Phase 1
Completed N=20
A Phase 1, Open-label Study to Investigate the Pharmacokinetics of Tralokinumab (CAT-354) in Adolescents With Asthma
Source: ClinicalTrials.gov NCT01592396 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcomePrimary: Time to Reach Maximum Observed Serum Concentration (Tmax) — 5.2; 6.1 days
Summary
The pharmacokinetic (PK) profile of tralokinumab (CAT-354) will be studied in adolescent subjects with asthma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Reach Maximum Observed Serum Concentration (Tmax) |
5.2; 6.1 | — |
| PRIMARY Maximum Observed Serum Concentration (Cmax) |
57.0; 50.6 | — |
| PRIMARY Area Under the Concentration-time Curve From Zero to Infinity (AUC [0-infinity]) |
1916.0; 1721.1 | — |
| PRIMARY Area Under the Concentration-Time Curve From Zero to Last Measurable Concentration (AUC [0-t]) |
1561.4; 1384.6 | — |
| PRIMARY Terminal Phase Elimination Half Life (t1/2) |
21.4; 22.1 | — |
| SECONDARY Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) |
6; 0 | — |
| SECONDARY Number of Participants Exhibiting Anti-Drug Antibodies for Tralokinumab at Any Visit |
— | — |
Eligibility Criteria
Inclusion Criteria
- Age 12-17 years (inclusive)
- Weight greater than (>) 30 kilogram (kg)
- Asthma for a minimum of 6 months prior to Screening
- Effective birth control for both male and female participants in line with protocol details.
- 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 less than (<) 3 months prior to screening
- Known immune deficiency excluding asymptomatic selective immunoglobulin A
- History of cancer - Hepatitis B, C or human immunodeficiency virus (HIV) positive
- Any disease which may cause complications whilst taking the study drug.
Data sourced from ClinicalTrials.gov (NCT01592396). 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.