Tralokinumab pharmacokinetics and tolerability when administered by different subcutaneous injection methods and rates
| Autor: | Nicholas J. White, Balaji Agoram, Diane V. Doughty, René van der Merwe, Xiaobai Li, Meena Jain, Corbin Clawson |
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| Rok vydání: | 2017 |
| Předmět: |
Adult
Male Erythema Visual analogue scale Injections Subcutaneous tralokinumab Pain Hemorrhage Pilot Projects 030226 pharmacology & pharmacy Young Adult 03 medical and health sciences Subcutaneous injection 0302 clinical medicine Hematoma Pharmacokinetics medicine Humans Single-Blind Method Pharmacology (medical) Anti-Asthmatic Agents tolerability Adverse effect Aged Pharmacology business.industry Antibodies Monoclonal asthma Middle Aged medicine.disease Healthy Volunteers Tolerability Anesthesia subcutaneous Female medicine.symptom business pharmacokinetics 030217 neurology & neurosurgery Research Article Tralokinumab |
| Zdroj: | International Journal of Clinical Pharmacology and Therapeutics |
| ISSN: | 0946-1965 |
| Popis: | Objective Tralokinumab, administered as two 1-mL subcutaneous injections every 2 weeks, at the target dose 300 mg, has been shown to improve lung function in patients with asthma. This study evaluated the pharmacokinetic (PK) and tolerability profile of tralokinumab 300 mg when administered by different rates of subcutaneous injection, as part of a pilot investigation of new injection regimens. Methods This phase I study randomized 60 healthy adults to receive 300 mg tralokinumab, as two 1-mL subcutaneous injections, each delivered over 10 seconds, or one 2-mL injection delivered over 10 seconds (12 mL/min), 1 minute (2 mL/min), or 12 minutes (0.167 mL/min). Results No differences in the PK profile of tralokinumab were observed between cohorts. Immediately following injection, injection-site pain intensity (mean (SD)) was lowest following 0.167 mL/min injection (5.1 mm (8.0) via visual analog scale (VAS)) and greatest following 12 mL/min injection (41 mm (27.7) via VAS); with mean injection-site pruritus intensity low for all participants. Two types of local injection-site reactions were observed: erythema (58.3%) and hematoma/bleeding (18.3%). All treatment-emergent adverse events were mild. Conclusions Tralokinumab 300 mg is well tolerated, with comparable PK, when administered by a single 2-mL injection at different rates of subcutaneous injection vs. two 1-mL injections. . |
| Databáze: | OpenAIRE |
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