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.

1 Sites

52 Participants

TERMINATED

18 Years to 55 Years

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SUBMIT

PAREXEL Early Phase Clinical Unit (London), Northwick Park Hospital

Harrow,United Kingdom,HA13UJ

Study Eligibility Criteria

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.

Additional Studies

Additional studies can be found at ClinicalTrials.gov