Phase 1
Completed N=60
A Study of Tralokinumab When Delivered Subcutaneously at Different Flow Rates to Healthy Volunteers
Asthma · Healthy Subjects or Volunteers
Source: ClinicalTrials.gov NCT02085473 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Nov 2018
Primary outcomePrimary: Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity]) — 1426.47; 1243.28; 1251.63; 897.02 day*mcg/mL
Summary
The primary objective of this study is to evaluate the pharmacokinetics (PK) and tolerability of tralokinumab when delivered subcutaneously at different flow rates to healthy volunteers.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity]) |
1426.47; 1243.28; 1251.63; 897.02 | — |
| PRIMARY Maximum Observed Serum Concentration (Cmax) |
41.65; 34.07; 36.12; 27.04 | — |
| PRIMARY Time to Maximum Concentration (Tmax) |
8; 6; 8; 6 | — |
| PRIMARY Area Under the Concentration-Time Curve From Zero to Last Measurable Concentration (AUC [0-t]) |
1154.91; 998.08; 1013.98; 685.66 | — |
| PRIMARY Terminal Elimination Half-life (t1/2) |
21.62; 22.00; 21.91; 20.61 | — |
| PRIMARY Apparent Systemic Clearance (CL/F) After Subcutaneous Dose |
210.31; 241.30; 239.69; 334.44 | — |
| PRIMARY Apparent Terminal-Phase Volume of Distribution (Vz/F) |
6559.99; 7657.96; 7577.56; 9944.14 | — |
| SECONDARY Local Injection-Site Pain and Injection-Site Pruritus |
6.7; 4.8; 21.9; 41.0; 17.7; 5.1 | — |
| SECONDARY Number of Participants Reporting Local Injection-Site Reactions |
7; 5; 12; 11; 2; 1 | — |
| SECONDARY Number of Participants Reporting Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) |
5; 5; 4; 4; 0; 0 | — |
| SECONDARY Number of Participants Reporting Treatment-emergent Adverse Events Related to Physical Examination |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants Reporting Treatment-emergent Adverse Events Related to Vital Signs |
0; 0; 0; 0 | — |
| SECONDARY Number of Participants Reporting Treatment-emergent Adverse Events in Laboratory Parameters |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants Exhibiting Anti-Drug Antibodies for Tralokinumab at Any Visit |
0; 0; 0; 0 | — |
Eligibility Criteria
Key Inclusion Criteria
- Healthy males and females ages 19-65 years
- Body mass index of 19.0-30.0 kilogram per meter square (kg/m^2)
- No clinically significant abnormality
- Vital signs, electrocardiogram (ECG), and laboratory parameters within normal range
- Negative alcohol and drug screens
- Females of childbearing potential who are sexually active with a nonsterilized male partner must use highly effective contraception
- Nonsterilized males who are sexually active with a female partner of childbearing potential must use highly effective contraception.
Key Exclusion Criteria
- Concurrent enrollment in another clinical study where the subject is receiving an investigational product
- Receipt of any marketed or investigational biologic agent within 4 months or 5 half-lives prior to screening, whichever is longer
- Receipt of any investigational nonbiologic agent within 3 months or 5 half-lives prior to screening, whichever is longer
- Current use of regular pain-modifying, anti-depressant, anxiolytic, or hypnotic medication
- History of thrombocytopenia or bleeding disorder or use of anticoagulants
- History of any immunodeficiency disorder or use of immunosuppressive medication.
- History of a clinically significant infection
- History of cancer
- Positive Hepatitis B or C
- Positive HIV
Data sourced from ClinicalTrials.gov (NCT02085473). 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.