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Safety and Pharmacokinetics of Single and Multiple Ascending Doses of 3K3A-APC in Healthy Adult Volunteers

A Randomized, Double-Blind, Placebo-Controlled Phase 1 Study of the Safety and Pharmacokinetics of Single and Multiple Ascending Doses of 3K3A-APC, a Recombinant Variant of Human Activated Protein C (APC), in Healthy Adult Volunteers

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01660230
Enrollment
64
Registered
2012-08-08
Start date
2012-08-31
Completion date
2012-12-31
Last updated
2018-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

APC, 3K3A, 3K3A-APC, volunteer, healthy

Brief summary

The purpose of this study is to evaluate the safety and pharmacokinetic profile of single and multiple ascending intravenous doses of 3K3A-APC in healthy adult subjects aged 18-55 years.

Detailed description

This is a single-center, sequential-cohort, double-blind, placebo-controlled, single- and multiple-ascending dose study. Eligible adult subjects will be assigned sequentially to 1 of 10 cohorts, at successively higher single doses, followed by successively higher multiple doses. Single IV Doses: 5 subjects per cohort, aged 18-55, will be randomized in a 4:1 manner to receive active drug (6, 30, 90, 180, 360, and TBD µg/kg) or to receive matching placebo (Cohorts 1-6). Multiple IV Doses: 8 subjects per cohort, aged 18-55, will be randomized in a 3:1 manner to receive active drug (90, 180, 360, and TBD µg/kg) or to receive matching placebo every 12 hours for 5 doses (Cohorts 7-10). Single-Dose Cohorts Subjects receiving a single dose will be confined in a Phase 1 unit for 12 hours prior to dosing, during dosing, and for 24 hours after dosing (Study Day 1-2) for observation and PK sampling. Subjects will return on Study Day 4 (\ 72 hours after infusion) and Study Day 15 for additional safety evaluations. A 28-Day follow-up phone call will be made to subjects to collect AEs that occur within 28-days of the dose. Multiple-Dose Cohorts Subjects receiving multiple doses will be confined in a Phase 1 unit for 12 hours prior to dosing through 24 hours following the last dose (Study Day 1-4) for observation and PK sampling. Subjects will return on Study Day 6 (\ 72 hours after last infusion) and Study Day 15 for additional safety evaluations. A 28-Day follow-up phone call will be made to subjects to collect AEs that occur within 28-days of the last dose.

Interventions

BIOLOGICAL3K3A-APC, diluted in 0.9% sodium chloride in water
DRUG0.9% NaCl in water

Sponsors

ZZ Biotech, LLC
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

1. Healthy males or non-pregnant, non-lactating females 2. Both men and women of child-bearing potential (i.e., not surgically sterile or post-menopausal defined as age \> 40 years without menses for ≥ 2 years) must agree to use a barrier method of contraception plus a spermicide throughout the study. 3. Age 18 to 55 years, inclusive 4. Body Mass Index (BMI) of 19 to 30 kg/m2, inclusive (see APPENDIX B) 5. Willing and able to complete all study visits 6. Agreement to abstain from smoking and drinking alcoholic beverages from 48 hours prior to randomization through last Study Day (15) 7. Signed informed consent form (ICF)

Exclusion criteria

1. Any medical problem for which the subject is being evaluated and/or treated 2. Activated partial thromboplastin time (aPTT) greater than upper limit of normal (ULN) 3. Platelet count \< 125,000 cells/mm3 4. International Normalized Ratio (INR) \> 1.3 5. Any other clinically significant abnormalities in laboratory values (chemistries, hematology, coagulation studies, and urinalysis - see APPENDIX C) 6. Clinically significant abnormalities on electrocardiogram (ECG) 7. Positive serum βHCG pregnancy test at screening or on Study Day -1 (for all women, regardless of child-bearing potential) 8. Positive urine drug screen at screening or on Study Day -1 (see APPENDIX C) 9. Positive blood test for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody 10. Known family history of bleeding or blood clotting disorders 11. History of bleeding diathesis 12. History of liver disease with ongoing coagulopathy 13. Use of any prescription or non-prescription medications or supplements within 7 days prior to Study Day -1, excluding hormonal contraceptives 14. Use of anticoagulant medication within 14 days prior to Study Day -1 15. Major surgery within 60 days prior to Study Day -1 16. Receipt of an investigational drug within 30 days prior to Study Day -1 17. Donation of blood or plasma within 30 days prior to Study Day -1 18. Any other condition, that in the opinion of the Site Investigator, may adversely affect the safety of the subject, the subject's ability to complete the study, or the outcome of the study

Design outcomes

Primary

MeasureTime frame
Adverse Events That Meet Dose-limiting Toxicity Criteria Specified in Protocol.Day 4 for single-dose cohorts
Adverse Events That Meet Dose-limiting Toxicity Criteria Specified in the Protocol.Day 6 for multiple-dose cohorts

