Complement-mediated DisordersPhase 1NCT05937581
First-In-Human Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Escalating Single And Multiple Doses Of CSL040 In Healthy Subjects
A Phase 1 study testing CSL040 in people with Complement-mediated Disorders, run by CSL Behring at 1 site in Australia.
Trial summary
First-In-Human Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Escalating Single And Multiple Doses Of CSL040 In Healthy Subjects Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Complement-mediated Disorders
- What is being tested?
- CSL040
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteAustralia
- Study dates
- 28 Sep 2023to 4 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1.Male or female 18 to 64 years of age, inclusive, at Screening
- 2.Body weight in the range of greater than or equal to (≥) 50 kg and less than or equal to (≤) 100 kilogram (kg) , with a body mass index of ≥ 18 kilogram per meter square (kg/m2) and ≤ 30 kg/m2, at Screening
- 3.Judged as healthy by an Investigator after completion of a comprehensive clinical assessment
- 4.Capable of providing written informed consent and willing and able to adhere to all protocol requirements
- 5.Can understand the nature, scope, and possible consequences of the study and able to comply with study procedures, restrictions, and requirements
- 6. Able to provide proof of adequate vaccination (as determined by the Investigator) against meningococcal disease, including vaccination against meningococcal serogroup B and meningococcal serogroups A, C, W, and Y OR be willing to receive additional vaccinations against these serogroups per the Australian Immunisation Handbook
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- 7.Continuous nonsmoker who has not used nicotine- and tobacco-containing products for at least 30 days prior to the first dosing based on urine cotinine testing at Screening and Day-1
- 8.Able to provide proof of adequate vaccination (as determined by the Investigator) against Haemophilus influenzae type b, Pneumococcus OR be willing to receive additional vaccinations against these pathogens with the first dose at least 21 days before the first dose of CSL040
- 9.Able to provide proof of adequate vaccination (as determined by the Investigator) against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS_CoV-2) OR be willing to receive additional vaccination(s) to achieve adequate vaccination status at least 14 days before the first dose of CSL040. If there is proof of a recent SARS-CoV-2 infection (as determined by the Investigator) within 90 days of the first dose of CSL040, the requirement for a vaccination will follow the current local clinical practice
Who cannot join
- 1.Any individual at high risk of exposure to Neisseria meningitidis, including, but not limited to, health care workers, doctors, nurses, students working in a clinical setting, laboratory workers with exposure to N. meningitidis, individuals residing in a dormitory setting (eg, military workers), and childcare workers
- 2. Vaccination with any live replication-competent vaccine 90 days before Day 1 or planned vaccination with the same within 90 days after the last administration of CSL040
- 3.A positive test result for any of the following: hepatitis B screening, hepatitis C virus antibody, or human immunodeficiency virus-1/2 antibody
- 4.History concerning for a N. meningitidis infection
- 5.History of allergy or intolerance to Penicillin V, as well as to potential backup medications including azithromycin, ciprofloxacin, and ceftriaxone
- 6.History of unexplained, recurrent infection, life-threatening infection, or history that suggests any immunodeficiency (functional immunodeficiency), including asplenia / functional asplenia
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- 7.Infection requiring treatment with systemic antibiotics (IV and / or oral administration for more than 3 days) within the last 90 days prior to dosing
- 8.Clinical evidence of current active serious infection, including any localized infection, or any infection which makes participation in this study unacceptably high risk
- 9.Blood pressure or pulse rate measurements outside the normal range for the subject's age and assessed as clinically significant
- 10.Known history of severe hypersensitivity reactions or suspected hypersensitivity to CSL040 or any excipients including polysorbate 80, monoclonal antibodies, or any documented history of a severe allergic reaction (in the opinion of the Investigator), angioedema, or anaphylaxis to food or any other drugs.
- 11.Subject has any condition that may compromise their safety or compliance, impede successful conduct of the study, interfere with interpretation of the results or would otherwise render the subject unsuitable for participation in the study
- 12.A positive test result for drugs of abuse (including alcohol) and cotinine at Screening and / or Day -1.
- 13.Weekly alcohol intake of > 10 units for females and > 14 units for males during the 3 months before Day -1.
