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

CSL Behring

Status and phase

Terminated

Phase 1

Conditions

Immune Complex-mediated Autoimmune Diseases

Treatments

Biological: CSL730

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04446000

2019-001940-23 (EudraCT Number)

CSL730_1002

Details and patient eligibility

About

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.

Enrollment

52 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Quadruple Blind

52 participants in 11 patient groups, including a placebo group

CSL730 (dose 1 with premedication)

Experimental group

Description:

administered as a single dose by subcutaneous (SC) injection or by SC infusion

Treatment:

Biological: CSL730

CSL730 (dose 2 with premedication)

Experimental group

Description: