Phase 1
Completed N=24
Study to Evaluate the Safety, Tolerability,Immunogenicity, and Pharmacokinetics of MEDI-528 in Healthy Adult Volunteers
Source: ClinicalTrials.gov NCT00192296 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcomePrimary: Incidence of Adverse Events — 5; 4; 6; 2 Participants
Summary
Phase I study to evaluate the safety and tolerability of escalating single IV doses of MEDI-528.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Adverse Events |
5; 4; 6; 2 | — |
| PRIMARY Incidence of Abnormal Troponin Levels |
0; 0; 0; 0 | — |
| PRIMARY Incidence of Serious Adverse Events |
0; 0; 0; 0 | — |
| SECONDARY Incidence of Anti-drug Antibodies (ADA) to MEDI-528 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Time to Observed Maximum Serum Concentration (Tmax) |
1.5; 1.1; 1.2; 0.7 | — |
| SECONDARY Observed Maximum Serum Concentration (Cmax) |
7.2; 22.2; 59.7; 231.2 | — |
| SECONDARY Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)] |
2463.7; 7765.6; 26221.5; 101476.7 | — |
| SECONDARY Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)] |
3982.2; 10084.6; 30035.5; 112344.3 | — |
| SECONDARY Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)] |
35.8; 21.5; 10.5; 8.2 | — |
| SECONDARY Total Body Clearance (CL) |
120.5; 160.1; 166.1; 154.6 | — |
| SECONDARY Half-life (T1/2) |
651.1; 559.1; 581.3; 594.9 | — |
| SECONDARY Terminal Phase Elimination Rate (Vz) |
4.7; 5.4; 5.8; 5.5 | — |
Eligibility Criteria
Inclusion Criteria
- Males and females age 18 up to and including 49 years of age at the time of the first dose of study drug
- Weight 10 pack-years
- History of immunodeficiency or receipt or current use of immunosuppressive drugs including systemic corticosteroids
- History of allergic disease or reactions likely to be exacerbated by any component of the Study Drug (described in the Investigator's Brochure)
- History of substance abuse that, in the opinion of the investigator, may compromise the ability of the study subject to complete the study and follow-up period
- Evidence of any systemic disease on physical examination
- Evidence of infection with hepatitis A, B, or C virus or HIV-1
- Receipt of immunoglobulins or blood products within 60 days of entering the study
- Receipt of any investigational drug therapy within 60 days of the first dose of study drug through Study Day 84 (use of licensed agents for indications not listed in the package insert is permitted)
- Any of the following: CBC: Hgb upper limit of normal; other abnormal laboratory values in the screening panel which in the opinion of the principal investigator are judged to be clinically significant.
- Clinically significant abnormality, as determined by the investigator, on 12-lead electrocardiogram at the time of initial screening
- Elective surgery planned during the study period through Study Day 84
- Pregnancy (sexually active females must have a negative serum pregnancy test on the day of the first dose of the study drug, before dosing)
- Nursing mother
- The presence of any acute or chronic organ-specific condition or any concern, which in the opinion of the investigator, may interfere with the conduct or interpretation of the study
Data sourced from ClinicalTrials.gov (NCT00192296). 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. Informational only — not medical advice.