- 14.Any values above the upper limit of normal (ULN) for alanine aminotransaminase (ALT) or aspartate aminotransaminase (AST), or bilirubin test result
- 15.Use of prescription or over-the-counter medication, herbal and dietary supplements, and vitamins and minerals (except any vaccinations or other medications required/permitted as per protocol) within the 21 days before first administration of investigational product
- 16.Female subject of childbearing potential or fertile male subject who are neither using nor willing to use a highly effective method of contraception
- 17.Pregnant, lactating, or breastfeeding
- 18.Donation or loss of more than 500 milliLiter (mL) of blood within 3 months, or donation of plasma within 7 days, before admission to the unit or plans to donate blood or plasma and for 5 half-lives of the last dose of CSL040 or until the end of the study, whichever is longer
- 19.Any planned surgical procedures during the study period
- 20.Participation in any other investigational product study in which receipt of an investigational product occurred within 5 half-lives or 28 days (whichever is longer) before dosing of investigational product, or participation in more than 4 clinical studies involving administration of an investigational product within the last 12 months before Screening
- 21.Subject who met all eligibility criteria but was not needed (ie, alternate subjects). Alternate subjects are eligible to participate in subsequent cohorts
- 22. Prior dosing with CSL040
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Double-Blind (Sponsor-Unblinded), Placebo-Controlled, Dose Escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Single And Multiple Doses Of CSL040 In Healthy Adult Subjects
First-In-Human Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Escalating Single And Multiple Doses Of CSL040 In Healthy Subjects
- Conditions
- Complement-mediated Disorders
- Being tested
- CSL040, Placebo
- Keywords
- Complement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSL040Drug
IV Administration
PlaceboDrug
0.9% w/v NaCI, IV Administration
| Study group | Role | What they receive |
|---|---|---|
| Part A [Single ascending dose (SAD)]: CSL040 (minimum dose) | Experimental | Single Intravenous (IV) Administration Receives: Drug: CSL040 |
| Part A (SAD): CSL040 (lower dose) | Experimental | Single IV Administration Receives: Drug: CSL040 |
| Part A (SAD): CSL040 (low dose) | Experimental | Single IV Administration Receives: Drug: CSL040 |
| Part A (SAD): CSL040 (medium dose) | Experimental | Single IV Administration Receives: Drug: CSL040 |
| Part A (SAD): CSL040 (medium-high dose) | Experimental | Single IV Administration Receives: Drug: CSL040 |
| Part A (SAD): CSL040 (maximum dose) | Experimental | Single IV Administration Receives: Drug: CSL040 |
| Part A (SAD): Placebo | Placebo comparator | Single IV Administration Receives: Drug: Placebo |
| Part B [Multiple ascending dose (MAD)]: CSL040 (minimum dose) | Experimental | IV Administration not to exceed 5 doses over 14 days Receives: Drug: CSL040 |
| Part B (MAD): CSL040 (medium dose) | Experimental | IV Administration not to exceed 5 doses over 14 days Receives: Drug: CSL040 |
| Part B (MAD): CSL040 (high dose) | Experimental | IV Administration not to exceed 5 doses over 14 days Receives: Drug: CSL040 |
| Part B (MAD): Placebo | Placebo comparator | IV Administration not to exceed 5 doses over 14 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment emergent adverse events (TEAEs), adverse events of special interests (AESIs), and serious adverse events (SAEs)
Measured: Part A (SAD): Up to 105 days; Part B (MAD): Up to 174 days
Percentages of participants with TEAEs, AESIs, and SAEs
Measured: Part A (SAD): Up to 105 days; Part B (MAD): Up to 174 days
The Number of Clinically Significant Changes from Baseline in Clinical Laboratory Tests Reported as AE
Clinical laboratory tests include hematology, biochemistry, coagulation, and urinalysis collected during the study. The investigator determines if the changes in laboratory test results are clinically significant.
Measured: Baseline and up to 69 days
Number of participants with vital signs out of normal range
Blood pressure (systolic and diastolic), pulse rate, respiratory rate and tympanic temperature will be assessed.
