Immune Complex-mediated Autoimmune Diseases
Conditions
Brief summary
This phase 1, randomized, double-blind, placebo-controlled study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of CSL730 administered by subcutaneous (SC) injection or SC infusion in healthy adult subjects.
Interventions
BIOLOGICALCSL730
solution for injection and infusion
DRUGPlacebo
A solution matching the excipient profile of CSL730 without the active substance
Sponsors
CSL Behring
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male or female adult subjects aged ≥ 18 to ≤ 55 years * Females must be either postmenopausal or sterile * Body weight between ≥ 50 and ≤ 110 kg and body mass index between ≥ 18.0 kg/m2 and ≤ 30 kg/m2
Exclusion criteria
* History or current evidence of a clinically significant medical condition, disorder, or disease, including but not limited to any of the following: hepatic (hepatitis, cirrhosis, or history of liver disease, drug reaction, or aminotransaminase elevations, if known); biliary; renal; cardiac; bronchopulmonary; vascular; hematologic; gastrointestinal; allergy; endocrine / metabolic (diabetes, thyroid disorders, adrenal disease); neurologic (including history of migraine); psychiatric; immunologic; dermatologic; oncologic (subjects with resected cervical or skin cancer \[except melanoma\] who have had no evidence of disease in the last 5 years are eligible), that precludes designation of healthy subjects as judged by the Investigator * History or evidence of congenital or acquired immunosuppressive condition(s), including positive serology for human immunodeficiency virus infection or taking immunosuppressive agents. * Evidence of active or latent tuberculosis * Hospitalization within 3 months before IP administration or planned hospitalization at any time during the study. * History of any drug allergy, hypersensitivity (excluding hay fever) or intolerance to latex or any drug product * A positive test result for drugs of abuse. * Smokers within 3 months before Screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of subjects with treatment emergent adverse events (TEAEs) overall, by causality, and by severity | Within 96 hours and up to 56 days after CSL730 administration |
| Percent of subjects with TEAEs overall, by causality, and by severity | Within 96 hours and up to 56 days after CSL730 administration |
| Number of subjects with localized administration site AEs overall, by causality, and by severity | Within 96 hours and up to 56 days after CSL730 administration |
| Percent of subjects with localized administration site AEs overall, by causality, and by severity | Within 96 hours and up to 56 days after CSL730 administration |
Secondary
| Measure | Time frame |
|---|---|
| Terminal elimination half-life (T1/2) for CSL730 in serum samples | up to 56 days after CSL730 administration |
| Apparent total systemic clearance (CL/F) for CSL730 in serum samples | up to 56 days after CSL730 administration |
| Maximum concentration (Cmax) for CSL730 in serum samples | up to 56 days after CSL730 administration |
| Levels of anti-CSL730 antibodies detected in serum samples | Days 15, 29, and 56 |
| Apparent volume of distribution during the elimination phase (Vz/F) for CSL730 in serum samples | up to 56 days after CSL730 administration |
| Area under the concentration-time curve from time 0 to the last quantifiable time point (AUC0-last) for CSL730 in serum samples | up to 56 days after CSL730 administration |
| Area under the concentration-time curve from time 0 extrapolated to time infinity (AUC0-inf) for CSL730 in serum samples | up to 56 days after CSL730 administration |
| Time of maximum concentration (Tmax) for CSL730 in serum samples | up to 56 days after CSL730 administration |
Countries
United Kingdom
Outcome results
None listed