Immune Complex-mediated Autoimmune DiseasesPhase 1NCT04446000
Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CSL730 in Healthy Adult Subjects
A Phase 1 study testing CSL730 in people with Immune Complex-mediated Autoimmune Diseases, run by CSL Behring at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Immune Complex-mediated Autoimmune Diseases
- What is being tested?
- CSL730
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Sep 2020to 28 Mar 2023
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
PAREXEL Early Phase Clinical Unit (London), Northwick Park Hospital
Harrow, HA1 3UJ
About this study
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
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.
- Being tested
- CSL730, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSL730Biological
Also called Recombinant trivalent human IgG1 Fc multimer
solution for injection and infusion
PlaceboDrug
A solution matching the excipient profile of CSL730 without the active substance
| Study group | Role | What they receive |
|---|---|---|
| CSL730 (dose 1 with premedication) | Experimental | administered as a single dose by subcutaneous (SC) injection or by SC infusion Receives: Biological: CSL730 |
| CSL730 (dose 2 with premedication) | Experimental | administered as a single dose by SC injection or by SC infusion Receives: Biological: CSL730 |
| CSL730 (dose 3 with premedication) | Experimental | administered as a single dose by SC injection or by SC infusion Receives: Biological: CSL730 |
| CSL730 (dose 1 without premedication) | Experimental | administered as a single dose by SC injection or by SC infusion Receives: Biological: CSL730 |
| CSL730 (dose 2 without premedication) | Experimental | administered as a single dose by SC injection or by SC infusion Receives: Biological: CSL730 |
| CSL730 (dose 3 without premedication) | Experimental | administered as a single dose by SC injection or by SC infusion Receives: Biological: CSL730 |
| CSL730 (dose 4 without premedication) | Experimental | administered as a single dose by SC injection or by SC infusion Receives: Biological: CSL730 |
| CSL730 (dose 5 without premedication) | Experimental | administered as a single dose by SC injection or by SC infusion Receives: Biological: CSL730 |
| CSL730 (dose 6 without premedication) | Experimental | administered as a single dose by SC injection or by SC infusion Receives: Biological: CSL730 |
| CSL730 (dose 7 without premedication) | Experimental | administered as a single dose by SC injection or by SC infusion Receives: Biological: CSL730 |
| Placebo | Placebo comparator | A solution matching the excipient profile of CSL730 without the active substance administered as a single dose by SC injection or by SC infusion Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with treatment emergent adverse events (TEAEs) overall, by causality, and by severity
Measured: Within 96 hours and up to 56 days after CSL730 administration
Percent of subjects with TEAEs overall, by causality, and by severity
Measured: Within 96 hours and up to 56 days after CSL730 administration
Number of subjects with localized administration site AEs overall, by causality, and by severity
Measured: Within 96 hours and up to 56 days after CSL730 administration
Percent of subjects with localized administration site AEs overall, by causality, and by severity
Measured: Within 96 hours and up to 56 days after CSL730 administration
Secondary outcomes (8)
Maximum concentration (Cmax) for CSL730 in serum samples
Measured: up to 56 days after CSL730 administration
Area under the concentration-time curve from time 0 to the last quantifiable time point (AUC0-last) for CSL730 in serum samples
Measured: up to 56 days after CSL730 administration
Area under the concentration-time curve from time 0 extrapolated to time infinity (AUC0-inf) for CSL730 in serum samples
Measured: up to 56 days after CSL730 administration
Time of maximum concentration (Tmax) for CSL730 in serum samples
Measured: up to 56 days after CSL730 administration
Terminal elimination half-life (T1/2) for CSL730 in serum samples
Measured: up to 56 days after CSL730 administration
Apparent total systemic clearance (CL/F) for CSL730 in serum samples
Measured: up to 56 days after CSL730 administration
Apparent volume of distribution during the elimination phase (Vz/F) for CSL730 in serum samples
Measured: up to 56 days after CSL730 administration
Levels of anti-CSL730 antibodies detected in serum samples
Measured: Days 15, 29, and 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2020
- Study start23 Sep 2020
- Primary completion28 Mar 2023
- Study completion28 Mar 2023
Why it stopped: Lack of clinical viability
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune Complex-mediated Autoimmune DiseasesStudies 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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSL Behring
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, CSL Behring
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04446000
- Sponsor's protocol ID
- CSL730_1002
- Other IDs
- 2019-001940-23, 2019
- Status last verified
- Nov 2023
- First submitted
- 22 Jun 2020
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: CSL will consider requests to share Individual Patient Data (IPD) from systematic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com. Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD. If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04446000
- Acronym / sponsor ID
- CSL730_1002
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of clinical viability
- Enrolment
- 52 participants (actual)
- Lead sponsor
- CSL BehringIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2020 (actual)
- Primary completion
- 28 Mar 2023 (actual)
- Study completion
- 28 Mar 2023 (actual)
- First posted
- 24 Jun 2020 (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.