Secondary

MeasureTime frameDescription
Area Under the Plasma Concentration-time Curve From Time 0 to the Final Time With a Concentration ≥ Limit of Quantitation [AUC(0-t)] for 3K3A-APC by Non-compartmental Analysis0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-doseSingle-dose cohorts
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-inf)] for 3K3A-APC by Non-compartmental Analysis0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-doseSingle-dose cohorts
Elimination Rate Constant (λz) for 3K3A-APC by Non-compartmental Analysis0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-doseSingle-dose cohorts
Half-life (t1/2) of 3K3A-APC by Non-compartmental Analysis0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-doseSingle-dose cohorts
Total Clearance (CL) of 3K3A-APC by Non-compartmental Analysis0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-doseSingle-dose cohorts
Volume of Distribution (Vz) of 3K3A-APC by Non-compartmental Analysis0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-doseSingle-dose cohorts
Maximum Observed Plasma Concentration (Cmax) of 3K3A-APC by Non-compartmental Analysis0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-doseSingle-dose cohorts
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-inf)] for 3K3A-APC by Compartmental Analysis0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-doseSingle-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.
Elimination Rate Constant (λz) for 3K3A-APC by Compartmental Analysis0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-doseSingle-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.
Half-life (t1/2) of 3K3A-APC by Compartmental Analysis0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-doseSingle-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.
Total Clearance (CL) of 3K3A-APC by Compartmental Analysis0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-doseSingle-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.
Volume of Distribution (V) of 3K3A-APC by Compartmental Analysis0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-doseSingle-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.
Maximum Observed Plasma Concentration (Cmax) of 3K3A-APC by Compartmental Analysis0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-doseSingle-dose cohorts
Time at Which Cmax is Observed (Tmax) for 3K3A-APC by Non-compartmental Analysis0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-doseSingle-dose cohorts

Countries

Austria

Participant flow

Participants by arm

ArmCount
6 µg/kg 3K3A-APC, Single-dose
Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes 3K3A-APC, diluted in 0.9% sodium chloride in water
4
30 µg/kg 3K3A-APC, Single-dose
Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes 3K3A-APC, diluted in 0.9% sodium chloride in water
4
90 µg/kg 3K3A-APC, Single-dose
Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes 3K3A-APC, diluted in 0.9% sodium chloride in water
4
180 µg/kg 3K3A-APC, Single-dose
Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes 3K3A-APC, diluted in 0.9% sodium chloride in water
4
360 µg/kg 3K3A-APC, Single-dose
Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes 3K3A-APC, diluted in 0.9% sodium chloride in water
4
720 µg/kg 3K3A-APC, Single-dose
Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes 3K3A-APC, diluted in 0.9% sodium chloride in water
2
540 µg/kg 3K3A-APC, Single-dose
Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes 3K3A-APC, diluted in 0.9% sodium chloride in water
4
90 µg/kg 3K3A-APC, q12h for 5 Doses
Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses 3K3A-APC, diluted in 0.9% sodium chloride in water
6
180 µg/kg 3K3A-APC, q12h for 5 Doses
Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses 3K3A-APC, diluted in 0.9% sodium chloride in water
6
360 µg/kg 3K3A-APC, q12h for 5 Doses
Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses 3K3A-APC, diluted in 0.9% sodium chloride in water
6
540 µg/kg 3K3A-APC, q12h for 5 Doses
Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses 3K3A-APC, diluted in 0.9% sodium chloride in water
6
Matching Placebo, 0.9% NaCl in Water
Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10) 0.9% NaCl in water
14
Total64

