Clinical trial NCT04446000: Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CSL730 in Healthy Adult Subjects
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CSL730 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Immune Complex-mediated Autoimmune Diseases
Lead sponsor: CSL Behring
Sponsor class: INDUSTRY
First posted: 2020-06-24
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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 by subcutaneous (SC) injection or SC infusion in healthy adult subjects.


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.

Primary outcomes:
measure: Number of subjects with treatment emergent adverse events (TEAEs) overall, by causality, and by severity
timeFrame: Within 96 hours and up to 56 days after CSL730 administration
measure: Percent of subjects with TEAEs overall, by causality, and by severity
timeFrame: Within 96 hours and up to 56 days after CSL730 administration
measure: Number of subjects with localized administration site AEs overall, by causality, and by severity
timeFrame: Within 96 hours and up to 56 days after CSL730 administration
measure: Percent of subjects with localized administration site AEs overall, by causality, and by severity
timeFrame: Within 96 hours and up to 56 days after CSL730 administration
Secondary outcomes:
measure: Maximum concentration (Cmax) for CSL730 in serum samples
timeFrame: up to 56 days after CSL730 administration
measure: Area under the concentration-time curve from time 0 to the last quantifiable time point (AUC0-last) for CSL730 in serum samples
timeFrame: up to 56 days after CSL730 administration
measure: Area under the concentration-time curve from time 0 extrapolated to time infinity (AUC0-inf) for CSL730 in serum samples
timeFrame: up to 56 days after CSL730 administration
measure: Time of maximum concentration (Tmax) for CSL730 in serum samples
timeFrame: up to 56 days after CSL730 administration
measure: Terminal elimination half-life (T1/2) for CSL730 in serum samples
timeFrame: up to 56 days after CSL730 administration
measure: Apparent total systemic clearance (CL/F) for CSL730 in serum samples
timeFrame: up to 56 days after CSL730 administration
measure: Apparent volume of distribution during the elimination phase (Vz/F) for CSL730 in serum samples
timeFrame: up to 56 days after CSL730 administration
measure: Levels of anti-CSL730 antibodies detected in serum samples
timeFrame: Days 15, 29, and 56
Other outcomes:
Locations:
city: Harrow
country: United Kingdom
facility: PAREXEL Early Phase Clinical Unit (London), Northwick Park Hospital
Study officials:
affiliation: CSL Behring
name: Study Director
role: STUDY_DIRECTOR
References: