h, 2d 0h, 2d 12h, 3d 0h, 3d 12h and 4d 0h
|
N-Rephasin® SAL200 (3 mg/kg), Multiple Dose Study
SAL200 1 ml (SAL-1 18 mg/mL), 3 mg (6 mg/kg/day) , Multiple dose, IP administration: 1d 0h, 2d 0h, 2d 12h, 3d 0h, 3d 12h and 4d 0h
|
N-Rephasin® SAL200 (4.5 mg/kg), Multiple Dose Study
SAL200 1 ml (SAL-1 18 mg/mL), 4.5 mg (9 mg/kg/day), Multiple dose, IP administration: 1d 0h, 2d 0h, 2d 12h, 3d 0h, 3d 12h and 4d 0h
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic Evaluation [CL (L/h)]
|
19.0 L/h
Standard Deviation 5.63
|
107 L/h
Standard Deviation 47.1
|
40.3 L/h
Standard Deviation 5.89
|
27.4 L/h
Standard Deviation 2.96
|
—
|
—
|
Adverse Events
Placebo, Single Dose Study
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
N-Rephasin® SAL200 (6mg/kg), Single Dose Study
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo , Multiple Dose Study
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
N-Rephasin® SAL200 (1.5 mg/kg), Multiple Dose Study
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
N-Rephasin® SAL200 (3 mg/kg), Multiple Dose Study
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
N-Rephasin® SAL200 (4.5 mg/kg), Multiple Dose Study
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo, Single Dose Study
n=2 participants at risk
INT200-Placebo (N=2),single dose study
|
N-Rephasin® SAL200 (6mg/kg), Single Dose Study
n=6 participants at risk
N-Rephasin® SAL200 (6mg/kg), (N=6),single dose study
|
Placebo , Multiple Dose Study
n=6 participants at risk
INT200-Placebo (N=6),multiple dose study
|
N-Rephasin® SAL200 (1.5 mg/kg), Multiple Dose Study
n=6 participants at risk
N-Rephasin® SAL200 (1.5mg/kg), (N=6),multiple dose study
|
N-Rephasin® SAL200 (3 mg/kg), Multiple Dose Study
n=6 participants at risk
N-Rephasin® SAL200 (3mg/kg), (N=6),multiple dose study
|
N-Rephasin® SAL200 (4.5 mg/kg), Multiple Dose Study
n=6 participants at risk
N-Rephasin® SAL200 (4.5mg/kg), (N=6),multiple dose study
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/2 • Up to 50 Days after randomization.
|
16.7%
1/6 • Number of events 1 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/2 • Up to 50 Days after randomization.
|
16.7%
1/6 • Number of events 1 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
|
Gastrointestinal disorders
Odynophagia
|
50.0%
1/2 • Number of events 1 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/2 • Up to 50 Days after randomization.
|
16.7%
1/6 • Number of events 1 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/2 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
16.7%
1/6 • Number of events 1 • Up to 50 Days after randomization.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
16.7%
1/6 • Number of events 1 • Up to 50 Days after randomization.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
16.7%
1/6 • Number of events 1 • Up to 50 Days after randomization.
|
|
General disorders
Chills
|
0.00%
0/2 • Up to 50 Days after randomization.
|
66.7%
4/6 • Number of events 4 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
16.7%
1/6 • Number of events 1 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
16.7%
1/6 • Number of events 1 • Up to 50 Days after randomization.
|
|
General disorders
Pyrexia
|
0.00%
0/2 • Up to 50 Days after randomization.
|
66.7%
4/6 • Number of events 4 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
16.7%
1/6 • Number of events 1 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
|
General disorders
Hyperthermia
|
0.00%
0/2 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
16.7%
1/6 • Number of events 1 • Up to 50 Days after randomization.
|
|
General disorders
Infusion site erythema
|
0.00%
0/2 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
33.3%
2/6 • Number of events 2 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
|
General disorders
Infusion site induration
|
0.00%
0/2 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
16.7%
1/6 • Number of events 1 • Up to 50 Days after randomization.
|
16.7%
1/6 • Number of events 1 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
|
General disorders
Infusion site pain
|
0.00%
0/2 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
33.3%
2/6 • Number of events 2 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
16.7%
1/6 • Number of events 1 • Up to 50 Days after randomization.
|
|
General disorders
Infusion site warmth
|
0.00%
0/2 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
16.7%
1/6 • Number of events 1 • Up to 50 Days after randomization.
|
|
General disorders
Injection site induration
|
0.00%
0/2 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
16.7%
1/6 • Number of events 1 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
|
Injury, poisoning and procedural complications
Ligament pain
|
0.00%
0/2 • Up to 50 Days after randomization.
|
16.7%
1/6 • Number of events 1 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/2 • Up to 50 Days after randomization.
|
83.3%
5/6 • Number of events 5 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
33.3%
2/6 • Number of events 2 • Up to 50 Days after randomization.
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • Up to 50 Days after randomization.
|
50.0%
3/6 • Number of events 3 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
16.7%
1/6 • Number of events 1 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
16.7%
1/6 • Number of events 1 • Up to 50 Days after randomization.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/2 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
16.7%
1/6 • Number of events 1 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
1/2 • Number of events 1 • Up to 50 Days after randomization.
|
16.7%
1/6 • Number of events 1 • Up to 50 Days after randomization.
|
16.7%
1/6 • Number of events 1 • Up to 50 Days after randomization.
|
16.7%
1/6 • Number of events 1 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
16.7%
1/6 • Number of events 1 • Up to 50 Days after randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/2 • Up to 50 Days after randomization.
|
16.7%
1/6 • Number of events 1 • Up to 50 Days after randomization.
|
16.7%
1/6 • Number of events 1 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
50.0%
1/2 • Number of events 1 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
16.7%
1/6 • Number of events 1 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
16.7%
1/6 • Number of events 1 • Up to 50 Days after randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
50.0%
1/2 • Number of events 1 • Up to 50 Days after randomization.
|
33.3%
2/6 • Number of events 2 • Up to 50 Days after randomization.
|
16.7%
1/6 • Number of events 1 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/2 • Up to 50 Days after randomization.
|
16.7%
1/6 • Number of events 1 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
16.7%
1/6 • Number of events 1 • Up to 50 Days after randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/2 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
0.00%
0/6 • Up to 50 Days after randomization.
|
16.7%
1/6 • Number of events 1 • Up to 50 Days after randomization.
|
Additional Information
Jun SooYoun, Ph.D. / Executive Director/ Principal researcher
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