Trial Outcomes & Findings for A Clinical Study to Evaluate the Safety of CS-1103 in Healthy Participants (NCT NCT06316973)
NCT ID: NCT06316973
Last Updated: 2025-11-10
Results Overview
Treatment-emergent adverse events assessed through physical examinations, vital signs (blood pressure, pulse rate, respiratory rate, oxygen saturation, and body temperature), electrocardiograms (digital 12-lead electrocardiograms (ECGs). Any correlation between CS-1103 plasma concentrations and changes in QT intervals will be noted), and laboratory parameters (clinical chemistry, hematology, coagulation, and urinalysis).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
3 days plus 8 days for follow-up
Results posted on
2025-11-10
Participant Flow
Participant milestones
| Measure |
Cohort 1 (2.5 mg/kg CS-1103 [Free Acid])
6 participants received a single dose of 2.7 mg/kg (2.5 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes.
A diluted CS-1103 saline solution in an IV bag is used for drug administration.
|
Cohort 2 (7.5 mg/kg CS-1103 [Free Acid])
6 participants received single dose of 8.0 mg/kg (7.5 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes.
A diluted CS-1103 saline solution in an IV bag is used for drug administration.
|
Cohort 3 (15.1 mg/kg CS-1103 [Free Acid])
6 participants received a single dose of 16.0 mg/kg (15.1 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes.
A diluted CS-1103 saline solution in an IV bag is used for drug administration.
|
Cohort 4 (17.9 mg/kg CS-1103 [Free Acid])
6 participants received a single dose of 19.0 mg/kg (17.9 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes.
A diluted CS-1103 saline solution in an IV bag is used for drug administration.
|
Placebo
2 participants for each cohort were administered with placebo.
Total administered volume of saline matched administered volume for the corresponding CS-1103 solution in each cohort.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
8
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Clinical Study to Evaluate the Safety of CS-1103 in Healthy Participants
Baseline characteristics by cohort
| Measure |
Cohort 1 (2.5 mg/kg CS-1103 [Free Acid])
n=6 Participants
6 participants received a single dose of 2.7 mg/kg (2.5 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes.
A diluted CS-1103 saline solution in an IV bag is used for drug administration.
|
Cohort 2 (7.5 mg/kg CS-1103 [Free Acid])
n=6 Participants
6 participants received single dose of 8.0 mg/kg (7.5 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes.
A diluted CS-1103 saline solution in an IV bag is used for drug administration.
|
Cohort 3 (15.1 mg/kg CS-1103 [Free Acid])
n=6 Participants
6 participants received a single dose of 16.0 mg/kg (15.1 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes.
A diluted CS-1103 saline solution in an IV bag is used for drug administration.
|
Cohort 4 (17.9 mg/kg CS-1103 [Free Acid])
n=6 Participants
6 participants received a single dose of 19.0 mg/kg (17.9 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes.
A diluted CS-1103 saline solution in an IV bag is used for drug administration.
|
Placebo
n=8 Participants
2 participants for each cohort were administered with placebo.
