Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CSL730 in Healthy Adult Subjects

• Status: Recruiting
• Trial end date: 2022-07-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: CSL Behring

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.