Baseline characteristics

Characteristic6 µg/kg 3K3A-APC, Single-doseTotalMatching Placebo, 0.9% NaCl in Water540 µg/kg 3K3A-APC, q12h for 5 Doses360 µg/kg 3K3A-APC, q12h for 5 Doses180 µg/kg 3K3A-APC, q12h for 5 Doses90 µg/kg 3K3A-APC, q12h for 5 Doses540 µg/kg 3K3A-APC, Single-dose720 µg/kg 3K3A-APC, Single-dose360 µg/kg 3K3A-APC, Single-dose180 µg/kg 3K3A-APC, Single-dose90 µg/kg 3K3A-APC, Single-dose30 µg/kg 3K3A-APC, Single-dose
Age, Continuous27.25 years
STANDARD_DEVIATION 10.59
27.03 years
STANDARD_DEVIATION 7.39
29.14 years
STANDARD_DEVIATION 8.08
25.67 years
STANDARD_DEVIATION 5.28
27.50 years
STANDARD_DEVIATION 13
24.50 years
STANDARD_DEVIATION 3.78
27.00 years
STANDARD_DEVIATION 3.58
23.75 years
STANDARD_DEVIATION 2.75
36.00 years
STANDARD_DEVIATION 9.9
28.25 years
STANDARD_DEVIATION 10.11
24.00 years
STANDARD_DEVIATION 2.58
23.75 years
STANDARD_DEVIATION 2.36
28.50 years
STANDARD_DEVIATION 9.26
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants2 Participants1 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
4 Participants61 Participants13 Participants5 Participants6 Participants6 Participants6 Participants4 Participants1 Participants4 Participants4 Participants4 Participants4 Participants
Region of Enrollment
Austria
4 participants64 participants14 participants6 participants6 participants6 participants6 participants4 participants2 participants4 participants4 participants4 participants4 participants
Sex: Female, Male
Female
3 Participants30 Participants8 Participants4 Participants2 Participants1 Participants2 Participants2 Participants2 Participants0 Participants3 Participants1 Participants2 Participants
Sex: Female, Male
Male
1 Participants34 Participants6 Participants2 Participants4 Participants5 Participants4 Participants2 Participants0 Participants4 Participants1 Participants3 Participants2 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
EG007
affected / at risk
EG008
affected / at risk
EG009
affected / at risk
EG010
affected / at risk
EG011
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —— / —— / —— / —— / —— / —— / —— / —— / —
other
Total, other adverse events
0 / 42 / 40 / 41 / 43 / 42 / 24 / 45 / 62 / 66 / 65 / 66 / 14
serious
Total, serious adverse events
0 / 40 / 40 / 40 / 40 / 40 / 20 / 40 / 60 / 60 / 60 / 60 / 14

Outcome results

Primary

Adverse Events That Meet Dose-limiting Toxicity Criteria Specified in Protocol.

Time frame: Day 4 for single-dose cohorts

Population: All 'single-dose' subjects who received at least one dose of study treatment.

ArmMeasureValue (NUMBER)
6 µg/kg 3K3A-APC, Single-doseAdverse Events That Meet Dose-limiting Toxicity Criteria Specified in Protocol.0 participants
30 µg/kg 3K3A-APC, Single-doseAdverse Events That Meet Dose-limiting Toxicity Criteria Specified in Protocol.0 participants
90 µg/kg 3K3A-APC, Single-doseAdverse Events That Meet Dose-limiting Toxicity Criteria Specified in Protocol.0 participants
180 µg/kg 3K3A-APC, Single-doseAdverse Events That Meet Dose-limiting Toxicity Criteria Specified in Protocol.0 participants
360 µg/kg 3K3A-APC, Single-doseAdverse Events That Meet Dose-limiting Toxicity Criteria Specified in Protocol.0 participants
720 µg/kg 3K3A-APC, Single-doseAdverse Events That Meet Dose-limiting Toxicity Criteria Specified in Protocol.0 participants
540 µg/kg 3K3A-APC, Single-doseAdverse Events That Meet Dose-limiting Toxicity Criteria Specified in Protocol.0 participants
Matching Placebo, 0.9% NaCl in WaterAdverse Events That Meet Dose-limiting Toxicity Criteria Specified in Protocol.0 participants
Primary

Adverse Events That Meet Dose-limiting Toxicity Criteria Specified in the Protocol.

Time frame: Day 6 for multiple-dose cohorts

Population: All 'multiple-dose' subjects who received at least one dose of study treatment.

ArmMeasureValue (NUMBER)
6 µg/kg 3K3A-APC, Single-doseAdverse Events That Meet Dose-limiting Toxicity Criteria Specified in the Protocol.0 participants
30 µg/kg 3K3A-APC, Single-doseAdverse Events That Meet Dose-limiting Toxicity Criteria Specified in the Protocol.0 participants
90 µg/kg 3K3A-APC, Single-doseAdverse Events That Meet Dose-limiting Toxicity Criteria Specified in the Protocol.0 participants
180 µg/kg 3K3A-APC, Single-doseAdverse Events That Meet Dose-limiting Toxicity Criteria Specified in the Protocol.0 participants
360 µg/kg 3K3A-APC, Single-doseAdverse Events That Meet Dose-limiting Toxicity Criteria Specified in the Protocol.0 participants
Secondary

Area Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-inf)] for 3K3A-APC by Compartmental Analysis

Single-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.

Time frame: 0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose

Population: All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.

ArmMeasureValue (MEAN)Dispersion
30 µg/kg 3K3A-APC, Single-doseArea Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-inf)] for 3K3A-APC by Compartmental Analysis123 h * ng/mLStandard Deviation 32
90 µg/kg 3K3A-APC, Single-doseArea Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-inf)] for 3K3A-APC by Compartmental Analysis381 h * ng/mLStandard Deviation 29.6
180 µg/kg 3K3A-APC, Single-doseArea Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-inf)] for 3K3A-APC by Compartmental Analysis623 h * ng/mLStandard Deviation 131
360 µg/kg 3K3A-APC, Single-doseArea Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-inf)] for 3K3A-APC by Compartmental Analysis1615 h * ng/mLStandard Deviation 142
720 µg/kg 3K3A-APC, Single-doseArea Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-inf)] for 3K3A-APC by Compartmental Analysis3195 h * ng/mLStandard Deviation 263
540 µg/kg 3K3A-APC, Single-doseArea Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-inf)] for 3K3A-APC by Compartmental Analysis2309 h * ng/mLStandard Deviation 191
Secondary

Area Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-inf)] for 3K3A-APC by Compartmental Analysis

Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.