Total administered volume of saline matched administered volume for the corresponding CS-1103 solution in each cohort.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=46 Participants
|
4 Participants
n=34 Participants
|
|
Age, Continuous
|
29.7 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
30.3 years
STANDARD_DEVIATION 8.3 • n=20 Participants
|
39.5 years
STANDARD_DEVIATION 9.0 • n=40 Participants
|
38.5 years
STANDARD_DEVIATION 7.9 • n=28 Participants
|
36.3 years
STANDARD_DEVIATION 10.4 • n=46 Participants
|
34.9 years
STANDARD_DEVIATION 9.7 • n=34 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
6 Participants
n=28 Participants
|
8 Participants
n=46 Participants
|
28 Participants
n=34 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
2 Participants
n=28 Participants
|
0 Participants
n=46 Participants
|
4 Participants
n=34 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
4 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
4 Participants
n=28 Participants
|
8 Participants
n=46 Participants
|
28 Participants
n=34 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=34 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=34 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=34 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=34 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
4 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
2 Participants
n=28 Participants
|
6 Participants
n=46 Participants
|
18 Participants
n=34 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
2 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
4 Participants
n=28 Participants
|
2 Participants
n=46 Participants
|
13 Participants
n=34 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=46 Participants
|
1 Participants
n=34 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=34 Participants
|
|
BMI
|
25.815 kg/m^2
STANDARD_DEVIATION 2.479 • n=5 Participants
|
24.728 kg/m^2
STANDARD_DEVIATION 3.451 • n=20 Participants
|
24.528 kg/m^2
STANDARD_DEVIATION 2.731 • n=40 Participants
|
25.975 kg/m^2
STANDARD_DEVIATION 2.602 • n=28 Participants
|
26.161 kg/m^2
STANDARD_DEVIATION 2.308 • n=46 Participants
|
25.487 kg/m^2
STANDARD_DEVIATION 2.624 • n=34 Participants
|
|
Weight
|
83.30 kg
STANDARD_DEVIATION 11.81 • n=5 Participants
|
72.97 kg
STANDARD_DEVIATION 8.30 • n=20 Participants
|
68.32 kg
STANDARD_DEVIATION 6.93 • n=40 Participants
|
76.20 kg
STANDARD_DEVIATION 9.27 • n=28 Participants
|
79.44 kg
STANDARD_DEVIATION 6.77 • n=46 Participants
|
76.26 kg
STANDARD_DEVIATION 9.60 • n=34 Participants
|
|
Height
|
179.23 cm
STANDARD_DEVIATION 6.59 • n=5 Participants
|
170.80 cm
STANDARD_DEVIATION 10.11 • n=20 Participants
|
166.97 cm
STANDARD_DEVIATION 6.65 • n=40 Participants
|
171.12 cm
STANDARD_DEVIATION 5.98 • n=28 Participants
|
174.63 cm
STANDARD_DEVIATION 5.42 • n=46 Participants
|
172.68 cm
STANDARD_DEVIATION 7.73 • n=34 Participants
|
PRIMARY outcome
Timeframe: 3 days plus 8 days for follow-upTreatment-emergent adverse events assessed through physical examinations, vital signs (blood pressure, pulse rate, respiratory rate, oxygen saturation, and body temperature), electrocardiograms (digital 12-lead electrocardiograms (ECGs). Any correlation between CS-1103 plasma concentrations and changes in QT intervals will be noted), and laboratory parameters (clinical chemistry, hematology, coagulation, and urinalysis).
Outcome measures
| Measure |
Cohort 4 (17.9 mg/kg CS-1103 [Free Acid])
n=6 Participants
6 participants received a single dose of 19.0 mg/kg (17.9 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes.
A diluted CS-1103 saline solution in an IV bag is used for drug administration.
|
Cohort 1 (2.5 mg/kg CS-1103 [Free Acid])
n=6 Participants
6 participants received a single dose of 2.7 mg/kg (2.5 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes.
A diluted CS-1103 saline solution in an IV bag is used for drug administration.
|
Cohort 2 (7.5 mg/kg CS-1103 [Free Acid])
n=6 Participants
6 participants received single dose of 8.0 mg/kg (7.5 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes.
A diluted CS-1103 saline solution in an IV bag is used for drug administration.
|
Cohort 3 (15.1 mg/kg CS-1103 [Free Acid])
n=6 Participants
6 participants received a single dose of 16.0 mg/kg (15.1 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes.
A diluted CS-1103 saline solution in an IV bag is used for drug administration.
|
Placebo
n=8 Participants
2 participants for each cohort were administered with placebo. Total administered volume of saline matched administered volume for the corresponding CS-1103 solution in each cohort.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs)
TEAEs
|
4 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs)
TEAEs leading to study discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs)
Serious TEAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs)
TEAEs leading to death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs)
Related TEAEs
|
4 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 3 days plus 8 days for follow-upSeverity of AEs was classified as mild, moderate, or severe (increasing severity). A subject experiencing multiple occurrences of an adverse event in a particular category was counted, at most, once for that category for each treatment.
Outcome measures
| Measure |
Cohort 4 (17.9 mg/kg CS-1103 [Free Acid])
n=6 Participants
6 participants received a single dose of 19.0 mg/kg (17.9 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes.
