Phase 1
N=64
Safety and Pharmacokinetics of Single and Multiple Ascending Doses of 3K3A-APC in Healthy Adult Volunteers
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT01660230 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcome: Primary: Adverse Events That Meet Dose-limiting Toxicity Criteria Specified in Protocol. — 0; 0; 0; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- 3K3A-APC, diluted in 0.9% sodium chloride in water (Biological); 0.9% NaCl in water (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- ZZ Biotech, LLC
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events That Meet Dose-limiting Toxicity Criteria Specified in Protocol. |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Adverse Events That Meet Dose-limiting Toxicity Criteria Specified in the Protocol. |
0; 0; 0; 0; 0 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of 3K3A-APC by Non-compartmental Analysis |
248; 745; 1423; 3562; 6115; 4428 | — |
| SECONDARY Time at Which Cmax is Observed (Tmax) for 3K3A-APC by Non-compartmental Analysis |
0.250; 0.250; 0.250; 0.333; 0.250; 0.250 | — |
| 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 |
85.8; 327; 615; 1492; 3025; 2156 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-inf)] for 3K3A-APC by Non-compartmental Analysis |
114; 374; 664; 1555; 3087; 2226 | — |
| SECONDARY Elimination Rate Constant (λz) for 3K3A-APC by Non-compartmental Analysis |
3.45; 2.69; 2.73; 2.50; 1.81; 2.03 | — |
| SECONDARY Half-life (t1/2) of 3K3A-APC by Non-compartmental Analysis |
0.208; 0.263; 0.259; 0.285; 0.388; 0.347 | — |
| SECONDARY Total Clearance (CL) of 3K3A-APC by Non-compartmental Analysis |
18,556; 18,328; 16,883; 18,036; 12,081; 17,285 | — |
| SECONDARY Volume of Distribution (Vz) of 3K3A-APC by Non-compartmental Analysis |
5,494; 6,934; 6,727; 7,412; 6,744; 8,674 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of 3K3A-APC by Compartmental Analysis |
810; 1447; 2990; 5577 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-inf)] for 3K3A-APC by Compartmental Analysis |
370; 794; 1634; 2750 | — |
| SECONDARY Elimination Rate Constant (λz) for 3K3A-APC by Compartmental Analysis |
3.87; 2.50; 2.47; 2.83 | — |
| SECONDARY Half-life (t1/2) of 3K3A-APC by Compartmental Analysis |
0.211; 0.284; 0.282; 0.247 | — |
| SECONDARY Total Clearance (CL) of 3K3A-APC by Compartmental Analysis |
18,701; 17,177; 14,231; 13,647 | — |
| SECONDARY Volume of Distribution (V) of 3K3A-APC by Compartmental Analysis |
5151; 6971; 5732; 4873 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of 3K3A-APC by Compartmental Analysis |
810; 1447; 2990; 5577 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From Time 0 to Infinity [AUC(0-inf)] for 3K3A-APC by Compartmental Analysis |
370; 794; 1634; 2750 | — |
| SECONDARY Elimination Rate Constant (λz) for 3K3A-APC by Compartmental Analysis |
3.87; 2.50; 2.47; 2.83 | — |
| SECONDARY Half-life (t1/2) of 3K3A-APC by Compartmental Analysis |
0.211; 0.284; 0.282; 0.247 | — |
| SECONDARY Total Clearance (CL) of 3K3A-APC by Compartmental Analysis |
18,701; 17,177; 14,231; 13,647 | — |
| SECONDARY Volume of Distribution (V) of 3K3A-APC by Compartmental Analysis |
5151; 6971; 5732; 4873 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Healthy males or non-pregnant, non-lactating females
- 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.
- Age 18 to 55 years, inclusive
- Body Mass Index (BMI) of 19 to 30 kg/m2, inclusive (see APPENDIX B)
- Willing and able to complete all study visits
- Agreement to abstain from smoking and drinking alcoholic beverages from 48 hours prior to randomization through last Study Day (15)
- Signed informed consent form (ICF)
Exclusion Criteria
- Any medical problem for which the subject is being evaluated and/or treated
- Activated partial thromboplastin time (aPTT) greater than upper limit of normal (ULN)
- Platelet count 1.3
- Any other clinically significant abnormalities in laboratory values (chemistries, hematology, coagulation studies, and urinalysis - see APPENDIX C)
- Clinically significant abnormalities on electrocardiogram (ECG)
- Positive serum βHCG pregnancy test at screening or on Study Day -1 (for all women, regardless of child-bearing potential)
- Positive urine drug screen at screening or on Study Day -1 (see APPENDIX C)
- Positive blood test for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody
- Known family history of bleeding or blood clotting disorders
- History of bleeding diathesis
- History of liver disease with ongoing coagulopathy
- Use of any prescription or non-prescription medications or supplements within 7 days prior to Study Day -1, excluding hormonal contraceptives
- Use of anticoagulant medication within 14 days prior to Study Day -1
- Major surgery within 60 days prior to Study Day -1
- Receipt of an investigational drug within 30 days prior to Study Day -1
- Donation of blood or plasma within 30 days prior to Study Day -1
- 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
Data sourced from ClinicalTrials.gov (NCT01660230). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.