Time frame: 0, 20 minutes and 1 hour post for doses 1 and 5

Population: All 'multiple-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.

ArmMeasureValue (MEAN)Dispersion
6 µg/kg 3K3A-APC, Single-doseArea Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-inf)] for 3K3A-APC by Compartmental Analysis370 h * ng/mLStandard Deviation 145
30 µg/kg 3K3A-APC, Single-doseArea Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-inf)] for 3K3A-APC by Compartmental Analysis794 h * ng/mLStandard Deviation 148
90 µg/kg 3K3A-APC, Single-doseArea Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-inf)] for 3K3A-APC by Compartmental Analysis1634 h * ng/mLStandard Deviation 365
180 µg/kg 3K3A-APC, Single-doseArea Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-inf)] for 3K3A-APC by Compartmental Analysis2750 h * ng/mLStandard Deviation 512
Secondary

Area Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-inf)] for 3K3A-APC by Non-compartmental Analysis

Single-dose cohorts

Time frame: 0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose

Population: All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.

ArmMeasureValue (MEAN)Dispersion
30 µg/kg 3K3A-APC, Single-doseArea Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-inf)] for 3K3A-APC by Non-compartmental Analysis114 h * ng/mLStandard Deviation 31.9
90 µg/kg 3K3A-APC, Single-doseArea Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-inf)] for 3K3A-APC by Non-compartmental Analysis374 h * ng/mLStandard Deviation 31.8
180 µg/kg 3K3A-APC, Single-doseArea Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-inf)] for 3K3A-APC by Non-compartmental Analysis664 h * ng/mLStandard Deviation 112
360 µg/kg 3K3A-APC, Single-doseArea Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-inf)] for 3K3A-APC by Non-compartmental Analysis1555 h * ng/mLStandard Deviation 147
720 µg/kg 3K3A-APC, Single-doseArea Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-inf)] for 3K3A-APC by Non-compartmental Analysis3087 h * ng/mLStandard Deviation 178
540 µg/kg 3K3A-APC, Single-doseArea Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-inf)] for 3K3A-APC by Non-compartmental Analysis2226 h * ng/mLStandard Deviation 188
Secondary

Area Under the Plasma Concentration-time Curve From Time 0 to the Final Time With a Concentration ≥ Limit of Quantitation [AUC(0-t)] for 3K3A-APC by Non-compartmental Analysis

Single-dose cohorts

Time frame: 0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose

Population: All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.

ArmMeasureValue (MEAN)Dispersion
30 µg/kg 3K3A-APC, Single-doseArea Under the Plasma Concentration-time Curve From Time 0 to the Final Time With a Concentration ≥ Limit of Quantitation [AUC(0-t)] for 3K3A-APC by Non-compartmental Analysis85.8 h * ng/mLStandard Deviation 33.9
90 µg/kg 3K3A-APC, Single-doseArea Under the Plasma Concentration-time Curve From Time 0 to the Final Time With a Concentration ≥ Limit of Quantitation [AUC(0-t)] for 3K3A-APC by Non-compartmental Analysis327 h * ng/mLStandard Deviation 31.2
180 µg/kg 3K3A-APC, Single-doseArea Under the Plasma Concentration-time Curve From Time 0 to the Final Time With a Concentration ≥ Limit of Quantitation [AUC(0-t)] for 3K3A-APC by Non-compartmental Analysis615 h * ng/mLStandard Deviation 101
360 µg/kg 3K3A-APC, Single-doseArea Under the Plasma Concentration-time Curve From Time 0 to the Final Time With a Concentration ≥ Limit of Quantitation [AUC(0-t)] for 3K3A-APC by Non-compartmental Analysis1492 h * ng/mLStandard Deviation 140
720 µg/kg 3K3A-APC, Single-doseArea Under the Plasma Concentration-time Curve From Time 0 to the Final Time With a Concentration ≥ Limit of Quantitation [AUC(0-t)] for 3K3A-APC by Non-compartmental Analysis3025 h * ng/mLStandard Deviation 174
540 µg/kg 3K3A-APC, Single-doseArea Under the Plasma Concentration-time Curve From Time 0 to the Final Time With a Concentration ≥ Limit of Quantitation [AUC(0-t)] for 3K3A-APC by Non-compartmental Analysis2156 h * ng/mLStandard Deviation 176
Secondary

Elimination Rate Constant (λz) for 3K3A-APC by Compartmental Analysis

Single-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.