A diluted CS-1103 saline solution in an IV bag is used for drug administration.
|
Cohort 1 (2.5 mg/kg CS-1103 [Free Acid])
n=6 Participants
6 participants received a single dose of 2.7 mg/kg (2.5 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes.
A diluted CS-1103 saline solution in an IV bag is used for drug administration.
|
Cohort 2 (7.5 mg/kg CS-1103 [Free Acid])
n=6 Participants
6 participants received single dose of 8.0 mg/kg (7.5 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes.
A diluted CS-1103 saline solution in an IV bag is used for drug administration.
|
Cohort 3 (15.1 mg/kg CS-1103 [Free Acid])
n=6 Participants
6 participants received a single dose of 16.0 mg/kg (15.1 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes.
A diluted CS-1103 saline solution in an IV bag is used for drug administration.
|
Placebo
n=8 Participants
2 participants for each cohort were administered with placebo. Total administered volume of saline matched administered volume for the corresponding CS-1103 solution in each cohort.
|
|---|---|---|---|---|---|
|
Number of Participants by Severity of AEs
Mild
|
4 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants by Severity of AEs
Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants by Severity of AEs
Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: End-of-Infusion (EOI), 5, 10, 20, 30, 40 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 hrMaximum concentration, obtained directly from the observed concentration versus time data.
Outcome measures
| Measure |
Cohort 4 (17.9 mg/kg CS-1103 [Free Acid])
n=6 Participants
6 participants received a single dose of 19.0 mg/kg (17.9 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes.
A diluted CS-1103 saline solution in an IV bag is used for drug administration.
|
Cohort 1 (2.5 mg/kg CS-1103 [Free Acid])
n=6 Participants
6 participants received a single dose of 2.7 mg/kg (2.5 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes.
A diluted CS-1103 saline solution in an IV bag is used for drug administration.
|
Cohort 2 (7.5 mg/kg CS-1103 [Free Acid])
n=6 Participants
6 participants received single dose of 8.0 mg/kg (7.5 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes.
A diluted CS-1103 saline solution in an IV bag is used for drug administration.
|
Cohort 3 (15.1 mg/kg CS-1103 [Free Acid])
n=6 Participants
6 participants received a single dose of 16.0 mg/kg (15.1 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes.
A diluted CS-1103 saline solution in an IV bag is used for drug administration.
|
Placebo
2 participants for each cohort were administered with placebo. Total administered volume of saline matched administered volume for the corresponding CS-1103 solution in each cohort.
|
|---|---|---|---|---|---|
|
Plasma Pharmacokinetic (PK) Parameter: Cmax
|
176.0 μg/mL
Geometric Coefficient of Variation 17.9
|
20.78 μg/mL
Geometric Coefficient of Variation 31.3
|
58.25 μg/mL
Geometric Coefficient of Variation 17.7
|
156.9 μg/mL
Geometric Coefficient of Variation 24.8
|
—
|
SECONDARY outcome
Timeframe: End-of-Infusion (EOI), 5, 10, 20, 30, 40 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 hrTime of maximum observed blood plasma concentration (Cmax) of CS-1103
Outcome measures
| Measure |
Cohort 4 (17.9 mg/kg CS-1103 [Free Acid])
n=5 Participants
6 participants received a single dose of 19.0 mg/kg (17.9 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes.
A diluted CS-1103 saline solution in an IV bag is used for drug administration.
|
Cohort 1 (2.5 mg/kg CS-1103 [Free Acid])
n=6 Participants
6 participants received a single dose of 2.7 mg/kg (2.5 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes.
A diluted CS-1103 saline solution in an IV bag is used for drug administration.
|
Cohort 2 (7.5 mg/kg CS-1103 [Free Acid])
n=5 Participants
6 participants received single dose of 8.0 mg/kg (7.5 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes.
A diluted CS-1103 saline solution in an IV bag is used for drug administration.
|
Cohort 3 (15.1 mg/kg CS-1103 [Free Acid])
n=6 Participants
6 participants received a single dose of 16.0 mg/kg (15.1 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes.