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.
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 |
|---|---|---|
| CSL730 (dose 1 with premedication) | Experimental | Biological: CSL730administered as a single dose by subcutaneous (SC) injection or by SC infusion |
| CSL730 (dose 2 with premedication) | Experimental | Biological: CSL730administered as a single dose by SC injection or by SC infusion |
| CSL730 (dose 3 with premedication) | Experimental | Biological: CSL730administered as a single dose by SC injection or by SC infusion |
| CSL730 (dose 1 without premedication) | Experimental | Biological: CSL730administered as a single dose by SC injection or by SC infusion |
| CSL730 (dose 2 without premedication) | Experimental | Biological: CSL730administered as a single dose by SC injection or by SC infusion |
| CSL730 (dose 3 without premedication) | Experimental | Biological: CSL730administered as a single dose by SC injection or by SC infusion |
| CSL730 (dose 4 without premedication) | Experimental | Biological: CSL730administered as a single dose by SC injection or by SC infusion |
| CSL730 (dose 5 without premedication) | Experimental | Biological: CSL730administered as a single dose by SC injection or by SC infusion |
| CSL730 (dose 6 without premedication) | Experimental | Biological: CSL730administered as a single dose by SC injection or by SC infusion |
| CSL730 (dose 7 without premedication) | Experimental | Biological: CSL730administered as a single dose by SC injection or by SC infusion |
| Placebo | Placebo comparator | Drug: PlaceboA solution matching the excipient profile of CSL730 without the active substance administered as a single dose by SC injection or by SC infusion |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| CSL730Also: Recombinant trivalent human IgG1 Fc multimersolution for injection and infusion | Biological | CSL730 (dose 1 with premedication), CSL730 (dose 1 without premedication), CSL730 (dose 2 with premedication), CSL730 (dose 2 without premedication), CSL730 (dose 3 with premedication), CSL730 (dose 3 without premedication), CSL730 (dose 4 without premedication), CSL730 (dose 5 without premedication), CSL730 (dose 6 without premedication), CSL730 (dose 7 without premedication) |
| PlaceboA solution matching the excipient profile of CSL730 without the active substance | Drug | Placebo |
Primary outcome
Number of subjects with treatment emergent adverse events (TEAEs) overall, by causality, and by severity
Time frame: Within 96 hours and up to 56 days after CSL730 administration
Percent of subjects with TEAEs overall, by causality, and by severity
Time frame: Within 96 hours and up to 56 days after CSL730 administration
Number of subjects with localized administration site AEs overall, by causality, and by severity
Time frame: Within 96 hours and up to 56 days after CSL730 administration
Percent of subjects with localized administration site AEs overall, by causality, and by severity
Time frame: Within 96 hours and up to 56 days after CSL730 administration
8 secondary outcomes
Maximum concentration (Cmax) for CSL730 in serum samples
Time frame: up to 56 days after CSL730 administration
Area under the concentration-time curve from time 0 to the last quantifiable time point (AUC0-last) for CSL730 in serum samples
Time frame: up to 56 days after CSL730 administration
Area under the concentration-time curve from time 0 extrapolated to time infinity (AUC0-inf) for CSL730 in serum samples
Time frame: up to 56 days after CSL730 administration
Time of maximum concentration (Tmax) for CSL730 in serum samples
Time frame: up to 56 days after CSL730 administration
Terminal elimination half-life (T1/2) for CSL730 in serum samples
Time frame: up to 56 days after CSL730 administration
Apparent total systemic clearance (CL/F) for CSL730 in serum samples
Time frame: up to 56 days after CSL730 administration
Apparent volume of distribution during the elimination phase (Vz/F) for CSL730 in serum samples
Time frame: up to 56 days after CSL730 administration
Levels of anti-CSL730 antibodies detected in serum samples
Time frame: Days 15, 29, and 56
Results and safety
The study was stopped early (reason given: Lack of clinical viability). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Individual participant dataSharing planned: Yes. CSL will consider requests to share Individual Patient Data (IPD) from systematic review groups or bona-fide researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact CSL at clinicaltrials@cslbehring.com. Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD. If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.
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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
CSL Behring
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 CSL730 in people with Immune Complex-mediated Autoimmune Diseases, run by CSL Behring at 1 site in United Kingdom.
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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 29 Nov 2023. 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 United Kingdom. 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 was stopped early (reason given: Lack of clinical viability). Results are not available in the source record.
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 subjects with treatment emergent adverse events (TEAEs) overall, by causality, and by severity (time frame: Within 96 hours and up to 56 days after CSL730 administration). The study lists 4 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 29 Nov 2023.