Measured: Baseline and up to 69 days
Change from Baseline in corrected QT interval using Fridericia's formula (QTcF) values of triplicate electrocardiograms
Measured: Baseline and up to 69 days
Absolute values of QTcF on electrocardiograms
Measured: Baseline and up to 69 days
Number of participants with abnormal electrocardiogram findings
Measured: Baseline and up to 69 days
Secondary outcomes (21)
Part A (SAD): Maximum concentration (Cmax)
Measured: Up to 56 days
Part A (SAD): Time to reach maximum concentration (Tmax)
Measured: Up to 56 days
Part A (SAD): Time to Area under the concentration-time curve from time 0 to the last measurable concentration (AUC0-last)
Measured: Up to 56 days
Part A (SAD): Area under the concentration-time curve from time 0 to infinity (AUC0-infinity)
Measured: Up to 56 days
Part A (SAD): Total systemic clearance (CL)
Measured: Up to 56 days
Part A (SAD): Volume of distribution (V)
Measured: Up to 56 days
Part A (SAD): Terminal elimination half-life (T1/2)
Measured: Up to 56 days
Part B (MAD): Maximum concentration (Cmax)
Measured: Up to 69 days
Part B (MAD): Time to reach maximum concentration (Tmax)
Measured: Up to 69 days
Part B (MAD): Time to Area under the concentration-time curve in 1 dosing interval (AUCtau)
Measured: Up to 69 days
Part B (MAD): Accumulation index (accumulation ratio determined by the ratio of steady state AUCtau to single dose AUCtau)
Measured: Up to 69 days
Part B (MAD): Lowest concentration prior to dosing (Ctrough)
Measured: Up to 69 days
Part B (MAD): Total systemic clearance (CL)
Measured: Up to 69 days
Part B (MAD): Volume of distribution at steady state (Vss)
Measured: Up to 69 days
Part A (SAD) and Part B (MAD): Percent change from Baseline in pharmacodynamic (PD) parameters
Levels of Wieslab ex vivo pathway activity for classical, lectin and alternative complement pathways, CH50 (hemolysis of sheep erythrocytes) and ApH50 (hemolysis of rabbit erythrocytes) will be measured and for each PD parameter presented as percent change from baseline over time profiles.
Measured: Up to 56 days (Part A) and up to 69 days (Part B)
Part A (SAD) and Part B (MAD): Maximum percent change from Baseline (Emax) in PD parameters
Levels of Wieslab ex vivo pathway activity for classical, lectin and alternative complement pathways, CH50 and ApH50 will be measured and for each PD parameter the maximum percent change from Baseline (Emax) will be determined.
Measured: Up to 56 days (Part A) and up to 69 days (Part B)
Part A (SAD) and Part B (MAD): Time to maximum percent change from Baseline (TEmax) in PD parameters
Levels of Wieslab ex vivo pathway activity for classical, lectin and alternative complement pathways, CH50 and ApH50 will be measured and for each PD parameter the Time to maximum percent change from Baseline (TEmax) will be determined.
Measured: Up to 56 days (Part A) and up to 69 days (Part B)
Part A (SAD) and Part B (MAD): Time below Baseline in PD parameters
Levels of Wieslab ex vivo pathway activity for classical, lectin and alternative complement pathways, CH50 and ApH50 will be measured and for each PD parameter the Time below Baseline will be determined.
Measured: Up to 56 days (Part A) and up to 69 days (Part B)
Part A (SAD) and Part B (MAD): AUC below Baseline in PD parameters
Levels of Wieslab ex vivo pathway activity for classical, lectin and alternative complement pathways, CH50 and ApH50 will be measured and for each PD parameter the AUC below Baseline will be determined.
Measured: Up to 56 days (Part A) and up to 69 days (Part B)
Part A (SAD) and Part B (MAD): Number of serum samples with Positive antidrug antibodies (ADAs) binding to CSL040
Measured: Up to 56 days (Part A) and up to 69 days (Part B)
Part A (SAD) and Part B (MAD): Number of participants with presence of treatment-emergent ADAs
Measured: Up to 56 days (Part A) and up to 69 days (Part B)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2023
- Study start28 Sep 2023
- Primary completion4 Dec 2025
- Study completion4 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complement-mediated DisordersStudies of the same condition, open and under way.
