- 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
Immune Complex-mediated Autoimmune Diseases
Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CSL730 in Healthy Adult Subjects
NCT04446000 | Phase 1 | 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.
18 Years to 55 Years
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PAREXEL Early Phase Clinical Unit (London), Northwick Park Hospital
Harrow,United Kingdom,HA1 3UJ
Study Eligibility 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.