Trial Outcomes & Findings for Safety Study of Efprezimod Alfa (CD24Fc, MK-7110) When Administered Intravenously in Healthy Adult Subjects (MK-7110-001) (NCT NCT02650895)
NCT ID: NCT02650895
Last Updated: 2023-01-12
Results Overview
List of adverse events in the form of frequency and grade. Assessment of safety based primarily on the frequency and nature of adverse events, clinical laboratory assessments (chemistry, hematology, and urinalysis), physical examinations, vital signs, 12-lead ECGs, and telemetry monitoring from pre-dosing to day 42 visits. The data include all treatment-emergent adverse events (TEAEs) including specific drug-related TEAEs.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
Up to 42 days after treatment
Results posted on
2023-01-12
Participant Flow
Study Period: 32 weeks. Initiation Date: 02 June 2014. Completion Date: 15 January 2015. Study site: Clinical Pharmacology Unit, Medpace Inc. Cincinnati, Ohio.
Diagnosis and Main Criteria for Inclusion: The population for this study was healthy males and females between the ages of 18 and 55 years, inclusive, in good health based on medical history, physical examination, electrocardiogram (ECG), and routine laboratory tests, with a body mass index between 18 kg/m2 and 30 kg/m2, inclusive.
Participant milestones
| Measure |
Saline
Single dose of 100 ml normal saline is administrated as intravenous infusion in one hour. Saline: 0.9% sodium chloride
|
CD24Fc 10 mg
Single dose of 10 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
|
CD24Fc 30 mg
Single dose of 30 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
|
CD24Fc 60 mg
Single dose of 60 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
|
CD24Fc 120 mg
Single dose of 120 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
|
CD24Fc 240 mg
Single dose of 240 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
6
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
10
|
5
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Saline
Single dose of 100 ml normal saline is administrated as intravenous infusion in one hour. Saline: 0.9% sodium chloride
|
CD24Fc 10 mg
Single dose of 10 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
|
CD24Fc 30 mg
Single dose of 30 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
|
CD24Fc 60 mg
Single dose of 60 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
|
CD24Fc 120 mg
Single dose of 120 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
|
CD24Fc 240 mg
Single dose of 240 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Safety Study of Efprezimod Alfa (CD24Fc, MK-7110) When Administered Intravenously in Healthy Adult Subjects (MK-7110-001)
Baseline characteristics by cohort
| Measure |
Saline
n=10 Participants
Single dose of 100 ml normal saline is administrated as intravenous infusion in one hour. Saline: 0.9% sodium chloride
|
CD24Fc 10 mg
n=6 Participants
Single dose of 10 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
|
CD24Fc 30 mg
n=6 Participants
Single dose of 30 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
|
CD24Fc 60 mg
n=6 Participants
Single dose of 60 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
|
CD24Fc 120 mg
n=6 Participants
Single dose of 120 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
|
CD24Fc 240 mg
n=6 Participants
Single dose of 240 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
33.8 years
STANDARD_DEVIATION 9.87 • n=5 Participants
|
33.2 years
STANDARD_DEVIATION 6.65 • n=7 Participants
|
30.0 years
STANDARD_DEVIATION 11.37 • n=5 Participants
|
33.5 years
STANDARD_DEVIATION 7.71 • n=4 Participants
|
43.3 years
STANDARD_DEVIATION 9.40 • n=21 Participants
|
35.5 years
STANDARD_DEVIATION 7.77 • n=10 Participants
|
34.8 years
STANDARD_DEVIATION 9.34 • n=115 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
17 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
23 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
38 Participants
n=115 Participants
|
|
Ethnicity (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=10 Participants
|
0 Participants
n=115 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=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
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
|
1 Participants
n=10 Participants
|
1 Participants
n=115 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=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
28 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
10 Participants
n=115 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=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
6 participants
n=21 Participants
|
6 participants
n=10 Participants
|
40 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Up to 42 days after treatmentPopulation: The analysis population included all participants who received at least one dose of study medication.
List of adverse events in the form of frequency and grade. Assessment of safety based primarily on the frequency and nature of adverse events, clinical laboratory assessments (chemistry, hematology, and urinalysis), physical examinations, vital signs, 12-lead ECGs, and telemetry monitoring from pre-dosing to day 42 visits. The data include all treatment-emergent adverse events (TEAEs) including specific drug-related TEAEs.