Time frame: 0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose

Population: All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.

ArmMeasureValue (MEAN)Dispersion
30 µg/kg 3K3A-APC, Single-doseElimination Rate Constant (λz) for 3K3A-APC by Compartmental Analysis2.85 L/hStandard Deviation 0.3
90 µg/kg 3K3A-APC, Single-doseElimination Rate Constant (λz) for 3K3A-APC by Compartmental Analysis2.69 L/hStandard Deviation 0.49
180 µg/kg 3K3A-APC, Single-doseElimination Rate Constant (λz) for 3K3A-APC by Compartmental Analysis3.08 L/hStandard Deviation 0.65
360 µg/kg 3K3A-APC, Single-doseElimination Rate Constant (λz) for 3K3A-APC by Compartmental Analysis2.96 L/hStandard Deviation 0.33
720 µg/kg 3K3A-APC, Single-doseElimination Rate Constant (λz) for 3K3A-APC by Compartmental Analysis2.40 L/hStandard Deviation 0.44
540 µg/kg 3K3A-APC, Single-doseElimination Rate Constant (λz) for 3K3A-APC by Compartmental Analysis2.68 L/hStandard Deviation 0.49
Secondary

Elimination Rate Constant (λz) for 3K3A-APC by Compartmental Analysis

Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.

Time frame: 0, 20 minutes and 1 hour post for doses 1 and 5

Population: All 'multiple-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.

ArmMeasureValue (MEAN)Dispersion
6 µg/kg 3K3A-APC, Single-doseElimination Rate Constant (λz) for 3K3A-APC by Compartmental Analysis3.87 L/hStandard Deviation 1.58
30 µg/kg 3K3A-APC, Single-doseElimination Rate Constant (λz) for 3K3A-APC by Compartmental Analysis2.50 L/hStandard Deviation 0.46
90 µg/kg 3K3A-APC, Single-doseElimination Rate Constant (λz) for 3K3A-APC by Compartmental Analysis2.47 L/hStandard Deviation 0.2
180 µg/kg 3K3A-APC, Single-doseElimination Rate Constant (λz) for 3K3A-APC by Compartmental Analysis2.83 L/hStandard Deviation 0.25
Secondary

Elimination Rate Constant (λz) for 3K3A-APC by Non-compartmental Analysis

Single-dose cohorts

Time frame: 0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose

Population: All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.

ArmMeasureValue (MEAN)Dispersion
30 µg/kg 3K3A-APC, Single-doseElimination Rate Constant (λz) for 3K3A-APC by Non-compartmental Analysis3.45 L/hStandard Deviation 0.84
90 µg/kg 3K3A-APC, Single-doseElimination Rate Constant (λz) for 3K3A-APC by Non-compartmental Analysis2.69 L/hStandard Deviation 0.5
180 µg/kg 3K3A-APC, Single-doseElimination Rate Constant (λz) for 3K3A-APC by Non-compartmental Analysis2.73 L/hStandard Deviation 0.47
360 µg/kg 3K3A-APC, Single-doseElimination Rate Constant (λz) for 3K3A-APC by Non-compartmental Analysis2.50 L/hStandard Deviation 0.47
720 µg/kg 3K3A-APC, Single-doseElimination Rate Constant (λz) for 3K3A-APC by Non-compartmental Analysis1.81 L/hStandard Deviation 0.32
540 µg/kg 3K3A-APC, Single-doseElimination Rate Constant (λz) for 3K3A-APC by Non-compartmental Analysis2.03 L/hStandard Deviation 0.32
Secondary

Half-life (t1/2) of 3K3A-APC by Compartmental Analysis

Single-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.

Time frame: 0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose

Population: All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.

ArmMeasureValue (MEAN)Dispersion
30 µg/kg 3K3A-APC, Single-doseHalf-life (t1/2) of 3K3A-APC by Compartmental Analysis0.246 hStandard Deviation 0.027
90 µg/kg 3K3A-APC, Single-doseHalf-life (t1/2) of 3K3A-APC by Compartmental Analysis0.263 hStandard Deviation 0.043
180 µg/kg 3K3A-APC, Single-doseHalf-life (t1/2) of 3K3A-APC by Compartmental Analysis0.232 hStandard Deviation 0.046
360 µg/kg 3K3A-APC, Single-doseHalf-life (t1/2) of 3K3A-APC by Compartmental Analysis0.237 hStandard Deviation 0.029
720 µg/kg 3K3A-APC, Single-doseHalf-life (t1/2) of 3K3A-APC by Compartmental Analysis0.294 hStandard Deviation 0.054
540 µg/kg 3K3A-APC, Single-doseHalf-life (t1/2) of 3K3A-APC by Compartmental Analysis0.264 hStandard Deviation 0.041
Secondary

Half-life (t1/2) of 3K3A-APC by Compartmental Analysis

Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.