A diluted CS-1103 saline solution in an IV bag is used for drug administration.
|
Placebo
2 participants for each cohort were administered with placebo. Total administered volume of saline matched administered volume for the corresponding CS-1103 solution in each cohort.
|
|---|---|---|---|---|---|
|
Plasma PK Parameter: Tmax
|
0.180 hours
Interval 0.18 to 0.25
|
0.235 hours
Interval 0.18 to 0.27
|
0.180 hours
Interval 0.18 to 0.33
|
0.180 hours
Interval 0.18 to 0.33
|
—
|
SECONDARY outcome
Timeframe: End-of-Infusion (EOI), 5, 10, 20, 30, 40 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 hrTerminal Elimination Half-life of CS-1103
Outcome measures
| Measure |
Cohort 4 (17.9 mg/kg CS-1103 [Free Acid])
n=6 Participants
6 participants received a single dose of 19.0 mg/kg (17.9 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes.
A diluted CS-1103 saline solution in an IV bag is used for drug administration.
|
Cohort 1 (2.5 mg/kg CS-1103 [Free Acid])
n=6 Participants
6 participants received a single dose of 2.7 mg/kg (2.5 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes.
A diluted CS-1103 saline solution in an IV bag is used for drug administration.
|
Cohort 2 (7.5 mg/kg CS-1103 [Free Acid])
n=6 Participants
6 participants received single dose of 8.0 mg/kg (7.5 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes.
A diluted CS-1103 saline solution in an IV bag is used for drug administration.
|
Cohort 3 (15.1 mg/kg CS-1103 [Free Acid])
n=6 Participants
6 participants received a single dose of 16.0 mg/kg (15.1 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes.
A diluted CS-1103 saline solution in an IV bag is used for drug administration.
|
Placebo
2 participants for each cohort were administered with placebo. Total administered volume of saline matched administered volume for the corresponding CS-1103 solution in each cohort.
|
|---|---|---|---|---|---|
|
Plasma PK Parameter: t1/2
|
4.558 hours
Geometric Coefficient of Variation 19.9
|
4.323 hours
Geometric Coefficient of Variation 26.4
|
4.118 hours
Geometric Coefficient of Variation 13.7
|
4.215 hours
Geometric Coefficient of Variation 17.4
|
—
|
SECONDARY outcome
Timeframe: End-of-Infusion (EOI), 5, 10, 20, 30, 40 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 hrSystemic Clearance of CS-1103
Outcome measures
| Measure |
Cohort 4 (17.9 mg/kg CS-1103 [Free Acid])
n=5 Participants
6 participants received a single dose of 19.0 mg/kg (17.9 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes.
A diluted CS-1103 saline solution in an IV bag is used for drug administration.
|
Cohort 1 (2.5 mg/kg CS-1103 [Free Acid])
n=6 Participants
6 participants received a single dose of 2.7 mg/kg (2.5 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes.
A diluted CS-1103 saline solution in an IV bag is used for drug administration.
|
Cohort 2 (7.5 mg/kg CS-1103 [Free Acid])
n=5 Participants
6 participants received single dose of 8.0 mg/kg (7.5 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes.
A diluted CS-1103 saline solution in an IV bag is used for drug administration.
|
Cohort 3 (15.1 mg/kg CS-1103 [Free Acid])
n=6 Participants
6 participants received a single dose of 16.0 mg/kg (15.1 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes.
A diluted CS-1103 saline solution in an IV bag is used for drug administration.
|
Placebo
2 participants for each cohort were administered with placebo. Total administered volume of saline matched administered volume for the corresponding CS-1103 solution in each cohort.
|
|---|---|---|---|---|---|
|
Plasma PK Parameter: CL
|
0.05040 L/h
Geometric Coefficient of Variation 17.3
|
0.04915 L/h
Geometric Coefficient of Variation 24.2
|
0.04971 L/h
Geometric Coefficient of Variation 16.1
|
0.04762 L/h
Geometric Coefficient of Variation 20.6
|
—
|
SECONDARY outcome
Timeframe: End-of-Infusion (EOI), 5, 10, 20, 30, 40 min, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 hrVolume of Distribution of CS-1103
Outcome measures
| Measure |
Cohort 4 (17.9 mg/kg CS-1103 [Free Acid])
n=5 Participants
6 participants received a single dose of 19.0 mg/kg (17.9 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes.