- More trials run by CSL BehringThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSL Behring
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, CSLBehring LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05937581
- Sponsor's protocol ID
- CSL040_1001
- Status last verified
- Jan 2026
- First submitted
- 18 May 2023
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: CSL will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-Blind (Sponsor-Unblinded), Placebo-Controlled, Dose Escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Single And Multiple Doses Of CSL040 In Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT05937581
- Acronym / sponsor ID
- CSL040_1001
- Conditions
- Complement-mediated Disorders
- Keywords
- Complement
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- CSL BehringIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2023 (actual)
- Primary completion
- 4 Dec 2025 (actual)
- Study completion
- 4 Dec 2025 (actual)
- First posted
- 10 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
First-In-Human Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Escalating Single And Multiple Doses Of CSL040 In Healthy Subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Part A [Single ascending dose (SAD)]: CSL040 (minimum dose) | Experimental | Drug: CSL040Single Intravenous (IV) Administration |
| Part A (SAD): CSL040 (lower dose) | Experimental | Drug: CSL040Single IV Administration |
| Part A (SAD): CSL040 (low dose) | Experimental | Drug: CSL040Single IV Administration |
| Part A (SAD): CSL040 (medium dose) | Experimental | Drug: CSL040Single IV Administration |
| Part A (SAD): CSL040 (medium-high dose) | Experimental | Drug: CSL040Single IV Administration |
| Part A (SAD): CSL040 (maximum dose) | Experimental | Drug: CSL040Single IV Administration |
| Part A (SAD): Placebo | Placebo comparator | Drug: PlaceboSingle IV Administration |
| Part B [Multiple ascending dose (MAD)]: CSL040 (minimum dose) | Experimental | Drug: CSL040IV Administration not to exceed 5 doses over 14 days |
| Part B (MAD): CSL040 (medium dose) | Experimental | Drug: CSL040IV Administration not to exceed 5 doses over 14 days |
| Part B (MAD): CSL040 (high dose) | Experimental | Drug: CSL040IV Administration not to exceed 5 doses over 14 days |
| Part B (MAD): Placebo | Placebo comparator | Drug: PlaceboIV Administration not to exceed 5 doses over 14 days |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 1.Male or female 18 to 64 years of age, inclusive, at Screening
- 2.Body weight in the range of greater than or equal to (≥) 50 kg and less than or equal to (≤) 100 kilogram (kg) , with a body mass index of ≥ 18 kilogram per meter square (kg/m2) and ≤ 30 kg/m2, at Screening
- 3.Judged as healthy by an Investigator after completion of a comprehensive clinical assessment
- 4.Capable of providing written informed consent and willing and able to adhere to all protocol requirements
- 5.Can understand the nature, scope, and possible consequences of the study and able to comply with study procedures, restrictions, and requirements
Key exclusion criteria (22 listed)
- 1.Any individual at high risk of exposure to Neisseria meningitidis, including, but not limited to, health care workers, doctors, nurses, students working in a clinical setting, laboratory workers with exposure to N. meningitidis, individuals residing in a dormitory setting (eg, military workers), and childcare workers
- 2. Vaccination with any live replication-competent vaccine 90 days before Day 1 or planned vaccination with the same within 90 days after the last administration of CSL040
- 3.A positive test result for any of the following: hepatitis B screening, hepatitis C virus antibody, or human immunodeficiency virus-1/2 antibody
- 4.History concerning for a N. meningitidis infection
- 5.History of allergy or intolerance to Penicillin V, as well as to potential backup medications including azithromycin, ciprofloxacin, and ceftriaxone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CSL040IV Administration | Drug | Part A (SAD): CSL040 (low dose), Part A (SAD): CSL040 (lower dose), Part A (SAD): CSL040 (maximum dose), Part A (SAD): CSL040 (medium dose), Part A (SAD): CSL040 (medium-high dose), Part A [Single ascending dose (SAD)]: CSL040 (minimum dose), Part B (MAD): CSL040 (high dose), Part B (MAD): CSL040 (medium dose), Part B [Multiple ascending dose (MAD)]: CSL040 (minimum dose) |
| Placebo0.9% w/v NaCI, IV Administration | Drug | Part A (SAD): Placebo, Part B (MAD): Placebo |
Primary outcome
Number of participants with treatment emergent adverse events (TEAEs), adverse events of special interests (AESIs), and serious adverse events (SAEs)
Time frame: Part A (SAD): Up to 105 days; Part B (MAD): Up to 174 days
Percentages of participants with TEAEs, AESIs, and SAEs
Time frame: Part A (SAD): Up to 105 days; Part B (MAD): Up to 174 days
The Number of Clinically Significant Changes from Baseline in Clinical Laboratory Tests Reported as AE
Time frame: Baseline and up to 69 days
Clinical laboratory tests include hematology, biochemistry, coagulation, and urinalysis collected during the study. The investigator determines if the changes in laboratory test results are clinically significant.