Outcome measures
| Measure |
Saline
n=10 Participants
Single dose of 100 ml normal saline is administrated as intravenous infusion in one hour. Saline: 0.9% sodium chloride
|
CD24Fc 10 mg
n=6 Participants
Single dose of 10 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
|
CD24Fc 30 mg
n=6 Participants
Single dose of 30 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
|
CD24Fc 60 mg
n=6 Participants
Single dose of 60 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
|
CD24Fc 120 mg
n=6 Participants
Single dose of 120 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
|
CD24Fc 240 mg
n=6 Participants
Single dose of 240 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
|
|---|---|---|---|---|---|---|
|
Assessment of Safety Based Primarily on the Frequency and Nature of Adverse Events, Clinical Laboratory Assessments (Chemistry, Hematology, and Urinalysis), Physical Examinations, Vital Signs, 12-lead Electrocardiograms (ECGs), and Telemetry Monitoring
Subjects without any drug-related TEAE
|
9 Participants
|
4 Participants
|
5 Participants
|
5 Participants
|
6 Participants
|
6 Participants
|
|
Assessment of Safety Based Primarily on the Frequency and Nature of Adverse Events, Clinical Laboratory Assessments (Chemistry, Hematology, and Urinalysis), Physical Examinations, Vital Signs, 12-lead Electrocardiograms (ECGs), and Telemetry Monitoring
Nervous system disorders: Headache
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Assessment of Safety Based Primarily on the Frequency and Nature of Adverse Events, Clinical Laboratory Assessments (Chemistry, Hematology, and Urinalysis), Physical Examinations, Vital Signs, 12-lead Electrocardiograms (ECGs), and Telemetry Monitoring
Cardiac disorders: Ventricular tachycardia
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 42 days after treatmentPopulation: The analysis population included all participants who received at least one dose of study medication and who had evaluable concentration data for CD24Fc.
Measurement of serum CD24Fc concentration at different time points after administration.
Outcome measures
| Measure |
Saline
n=6 Participants
Single dose of 100 ml normal saline is administrated as intravenous infusion in one hour. Saline: 0.9% sodium chloride
|
CD24Fc 10 mg
n=6 Participants
Single dose of 10 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
|
CD24Fc 30 mg
n=6 Participants
Single dose of 30 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
|
CD24Fc 60 mg
n=6 Participants
Single dose of 60 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
|
CD24Fc 120 mg
n=6 Participants
Single dose of 120 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
|
CD24Fc 240 mg
Single dose of 240 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
|
|---|---|---|---|---|---|---|
|
Serum Concentration of CD24Fc Over Time
Pre-dose
|
12.8 ng/ml
Standard Deviation 31.36
|
9.2 ng/ml
Standard Deviation 22.49
|
25.7 ng/ml
Standard Deviation 44.48
|
0.0 ng/ml
Standard Deviation 0.00
|
0.0 ng/ml
Standard Deviation 0.00
|
—
|
|
Serum Concentration of CD24Fc Over Time
1 hour post-dose
|
2464.7 ng/ml
Standard Deviation 571.94
|
9715.9 ng/ml
Standard Deviation 1716.63
|
30082.5 ng/ml
Standard Deviation 7178.61
|
49491.7 ng/ml
Standard Deviation 8113.51
|
94091.3 ng/ml
Standard Deviation 13576.66
|
—
|
|
Serum Concentration of CD24Fc Over Time
2 hours post-dose
|
2245.3 ng/ml
Standard Deviation 527.14
|
8566.7 ng/ml
Standard Deviation 1037.74
|
25178.0 ng/ml
Standard Deviation 6339.22
|
49598.0 ng/ml
Standard Deviation 11087.03
|
87735.2 ng/ml
Standard Deviation 13424.35
|
—
|
|
Serum Concentration of CD24Fc Over Time
12 hours post-dose
|
1680.6 ng/ml