A diluted CS-1103 saline solution in an IV bag is used for drug administration.
|
Cohort 1 (2.5 mg/kg CS-1103 [Free Acid])
n=6 Participants
6 participants received a single dose of 2.7 mg/kg (2.5 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes.
A diluted CS-1103 saline solution in an IV bag is used for drug administration.
|
Cohort 2 (7.5 mg/kg CS-1103 [Free Acid])
n=5 Participants
6 participants received single dose of 8.0 mg/kg (7.5 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes.
A diluted CS-1103 saline solution in an IV bag is used for drug administration.
|
Cohort 3 (15.1 mg/kg CS-1103 [Free Acid])
n=6 Participants
6 participants received a single dose of 16.0 mg/kg (15.1 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes.
A diluted CS-1103 saline solution in an IV bag is used for drug administration.
|
Placebo
2 participants for each cohort were administered with placebo. Total administered volume of saline matched administered volume for the corresponding CS-1103 solution in each cohort.
|
|---|---|---|---|---|---|
|
Plasma PK Parameter: Vz
|
0.3273 L
Geometric Coefficient of Variation 24.0
|
0.3065 L
Geometric Coefficient of Variation 15.0
|
0.2953 L
Geometric Coefficient of Variation 7.8
|
0.2896 L
Geometric Coefficient of Variation 12.0
|
—
|
SECONDARY outcome
Timeframe: Time intervals from 0-24 hours after IV administration of CS-1103Cumulative fraction of dose excreted in urine during the pooled collection intervals. Due to inherent error in measuring CS-1103 recovered in urine, the calculated recovery may exceed 100% of the dose.
Outcome measures
| Measure |
Cohort 4 (17.9 mg/kg CS-1103 [Free Acid])
n=6 Participants
6 participants received a single dose of 19.0 mg/kg (17.9 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes.
A diluted CS-1103 saline solution in an IV bag is used for drug administration.
|
Cohort 1 (2.5 mg/kg CS-1103 [Free Acid])
n=6 Participants
6 participants received a single dose of 2.7 mg/kg (2.5 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes.
A diluted CS-1103 saline solution in an IV bag is used for drug administration.
|
Cohort 2 (7.5 mg/kg CS-1103 [Free Acid])
n=6 Participants
6 participants received single dose of 8.0 mg/kg (7.5 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes.
A diluted CS-1103 saline solution in an IV bag is used for drug administration.
|
Cohort 3 (15.1 mg/kg CS-1103 [Free Acid])
n=6 Participants
6 participants received a single dose of 16.0 mg/kg (15.1 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes.
A diluted CS-1103 saline solution in an IV bag is used for drug administration.
|
Placebo
2 participants for each cohort were administered with placebo. Total administered volume of saline matched administered volume for the corresponding CS-1103 solution in each cohort.
|
|---|---|---|---|---|---|
|
Urine PK Parameter: Fe (0-last)
|
98.70 percentage of dose administered
Standard Deviation 9.129
|
91.58 percentage of dose administered
Standard Deviation 12.37
|
108.3 percentage of dose administered
Standard Deviation 4.227
|
101.0 percentage of dose administered
Standard Deviation 5.433
|
—
|
Adverse Events
Cohort 1 (2.5 mg/kg CS-1103 [Free Acid])
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 2 (7.5 mg/kg CS-1103 [Free Acid])
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 3 (15.1 mg/kg CS-1103 [Free Acid])
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 4 (17.9 mg/kg CS-1103 [Free Acid])
Serious events: 0 serious events
Other events: 4 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
| Measure |
Cohort 1 (2.5 mg/kg CS-1103 [Free Acid])
n=6 participants at risk
6 participants received a single dose of 2.7 mg/kg (2.5 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes.
A diluted CS-1103 saline solution in an IV bag is used for drug administration.
|
Cohort 2 (7.5 mg/kg CS-1103 [Free Acid])
n=6 participants at risk
6 participants received single dose of 8.0 mg/kg (7.5 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes.
A diluted CS-1103 saline solution in an IV bag is used for drug administration.
|
Cohort 3 (15.1 mg/kg CS-1103 [Free Acid])
n=6 participants at risk
6 participants received a single dose of 16.0 mg/kg (15.1 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes.
