Asthma MedDRA version: 14.1 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Sponsors
MedImmune Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Age 12-17 years (inclusive) •Weight > 30kg •Asthma for a minimum of 6 months •Effective birth control for both male and female participants in line with protocol details. Are the trial subjects under 18? yes Number of subjects for this age range: 20 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Previously taken tralokinumab (the study drug) •Employee of the clinical study site or any other individuals directly involved with the conduct of the study, or immediate family members of such individuals. •Pregnant or breastfeeding women •Current smoker or cessation < 3 months •Known immune deficiency •History of cancer •Hepatitis B, C or HIV •Any disease which may cause complications whilst taking the study drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Individual tralokinumab serum concentrations will be tabulated along with descriptive statistics. A battery of standard PK parameters will be collected and will include areas under the time-concentration curves from zero to infinity and to last observation (AUC(0-infinity); AUC(0-t)); dose-normalized AUC(0-infinity) (AUC(0-infinity)/D); Cmax; dose-normalized Cmax (Cmax/D); time to Cmax (Tmax); terminal-phase elimination half-life (t1/2); apparent clearance (CL/F); steady-state volume of distribution (Vss/F).;Timepoint(s) of evaluation of this end point: There will be 10 PK assessments from administration of investigational product up to, and including, Day 57.;Main Objective: To evaluate the pharmacokinetics of tralokinumab in adolescent subjects with asthma.;Secondary Objective: To evaluate the safety, tolerability and immunogenicity (IM) of tralokinumab. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To evaluate the safety, tolerability and immunogenicity of tralokinumab.;Timepoint(s) of evaluation of this end point: There will be ongoing assessments of the safety, tolerability and immunogenicity of tralokinumab from administration of investigational product up to, and including, Day 57. | — |
Countries
Poland
Contacts
Public ContactWojciech Wojtyczka
Associated Medical Clinical Science Services
Outcome results
None listed