Trials Sponsors Conditions Drugs Pricing

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (2)

Maximum plasma concentration (Cmax) of CSL312
Up to 85 days post-dose
Area under the concentration-time curve (AUC) from time 0 extrapolated to infinite time (AUC0-inf) of CSL312
Up to 85 days post-dose

Secondary Outcomes (11)

Number and percentage of subjects experiencing adverse events (AEs)
Up to 85 days post-dose
Number and percentage of subjects experiencing serious adverse events (SAEs)
Up to 85 days post-dose
Number and percentage of subjects experiencing adverse events of special interest (AESIs)
Up to 85 days post-dose
Number and percentage of subjects developing Anti-CSL312 antibodies
Up to 85 days post-dose
Number and percentage of subjects with clinically significant laboratory abnormalities that are reported as AEs
Up to 85 days post-dose
+6 more secondary outcomes

Study Arms (6)

CSL312 AI Abdomen

EXPERIMENTAL

CSL312 administered subcutaneously (SC) in the abdomen via a prefilled syringe assembled to an autoinjector (AI)

Drug: CSL312

CSL312 AI Thigh

EXPERIMENTAL

CSL312 administered SC in the thigh via a prefilled syringe assembled to an AI

Drug: CSL312

CSL312 AI Arm

EXPERIMENTAL

CSL312 administered SC in the upper arm via a prefilled syringe assembled to an AI

Interventions

CSL312Drug

Factor XIIa antagonist monoclonal antibody for subcutaneous use

Also known as: Gardacimab

CSL312 AI AbdomenCSL312 AI ArmCSL312 AI ThighCSL312 NSD AbdomenCSL312 NSD ArmCSL312 NSD Thigh

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Healthy Male or female 18 to 55 years of age
Body weight in the range of ≥ 50 kg and ≤ 100 kg, with a body mass index (BMI) of ≥ 18 kg/m2 and ≤ 30 kg/m2

You may not qualify if:

Sponsors & Collaborators

CSL Behring
Industrylead

Study Sites (1)

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Study Officials

Study Director
CSL Behring
STUDY DIRECTOR

Enrollment

132 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: NONE
Purpose: OTHER
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 23, 2022

First Posted

April 1, 2022

Study Start

April 4, 2022

Actual (reported)

Primary Completion

A Study to Compare the Pharmacokinetics of CSL312 Administered by Prefilled Syringe Assembled to Autoinjector to the Pharmacokinetics Administered by Prefilled Syringe Assembled to Needle Safety Device in Healthy Subjects

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (11)

Study Arms (6)

CSL312 AI Abdomen

CSL312 AI Thigh

CSL312 AI Arm

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

CSL312 NSD Abdomen

CSL312 NSD Thigh

CSL312 NSD Arm

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (11)

Study Arms (6)

CSL312 AI Abdomen

CSL312 AI Thigh

CSL312 AI Arm

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

CSL312 NSD Abdomen

CSL312 NSD Thigh

CSL312 NSD Arm

Data Sharing

Source record

Locations