← Back to Search

Monoclonal Antibodies

CSL312 for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by CSL Behring
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 85 days post-dose
Awards & highlights

Study Summary

This trial compares the bioavailability of a new drug when delivered via two different types of injectors.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 85 days post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 85 days post-dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the concentration-time curve (AUC) from time 0 extrapolated to infinite time (AUC0-inf) of CSL312
Maximum plasma concentration (Cmax) of CSL312
Secondary outcome measures
AUC from time 0 to the last measurable concentration (AUC0-last) of CSL312
Apparent clearance (CL/F) of CSL312
Apparent volume of distribution (Vz/F) of CSL312
+8 more

Side effects data

From 2022 Phase 3 trial • 64 Patients • NCT04656418
10%
Upper respiratory tract infection
8%
Headache
8%
Nasopharyngitis
5%
Visual impairment
5%
Diarrhoea
5%
Conjunctivitis
5%
Sinusitis
5%
Urinary tract infection
5%
Abdominal pain
5%
Back pain
5%
Oropharyngeal pain
5%
Gastrointestinal infection
3%
Pyrexia
3%
Injection site erythema
3%
Hereditary angioedema
100%
80%
60%
40%
20%
0%
Study treatment Arm
CSL312
Placebo

Trial Design

6Treatment groups
Experimental Treatment
Group I: CSL312 NSD ThighExperimental Treatment1 Intervention
CSL312 administered SC in the thigh via a prefilled syringe assembled to a NSD
Group II: CSL312 NSD ArmExperimental Treatment1 Intervention
CSL312 administered SC in the upper arm via a prefilled syringe assembled to a NSD
Group III: CSL312 NSD AbdomenExperimental Treatment1 Intervention
CSL312 administered SC in the abdomen via a prefilled syringe assembled to a needle safety device (NSD)
Group IV: CSL312 AI ThighExperimental Treatment1 Intervention
CSL312 administered SC in the thigh via a prefilled syringe assembled to an AI
Group V: CSL312 AI ArmExperimental Treatment1 Intervention
CSL312 administered SC in the upper arm via a prefilled syringe assembled to an AI
Group VI: CSL312 AI AbdomenExperimental Treatment1 Intervention
CSL312 administered subcutaneously (SC) in the abdomen via a prefilled syringe assembled to an autoinjector (AI)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CSL312
2022
Completed Phase 3
~320

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

CSL BehringLead Sponsor
194 Previous Clinical Trials
1,211,090 Total Patients Enrolled
Study DirectorStudy DirectorCSL Behring
1,209 Previous Clinical Trials
489,332 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
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
2022. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05306275.
~44 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top