Status:
TERMINATED
Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CSL730 in Healthy Adult Subjects
Lead Sponsor:
CSL Behring
Conditions:
Immune Complex-mediated Autoimmune Diseases
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 28 2023
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04446000
Start Date
September 23 2020
End Date
March 28 2023
Last Update
November 29 2023
Active Locations (1)
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1
PAREXEL Early Phase Clinical Unit (London), Northwick Park Hospital
Harrow, United Kingdom, HA1 3UJ