Time frame: 0, 20 minutes and 1 hour post for doses 1 and 5

Population: All 'multiple-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.

ArmMeasureValue (MEAN)Dispersion
6 µg/kg 3K3A-APC, Single-doseHalf-life (t1/2) of 3K3A-APC by Compartmental Analysis0.211 hStandard Deviation 0.097
30 µg/kg 3K3A-APC, Single-doseHalf-life (t1/2) of 3K3A-APC by Compartmental Analysis0.284 hStandard Deviation 0.044
90 µg/kg 3K3A-APC, Single-doseHalf-life (t1/2) of 3K3A-APC by Compartmental Analysis0.282 hStandard Deviation 0.022
180 µg/kg 3K3A-APC, Single-doseHalf-life (t1/2) of 3K3A-APC by Compartmental Analysis0.247 hStandard Deviation 0.022
Secondary

Half-life (t1/2) of 3K3A-APC by Non-compartmental Analysis

Single-dose cohorts

Time frame: 0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose

Population: All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.

ArmMeasureValue (MEAN)Dispersion
30 µg/kg 3K3A-APC, Single-doseHalf-life (t1/2) of 3K3A-APC by Non-compartmental Analysis0.208 hStandard Deviation 0.041
90 µg/kg 3K3A-APC, Single-doseHalf-life (t1/2) of 3K3A-APC by Non-compartmental Analysis0.263 hStandard Deviation 0.043
180 µg/kg 3K3A-APC, Single-doseHalf-life (t1/2) of 3K3A-APC by Non-compartmental Analysis0.259 hStandard Deviation 0.045
360 µg/kg 3K3A-APC, Single-doseHalf-life (t1/2) of 3K3A-APC by Non-compartmental Analysis0.285 hStandard Deviation 0.054
720 µg/kg 3K3A-APC, Single-doseHalf-life (t1/2) of 3K3A-APC by Non-compartmental Analysis0.388 hStandard Deviation 0.069
540 µg/kg 3K3A-APC, Single-doseHalf-life (t1/2) of 3K3A-APC by Non-compartmental Analysis0.347 hStandard Deviation 0.049
Secondary

Maximum Observed Plasma Concentration (Cmax) of 3K3A-APC by Compartmental Analysis

Single-dose cohorts

Time frame: 0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose

Population: All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.

ArmMeasureValue (MEAN)Dispersion
30 µg/kg 3K3A-APC, Single-doseMaximum Observed Plasma Concentration (Cmax) of 3K3A-APC by Compartmental Analysis249 ng/mLStandard Deviation 59.2
90 µg/kg 3K3A-APC, Single-doseMaximum Observed Plasma Concentration (Cmax) of 3K3A-APC by Compartmental Analysis741 ng/mLStandard Deviation 50.2
180 µg/kg 3K3A-APC, Single-doseMaximum Observed Plasma Concentration (Cmax) of 3K3A-APC by Compartmental Analysis1300 ng/mLStandard Deviation 111
360 µg/kg 3K3A-APC, Single-doseMaximum Observed Plasma Concentration (Cmax) of 3K3A-APC by Compartmental Analysis3374 ng/mLStandard Deviation 490
720 µg/kg 3K3A-APC, Single-doseMaximum Observed Plasma Concentration (Cmax) of 3K3A-APC by Compartmental Analysis5715 ng/mLStandard Deviation 306
540 µg/kg 3K3A-APC, Single-doseMaximum Observed Plasma Concentration (Cmax) of 3K3A-APC by Compartmental Analysis4489 ng/mLStandard Deviation 654
Secondary

Maximum Observed Plasma Concentration (Cmax) of 3K3A-APC by Compartmental Analysis

Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.

Time frame: 0, 20 minutes and 1 hour post for doses 1 and 5

Population: All 'multiple-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.

ArmMeasureValue (MEAN)Dispersion
6 µg/kg 3K3A-APC, Single-doseMaximum Observed Plasma Concentration (Cmax) of 3K3A-APC by Compartmental Analysis810 ng/mLStandard Deviation 118
30 µg/kg 3K3A-APC, Single-doseMaximum Observed Plasma Concentration (Cmax) of 3K3A-APC by Compartmental Analysis1447 ng/mLStandard Deviation 135
90 µg/kg 3K3A-APC, Single-doseMaximum Observed Plasma Concentration (Cmax) of 3K3A-APC by Compartmental Analysis2990 ng/mLStandard Deviation 608
180 µg/kg 3K3A-APC, Single-doseMaximum Observed Plasma Concentration (Cmax) of 3K3A-APC by Compartmental Analysis5577 ng/mLStandard Deviation 1134
Secondary

Maximum Observed Plasma Concentration (Cmax) of 3K3A-APC by Non-compartmental Analysis

Single-dose cohorts

Time frame: 0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose

Population: All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.

