Nemolizumab
DrugNemolizumab with Auto-Injector (AI).
NCT Number: NCT05405985
This study was to compare the rate and extent of absorption of a single dose of nemolizumab administered with auto-injectors [AI] (test) versus dual-chamber syringes [DCS] (reference) under controlled conditions in healthy adult subjects.
Looking for future studies?
Notify Me18 year–65 year
All sexes
Interventional
Phase 1
Galderma Investigational Site 7024, Tempe, Arizona, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Nemolizumab with Auto-Injector (AI).
Time frame: Pre-dose, 12 hours, 24 hours, Days 3, 4, 5, 6, 7, 8, 9, 10, 11, 15, 22, 29, 36, 43, 50, 57, 71, and 85 post-dose
Cmax was defined as the observed maximum serum concentration of nemolizumab. Cmax was used to measure the rate of absorption of nemolizumab.
Time frame: Pre-dose, 12 hours, 24 hours, Days 3, 4, 5, 6, 7, 8, 9, 10, 11, 15, 22, 29, 36, 43, 50, 57, 71, and 85 post-dose
AUC0-inf was defined as area under the plasma concentration-time curve from time 0 to infinity according to the equation: AUC0-inf = AUClast + Clast/λz; where λz = slope of the regression line of the terminal phase of the plasma concentration versus time curve, in semi-logarithmic scale; and Clast = last measurable drug concentration.
Time frame: Pre-dose, 12 hours, 24 hours, Days 3, 4, 5, 6, 7, 8, 9, 10, 11, 15, 22 and 29 post-dose
AUC0-4 weeks was defined as area under the concentration-time curve from time 0 to 4 weeks after study drug administration calculated with the linear trapezoidal method.
Time frame: Pre-dose, 12 hours, 24 hours, Days 3, 4, 5, 6, 7, 8, 9, 10, 11, 15, 22, 29, 36, 43, 50, 57, 71, and 85 post-dose
AUC0-last was defined as area under the concentration-time curve from administration to the last observed concentration time t, calculated with the linear trapezoidal method.
Time frame: Pre-dose, 12 hours, 24 hours, Days 3, 4, 5, 6, 7, 8, 9, 10, 11, 15, 22, 29, 36, 43, 50, 57, 71, and 85 post-dose
Tmax was defined as the time taken to reach the maximum observed serum concentration.
Time frame: Pre-dose, 12 hours, 24 hours, Days 3, 4, 5, 6, 7, 8, 9, 10, 11, 15, 22, 29, 36, 43, 50, 57, 71, and 85 post-dose
t1/2 is defined as time required for the concentration of the drug to reach half of its original value.
Time frame: Pre-dose, Day 29 and 85 post-dose
ADA positive was defined as a sample that was evaluated as positive in both the ADA screening and confirmatory assays. ADA positive participants was defined as participants who had at least 1 positive ADA result.
Galderma R&D
Industry
A Randomized, Single-Dose, Open-Label, Parallel-Group Study in Healthy Volunteers to Assess the Relative Bioavailability of a Subcutaneous Dose of Nemolizumab When Administered With Auto-Injector Compared to Dual-Chamber Syringe
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06342713
Atopic Dermatitis, Autoimmune Diseases
Waitara, New South Wales, Australia
View Trial DetailsNCT06934980
Atopic Dermatitis, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Montreal, Quebec, Canada
View Trial DetailsNCT04903093
Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Dermatitis
New Haven, Connecticut, United States
View Trial DetailsNCT00757042
Atopic Dermatitis, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
View Trial Details