Number of participants with vital signs out of normal range
Time frame: Baseline and up to 69 days
Blood pressure (systolic and diastolic), pulse rate, respiratory rate and tympanic temperature will be assessed.
Change from Baseline in corrected QT interval using Fridericia's formula (QTcF) values of triplicate electrocardiograms
Time frame: Baseline and up to 69 days
Absolute values of QTcF on electrocardiograms
Time frame: Baseline and up to 69 days
Number of participants with abnormal electrocardiogram findings
Time frame: Baseline and up to 69 days
21 secondary outcomes
Part A (SAD): Maximum concentration (Cmax)
Time frame: Up to 56 days
Part A (SAD): Time to reach maximum concentration (Tmax)
Time frame: Up to 56 days
Part A (SAD): Time to Area under the concentration-time curve from time 0 to the last measurable concentration (AUC0-last)
Time frame: Up to 56 days
Part A (SAD): Area under the concentration-time curve from time 0 to infinity (AUC0-infinity)
Time frame: Up to 56 days
Part A (SAD): Total systemic clearance (CL)
Time frame: Up to 56 days
Part A (SAD): Volume of distribution (V)
Time frame: Up to 56 days
Part A (SAD): Terminal elimination half-life (T1/2)
Time frame: Up to 56 days
Part B (MAD): Maximum concentration (Cmax)
Time frame: Up to 69 days
Part B (MAD): Time to reach maximum concentration (Tmax)
Time frame: Up to 69 days
Part B (MAD): Time to Area under the concentration-time curve in 1 dosing interval (AUCtau)
Time frame: Up to 69 days
Part B (MAD): Accumulation index (accumulation ratio determined by the ratio of steady state AUCtau to single dose AUCtau)
Time frame: Up to 69 days
Part B (MAD): Lowest concentration prior to dosing (Ctrough)
Time frame: Up to 69 days
Part B (MAD): Total systemic clearance (CL)
Time frame: Up to 69 days
Part B (MAD): Volume of distribution at steady state (Vss)
Time frame: Up to 69 days
Part A (SAD) and Part B (MAD): Percent change from Baseline in pharmacodynamic (PD) parameters
Time frame: Up to 56 days (Part A) and up to 69 days (Part B)
Part A (SAD) and Part B (MAD): Maximum percent change from Baseline (Emax) in PD parameters
Time frame: Up to 56 days (Part A) and up to 69 days (Part B)
Part A (SAD) and Part B (MAD): Time to maximum percent change from Baseline (TEmax) in PD parameters
Time frame: Up to 56 days (Part A) and up to 69 days (Part B)
Part A (SAD) and Part B (MAD): Time below Baseline in PD parameters
Time frame: Up to 56 days (Part A) and up to 69 days (Part B)
Part A (SAD) and Part B (MAD): AUC below Baseline in PD parameters
Time frame: Up to 56 days (Part A) and up to 69 days (Part B)
Part A (SAD) and Part B (MAD): Number of serum samples with Positive antidrug antibodies (ADAs) binding to CSL040
Time frame: Up to 56 days (Part A) and up to 69 days (Part B)
Part A (SAD) and Part B (MAD): Number of participants with presence of treatment-emergent ADAs
Time frame: Up to 56 days (Part A) and up to 69 days (Part B)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: Yes. CSL will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
CSLBehring LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CSL040 in people with Complement-mediated Disorders, run by CSL Behring at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment emergent adverse events (TEAEs), adverse events of special interests (AESIs), and serious adverse events (SAEs) (time frame: Part A (SAD): Up to 105 days; Part B (MAD): Up to 174 days). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.