ArmMeasureValue (MEAN)Dispersion
30 µg/kg 3K3A-APC, Single-doseMaximum Observed Plasma Concentration (Cmax) of 3K3A-APC by Non-compartmental Analysis248 ng/mLStandard Deviation 64.1
90 µg/kg 3K3A-APC, Single-doseMaximum Observed Plasma Concentration (Cmax) of 3K3A-APC by Non-compartmental Analysis745 ng/mLStandard Deviation 33.2
180 µg/kg 3K3A-APC, Single-doseMaximum Observed Plasma Concentration (Cmax) of 3K3A-APC by Non-compartmental Analysis1423 ng/mLStandard Deviation 131
360 µg/kg 3K3A-APC, Single-doseMaximum Observed Plasma Concentration (Cmax) of 3K3A-APC by Non-compartmental Analysis3562 ng/mLStandard Deviation 512
720 µg/kg 3K3A-APC, Single-doseMaximum Observed Plasma Concentration (Cmax) of 3K3A-APC by Non-compartmental Analysis6115 ng/mLStandard Deviation 522
540 µg/kg 3K3A-APC, Single-doseMaximum Observed Plasma Concentration (Cmax) of 3K3A-APC by Non-compartmental Analysis4428 ng/mLStandard Deviation 462
Secondary

Time at Which Cmax is Observed (Tmax) for 3K3A-APC by Non-compartmental Analysis

Single-dose cohorts

Time frame: 0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose

Population: All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.

ArmMeasureValue (MEDIAN)
30 µg/kg 3K3A-APC, Single-doseTime at Which Cmax is Observed (Tmax) for 3K3A-APC by Non-compartmental Analysis0.250 hour (from start of infusion)
90 µg/kg 3K3A-APC, Single-doseTime at Which Cmax is Observed (Tmax) for 3K3A-APC by Non-compartmental Analysis0.250 hour (from start of infusion)
180 µg/kg 3K3A-APC, Single-doseTime at Which Cmax is Observed (Tmax) for 3K3A-APC by Non-compartmental Analysis0.250 hour (from start of infusion)
360 µg/kg 3K3A-APC, Single-doseTime at Which Cmax is Observed (Tmax) for 3K3A-APC by Non-compartmental Analysis0.333 hour (from start of infusion)
720 µg/kg 3K3A-APC, Single-doseTime at Which Cmax is Observed (Tmax) for 3K3A-APC by Non-compartmental Analysis0.250 hour (from start of infusion)
540 µg/kg 3K3A-APC, Single-doseTime at Which Cmax is Observed (Tmax) for 3K3A-APC by Non-compartmental Analysis0.250 hour (from start of infusion)
Secondary

Total Clearance (CL) of 3K3A-APC by Compartmental Analysis

Single-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.

Time frame: 0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose

Population: All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.

ArmMeasureValue (MEAN)Dispersion
30 µg/kg 3K3A-APC, Single-doseTotal Clearance (CL) of 3K3A-APC by Compartmental Analysis17,017 mL/h—
90 µg/kg 3K3A-APC, Single-doseTotal Clearance (CL) of 3K3A-APC by Compartmental Analysis18,016 mL/h—
180 µg/kg 3K3A-APC, Single-doseTotal Clearance (CL) of 3K3A-APC by Compartmental Analysis17,981 mL/h—
360 µg/kg 3K3A-APC, Single-doseTotal Clearance (CL) of 3K3A-APC by Compartmental Analysis17,372 mL/h—
720 µg/kg 3K3A-APC, Single-doseTotal Clearance (CL) of 3K3A-APC by Compartmental Analysis11,693 mL/hStandard Deviation 807
540 µg/kg 3K3A-APC, Single-doseTotal Clearance (CL) of 3K3A-APC by Compartmental Analysis16,665 mL/h—
Secondary

Total Clearance (CL) of 3K3A-APC by Compartmental Analysis

Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.

Time frame: 0, 20 minutes and 1 hour post for doses 1 and 5

Population: All 'multiple-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.

ArmMeasureValue (MEAN)
6 µg/kg 3K3A-APC, Single-doseTotal Clearance (CL) of 3K3A-APC by Compartmental Analysis18,701 mL/h
30 µg/kg 3K3A-APC, Single-doseTotal Clearance (CL) of 3K3A-APC by Compartmental Analysis17,177 mL/h
90 µg/kg 3K3A-APC, Single-doseTotal Clearance (CL) of 3K3A-APC by Compartmental Analysis14,231 mL/h
180 µg/kg 3K3A-APC, Single-doseTotal Clearance (CL) of 3K3A-APC by Compartmental Analysis13,647 mL/h
Secondary

Total Clearance (CL) of 3K3A-APC by Non-compartmental Analysis

Single-dose cohorts

Time frame: 0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose

Population: All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.

