A Study to Assess the Pharmacokinetics and Safety of CSL312 in Healthy Japanese and Caucasian Adults

Healthy Volunteers Clinical Trial

Official title:

A 2-Part, Phase 1, Single Center, Open-label, Single Ascending Dose Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Subcutaneous and Intravenous CSL312 in Healthy Adult Japanese and Caucasian Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04580654
• Other study ID #: CSL312_1003
• Status: Completed
• Phase: Phase 1
• Start date: October 29, 2020
• Est. completion date: May 7, 2021

Study information

• Verified date: October 2022
• Source: CSL Behring
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This will be a 2- part, phase 1, open-label, single center, single ascending dose study to investigate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of subcutaneous (SC) and intravenous (IV) administration of CSL312 in healthy adult Japanese and Caucasian subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: May 7, 2021
• Est. primary completion date: May 7, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy Caucasian and Japanese male or female subjects 18 to 55 years old (inclusive) that meet the following criteria at Screening:

• Japanese subjects defined as being born in Japan, having not lived outside of Japan for more than 10 years, and having both parents and four grandparents who are of Japanese ancestry.

• Caucasian subjects, defined as having both parents and four grandparents descended from and of the peoples of Europe, the Middle East, or North Africa, who are body weight-matched (± 15%) 1:1 with Japanese subjects.

• Body weight in the range of = 50 kg and = 100 kg

• Body mass index of = 18 kg/m2 and = 30 kg/m2

Exclusion Criteria:

• Positive serology test for human immunodeficiency virus (HIV)-1 / 2 antibody, hepatitis B virus (HBV) surface antigen (HBsAg) or hepatitis C virus (HCV) antibody.

• Received any live viral or bacterial vaccinations within 8 weeks of Screening or is expected to receive any live virus or bacterial vaccinations during the study.

• Evidence of current active infection.

• Known malignancy or a history of malignancy in the past 5 years .

• Blood pressure or pulse rate measurements outside the normal range for the subject's age.

• Female subject of childbearing potential or fertile male subject either not using or not willing to use an acceptable method of contraception

• Pregnant, breastfeeding, or not willing to cease breastfeeding.

• Donation or loss of more than 500 mL of blood within 3 months, or donated plasma within 7 days

• History of clinically significant arterial or venous thrombosis, bleeding disorder, or any abnormal coagulation test result

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Biological:
• CSL312
Fully human immunoglobulin G4/lambda recombinant monoclonal antibody against Factor XIIa

Locations

Country	Name	City	State
United States	Anaheim Clinical Trials, LLC	Anaheim	California

Sponsors (1)

Lead Sponsor	Collaborator
CSL Behring

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum plasma concentration (Cmax) of CSL312 after subcutaneous dosing		Up to 85 days postdose
Primary	Area under the curve (AUC) from time 0 extrapolated to infinity (AUC0-inf) of CSL312 after subcutaneous dosing		Up to 85 days postdose
Secondary	Time to maximum concentration (Tmax) of CSL312 after subcutaneous dosing		Up to 85 days postdose
Secondary	Area under the concentration-time curve from time 0 to the last measurable concentration (AUC0-last) of CSL312 after subcutaneous dosing		Up to 85 days postdose
Secondary	Half-life (t1/2) of CSL312 after subcutaneous dosing		Up to 85 days postdose
Secondary	Apparent clearance (CL/F) of CSL312 after subcutaneous dosing		Up to 85 days postdose
Secondary	Apparent volume of distribution (Vz/F) of CSL312 after subcutaneous dosing		Up to 85 days postdose
Secondary	Cmax of CSL312 after intravenous dosing		Up to 85 days postdose
Secondary	Tmax of CSL312 after intravenous dosing		Up to 85 days postdose
Secondary	AUC0-last of CSL312 after intravenous dosing		Up to 85 days postdose
Secondary	AUC0-inf of CSL312 after intravenous dosing		Up to 85 days postdose
Secondary	t1/2 of CSL312 after intravenous dosing		Up to 85 days postdose
Secondary	Clearance (CL) of CSL312 after intravenous dosing		Up to 85 days postdose
Secondary	Volume of distribution (Vd) of CSL312 after intravenous dosing		Up to 85 days postdose
Secondary	Mean FXIIa-mediated kallikrein activity		Up to 85 days postdose
Secondary	Number of subjects experiencing adverse events (AEs)		Up to 85 days postdose
Secondary	Percentage of subjects experiencing AEs		Up to 85 days postdose
Secondary	Number of subjects experiencing serious adverse events (SAEs)		Up to 85 days postdose
Secondary	Percentage of subjects experiencing SAEs		Up to 85 days postdose
Secondary	Number of subjects experiencing adverse events of special interest (AESIs)		Up to 85 days postdose
Secondary	Percentage of subjects experiencing AESIs		Up to 85 days postdose
Secondary	Number of subjects experiencing Anti-CSL312 antibodies		Up to 85 days postdose
Secondary	Percentage of subjects experiencing Anti-CSL312 antibodies		Up to 85 days postdose
Secondary	Number of subjects with injection / infusion site reaction by severity		Up to 48 hours after start of infusion or injection
Secondary	Percentage of subjects with injection / infusion site reaction by severity		Up to 48 hours after start of infusion or injection