Immune Complex-mediated Autoimmune Diseases Clinical Trial
Official title:
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CSL730 in Healthy Adult Subjects
| Verified date | November 2023 |
| Source | CSL Behring |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 52 |
| Est. completion date | March 28, 2023 |
| Est. primary completion date | March 28, 2023 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 55 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | PAREXEL Early Phase Clinical Unit (London), Northwick Park Hospital | Harrow |
| Lead Sponsor | Collaborator |
|---|---|
| CSL Behring |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | ||
| Primary | Percent of subjects with TEAEs overall, by causality, and by severity | Within 96 hours and up to 56 days after CSL730 administration | ||
| Primary | 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 | ||
| Primary | 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 | Maximum concentration (Cmax) for CSL730 in serum samples | up to 56 days after CSL730 administration | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | Time of maximum concentration (Tmax) for CSL730 in serum samples | up to 56 days after CSL730 administration | ||
| Secondary | Terminal elimination half-life (T1/2) for CSL730 in serum samples | up to 56 days after CSL730 administration | ||
| Secondary | Apparent total systemic clearance (CL/F) for CSL730 in serum samples | up to 56 days after CSL730 administration | ||
| Secondary | Apparent volume of distribution during the elimination phase (Vz/F) for CSL730 in serum samples | up to 56 days after CSL730 administration | ||
| Secondary | Levels of anti-CSL730 antibodies detected in serum samples | Days 15, 29, and 56 |