ArmMeasureValue (MEAN)Dispersion
30 µg/kg 3K3A-APC, Single-doseTotal Clearance (CL) of 3K3A-APC by Non-compartmental Analysis18,556 mL/h—
90 µg/kg 3K3A-APC, Single-doseTotal Clearance (CL) of 3K3A-APC by Non-compartmental Analysis18,328 mL/h—
180 µg/kg 3K3A-APC, Single-doseTotal Clearance (CL) of 3K3A-APC by Non-compartmental Analysis16,883 mL/hStandard Deviation 573
360 µg/kg 3K3A-APC, Single-doseTotal Clearance (CL) of 3K3A-APC by Non-compartmental Analysis18,036 mL/h—
720 µg/kg 3K3A-APC, Single-doseTotal Clearance (CL) of 3K3A-APC by Non-compartmental Analysis12,081 mL/hStandard Deviation 535
540 µg/kg 3K3A-APC, Single-doseTotal Clearance (CL) of 3K3A-APC by Non-compartmental Analysis17,285 mL/h—
Secondary

Volume of Distribution (V) of 3K3A-APC by Compartmental Analysis

Multiple-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.

Time frame: 0, 20 minutes and 1 hour post for doses 1 and 5

Population: All 'multiple-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.

ArmMeasureValue (MEAN)Dispersion
6 µg/kg 3K3A-APC, Single-doseVolume of Distribution (V) of 3K3A-APC by Compartmental Analysis5151 mLStandard Deviation 982
30 µg/kg 3K3A-APC, Single-doseVolume of Distribution (V) of 3K3A-APC by Compartmental Analysis6971 mLStandard Deviation 1169
90 µg/kg 3K3A-APC, Single-doseVolume of Distribution (V) of 3K3A-APC by Compartmental Analysis5732 mLStandard Deviation 645
180 µg/kg 3K3A-APC, Single-doseVolume of Distribution (V) of 3K3A-APC by Compartmental Analysis4873 mLStandard Deviation 828
Secondary

Volume of Distribution (V) of 3K3A-APC by Compartmental Analysis

Single-dose cohorts; primary parameters (CL, V) were used to fit the model. Secondary parameters (Cmax, AUC(inf), λz, t1/2) were estimated from the primary parameters.

Time frame: 0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose

Population: All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.

ArmMeasureValue (MEAN)Dispersion
30 µg/kg 3K3A-APC, Single-doseVolume of Distribution (V) of 3K3A-APC by Compartmental Analysis5967 mLStandard Deviation 1236
90 µg/kg 3K3A-APC, Single-doseVolume of Distribution (V) of 3K3A-APC by Compartmental Analysis6831 mLStandard Deviation 1231
180 µg/kg 3K3A-APC, Single-doseVolume of Distribution (V) of 3K3A-APC by Compartmental Analysis5931 mLStandard Deviation 726
360 µg/kg 3K3A-APC, Single-doseVolume of Distribution (V) of 3K3A-APC by Compartmental Analysis5970 mLStandard Deviation 1194
720 µg/kg 3K3A-APC, Single-doseVolume of Distribution (V) of 3K3A-APC by Compartmental Analysis4922 mLStandard Deviation 574
540 µg/kg 3K3A-APC, Single-doseVolume of Distribution (V) of 3K3A-APC by Compartmental Analysis6359 mLStandard Deviation 1277
Secondary

Volume of Distribution (Vz) of 3K3A-APC by Non-compartmental Analysis

Single-dose cohorts

Time frame: 0, 5, 10, 15, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 4, 6 and 8 hours post-dose

Population: All 'single-dose' subjects who received at least one dose of study treatment and who have sufficient data for PK analysis and who have not been excluded from analysis for protocol deviations or other study-related events that could impact the calculation or interpretation of the pharmacokinetic parameters.

ArmMeasureValue (MEAN)Dispersion
30 µg/kg 3K3A-APC, Single-doseVolume of Distribution (Vz) of 3K3A-APC by Non-compartmental Analysis5,494 mL—
90 µg/kg 3K3A-APC, Single-doseVolume of Distribution (Vz) of 3K3A-APC by Non-compartmental Analysis6,934 mL—
180 µg/kg 3K3A-APC, Single-doseVolume of Distribution (Vz) of 3K3A-APC by Non-compartmental Analysis6,727 mLStandard Deviation 944
360 µg/kg 3K3A-APC, Single-doseVolume of Distribution (Vz) of 3K3A-APC by Non-compartmental Analysis7,412 mL—
720 µg/kg 3K3A-APC, Single-doseVolume of Distribution (Vz) of 3K3A-APC by Non-compartmental Analysis6,744 mLStandard Deviation 911
540 µg/kg 3K3A-APC, Single-doseVolume of Distribution (Vz) of 3K3A-APC by Non-compartmental Analysis8,674 mL—

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026