Standard Deviation 191.57
|
5842.6 ng/ml
Standard Deviation 612.76
|
17068.8 ng/ml
Standard Deviation 4353.50
|
26906.5 ng/ml
Standard Deviation 7418.39
|
55358.3 ng/ml
Standard Deviation 10202.10
|
—
|
|
Serum Concentration of CD24Fc Over Time
24 hours post-dose
|
1506.0 ng/ml
Standard Deviation 279.92
|
5251.0 ng/ml
Standard Deviation 449.67
|
14109.8 ng/ml
Standard Deviation 4335.70
|
25874.5 ng/ml
Standard Deviation 7187.38
|
46554.7 ng/ml
Standard Deviation 7213.90
|
—
|
|
Serum Concentration of CD24Fc Over Time
72 hours post-dose
|
996.1 ng/ml
Standard Deviation 259.34
|
3615.6 ng/ml
Standard Deviation 538.01
|
9792.5 ng/ml
Standard Deviation 1186.99
|
15552.3 ng/ml
Standard Deviation 4930.29
|
31793.7 ng/ml
Standard Deviation 4360.83
|
—
|
|
Serum Concentration of CD24Fc Over Time
Day 7
|
754.4 ng/ml
Standard Deviation 183.84
|
1941.5 ng/ml
Standard Deviation 138.83
|
6585.3 ng/ml
Standard Deviation 2861.77
|
11649.3 ng/ml
Standard Deviation 4299.71
|
21963.5 ng/ml
Standard Deviation 3042.93
|
—
|
|
Serum Concentration of CD24Fc Over Time
Day 14
|
419.5 ng/ml
Standard Deviation 112.20
|
1261.8 ng/ml
Standard Deviation 108.92
|
2712.6 ng/ml
Standard Deviation 762.02
|
7336.7 ng/ml
Standard Deviation 2552.98
|
13083.8 ng/ml
Standard Deviation 2081.62
|
—
|
|
Serum Concentration of CD24Fc Over Time
Day 28
|
218.5 ng/ml
Standard Deviation 69.86
|
672.3 ng/ml
Standard Deviation 80.26
|
1199.6 ng/ml
Standard Deviation 298.24
|
2969.4 ng/ml
Standard Deviation 1251.53
|
6162.3 ng/ml
Standard Deviation 909.27
|
—
|
|
Serum Concentration of CD24Fc Over Time
Day 42
|
87.3 ng/ml
Standard Deviation 35.07
|
315.0 ng/ml
Standard Deviation 73.96
|
643.5 ng/ml
Standard Deviation 244.95
|
1563.8 ng/ml
Standard Deviation 641.24
|
2799.3 ng/ml
Standard Deviation 463.22
|
—
|
SECONDARY outcome
Timeframe: Up to 42 days after treatmentPopulation: The analysis population included all participants who received at least one dose of study medication and who had evaluable pharmacokinetic Cmax data for CD24Fc.
Assessment of CD24Fc pharmacokinetics based on serum CD24Fc concentration at different time points after administration to determine drug Cmax. Cmax was defined as the maximum concentration of CD24Fc observed in serum following administration of CD24Fc.
Outcome measures
| Measure |
Saline
n=6 Participants
Single dose of 100 ml normal saline is administrated as intravenous infusion in one hour. Saline: 0.9% sodium chloride
|
CD24Fc 10 mg
n=6 Participants
Single dose of 10 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
|
CD24Fc 30 mg
n=6 Participants
Single dose of 30 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
|
CD24Fc 60 mg
n=6 Participants
Single dose of 60 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
|
CD24Fc 120 mg
n=6 Participants
Single dose of 120 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
|
CD24Fc 240 mg
Single dose of 240 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
|
|---|---|---|---|---|---|---|
|
Maximum Serum Concentration (Cmax) of CD24Fc
|
2495 ng/mL
Standard Deviation 576
|
9735 ng/mL
Standard Deviation 1715
|
30083 ng/mL
Standard Deviation 7179
|
52435 ng/mL
Standard Deviation 9910
|
95865 ng/mL
Standard Deviation 10734
|
—
|
SECONDARY outcome
Timeframe: Up to 42 days after treatmentPopulation: The analysis population included all participants who received at least one dose of study medication and who had evaluable pharmacokinetic AUC 0-42d data for CD24Fc.
AUC was defined as the area of serum concentration versus time curve from time zero to 42 days (AUC 0-42d). Assessment of AUC 0-42d was based on CD24Fc concentration measured at different time points after administration of CD24Fc.