A diluted CS-1103 saline solution in an IV bag is used for drug administration.
|
Cohort 4 (17.9 mg/kg CS-1103 [Free Acid])
n=6 participants at risk
6 participants received a single dose of 19.0 mg/kg (17.9 mg/kg free acid) CS-1103 administered as solution for infusion by IV over 10 minutes.
A diluted CS-1103 saline solution in an IV bag is used for drug administration.
|
Placebo
n=8 participants at risk
2 participants for each cohort were administered with placebo. Total administered volume of saline matched administered volume for the corresponding CS-1103 solution in each cohort.
|
|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Blood creatine phosphokinase increased
|
16.7%
1/6 • 3 days plus 8 days for follow-up
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
0.00%
0/8 • 3 days plus 8 days for follow-up
|
|
Injury, poisoning and procedural complications
Blood creatinine increased
|
16.7%
1/6 • 3 days plus 8 days for follow-up
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
0.00%
0/8 • 3 days plus 8 days for follow-up
|
|
Injury, poisoning and procedural complications
Blood lactate dehydrogenase increased
|
16.7%
1/6 • 3 days plus 8 days for follow-up
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
0.00%
0/8 • 3 days plus 8 days for follow-up
|
|
Injury, poisoning and procedural complications
Glomerular filtration rate decreased
|
16.7%
1/6 • 3 days plus 8 days for follow-up
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
0.00%
0/8 • 3 days plus 8 days for follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
33.3%
2/6 • 3 days plus 8 days for follow-up
|
0.00%
0/8 • 3 days plus 8 days for follow-up
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
16.7%
1/6 • 3 days plus 8 days for follow-up
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
0.00%
0/8 • 3 days plus 8 days for follow-up
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
16.7%
1/6 • 3 days plus 8 days for follow-up
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
0.00%
0/8 • 3 days plus 8 days for follow-up
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
16.7%
1/6 • 3 days plus 8 days for follow-up
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
0.00%
0/8 • 3 days plus 8 days for follow-up
|
|
Vascular disorders
Flushing
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
16.7%
1/6 • 3 days plus 8 days for follow-up
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
0.00%
0/8 • 3 days plus 8 days for follow-up
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
16.7%
1/6 • 3 days plus 8 days for follow-up
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
0.00%
0/8 • 3 days plus 8 days for follow-up
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
16.7%
1/6 • 3 days plus 8 days for follow-up
|
33.3%
2/6 • 3 days plus 8 days for follow-up
|
0.00%
0/8 • 3 days plus 8 days for follow-up
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
16.7%
1/6 • 3 days plus 8 days for follow-up
|
0.00%
0/8 • 3 days plus 8 days for follow-up
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
16.7%
1/6 • 3 days plus 8 days for follow-up
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
0.00%
0/8 • 3 days plus 8 days for follow-up
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • 3 days plus 8 days for follow-up
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
0.00%
0/8 • 3 days plus 8 days for follow-up
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
16.7%
1/6 • 3 days plus 8 days for follow-up
|
0.00%
0/8 • 3 days plus 8 days for follow-up
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
16.7%
1/6 • 3 days plus 8 days for follow-up
|
0.00%
0/8 • 3 days plus 8 days for follow-up
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
16.7%
1/6 • 3 days plus 8 days for follow-up
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
0.00%
0/8 • 3 days plus 8 days for follow-up
|
|
Injury, poisoning and procedural complications
Alanine aminotransferase increased
|
16.7%
1/6 • 3 days plus 8 days for follow-up
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
0.00%
0/8 • 3 days plus 8 days for follow-up
|
|
Injury, poisoning and procedural complications
Aspartate aminotransferase increased
|
16.7%
1/6 • 3 days plus 8 days for follow-up
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
0.00%
0/8 • 3 days plus 8 days for follow-up
|
|
Cardiac disorders
Palpitations
|
16.7%
1/6 • 3 days plus 8 days for follow-up
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
0.00%
0/6 • 3 days plus 8 days for follow-up
|
0.00%
0/8 • 3 days plus 8 days for follow-up
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place