Outcome measures
| Measure |
Saline
n=6 Participants
Single dose of 100 ml normal saline is administrated as intravenous infusion in one hour. Saline: 0.9% sodium chloride
|
CD24Fc 10 mg
n=6 Participants
Single dose of 10 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
|
CD24Fc 30 mg
n=6 Participants
Single dose of 30 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
|
CD24Fc 60 mg
n=6 Participants
Single dose of 60 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
|
CD24Fc 120 mg
n=6 Participants
Single dose of 120 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
|
CD24Fc 240 mg
Single dose of 240 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
|
|---|---|---|---|---|---|---|
|
Area Under the Serum Concentration Curve From 0-42 Days (AUC 0-42d) of CD24Fc
|
423061 ng*hr/mL
Standard Deviation 99615
|
1282430 ng*hr/mL
Standard Deviation 88798
|
3226255 ng*hr/mL
Standard Deviation 702862
|
6541501 ng*hr/mL
Standard Deviation 2190944
|
12704705 ng*hr/mL
Standard Deviation 1918596
|
—
|
SECONDARY outcome
Timeframe: Up to 42 days after treatmentPopulation: The analysis population included all participants who received at least one dose of study medication and who had evaluable t1/2 data for CD24Fc.
t1/2 was defined as the time required to divide the serum concentration by two after reaching maximum concentration (Cmax), following administration of CD24Fc.
Outcome measures
| Measure |
Saline
n=6 Participants
Single dose of 100 ml normal saline is administrated as intravenous infusion in one hour. Saline: 0.9% sodium chloride
|
CD24Fc 10 mg
n=6 Participants
Single dose of 10 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
|
CD24Fc 30 mg
n=6 Participants
Single dose of 30 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
|
CD24Fc 60 mg
n=6 Participants
Single dose of 60 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
|
CD24Fc 120 mg
n=6 Participants
Single dose of 120 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
|
CD24Fc 240 mg
Single dose of 240 mg CD24Fc diluted in 0.9% sodium chloride in final volume of 100 ml is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain.
|
|---|---|---|---|---|---|---|
|
Terminal Elimination Half-Life (t1/2) of CD24Fc
|
280.83 hr
Standard Deviation 22.37
|
327.10 hr
Standard Deviation 41.32
|
279.82 hr
Standard Deviation 65.59
|
286.45 hr
Standard Deviation 23.38
|
285.33 hr
Standard Deviation 24.33
|
—
|
Adverse Events
Saline
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
CD24Fc 10 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
CD24Fc 30 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
CD24Fc 60 mg
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
CD24Fc 120 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
CD24Fc 240 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Saline
n=10 participants at risk
Single dose of 100 ml normal saline is administrated as intravenous infusion in one hour. Saline: 0.9% sodium chloride
|
CD24Fc 10 mg
n=6 participants at risk
Single dose of 10 mg CD24Fc is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain
|
CD24Fc 30 mg
n=6 participants at risk
Single dose of 30 mg CD24Fc is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain
|
CD24Fc 60 mg
n=6 participants at risk
Single dose of 60 mg CD24Fc is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain
|
CD24Fc 120 mg
n=6 participants at risk
Single dose of 120 mg CD24Fc is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain
|
CD24Fc 240 mg
n=6 participants at risk
Single dose of 240 mg CD24Fc is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/10 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
Other adverse events
| Measure |
Saline
n=10 participants at risk
Single dose of 100 ml normal saline is administrated as intravenous infusion in one hour. Saline: 0.9% sodium chloride
|
CD24Fc 10 mg
n=6 participants at risk
Single dose of 10 mg CD24Fc is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain
|
CD24Fc 30 mg
n=6 participants at risk
Single dose of 30 mg CD24Fc is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain
|
CD24Fc 60 mg
n=6 participants at risk
Single dose of 60 mg CD24Fc is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain
|
CD24Fc 120 mg
n=6 participants at risk
Single dose of 120 mg CD24Fc is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain
|
CD24Fc 240 mg
n=6 participants at risk
Single dose of 240 mg CD24Fc is administrated as intravenous infusion in one hour. CD24Fc: Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain
|
|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
10.0%
1/10 • Number of events 1 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
33.3%
2/6 • Number of events 2 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
33.3%
2/6 • Number of events 2 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/10 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Migraine
|
0.00%
0/10 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
|
Nervous system disorders
Presyncope
|
10.0%
1/10 • Number of events 1 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
|
Infections and infestations
Upper Respiratory tract infections
|
10.0%
1/10 • Number of events 1 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
|
Infections and infestations
Pharyngitis
|
10.0%
1/10 • Number of events 1 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
|
Infections and infestations
Viral infection
|
0.00%
0/10 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
10.0%
1/10 • Number of events 1 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/10 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
1/10 • Number of events 1 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/10 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/10 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/10 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
10.0%
1/10 • Number of events 1 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/10 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
16.7%
1/6 • Number of events 1 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
0.00%
0/6 • Up to 42 days after treatment
The analysis population included all participants who received at least one dose of study medication.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place