HealthyPhase 1NCT03375606
Assessing the Safety and Tolerability of CSL730 in Healthy Caucasian and Japanese Adults
A Phase 1 study testing CSL730 in people with Healthy, run by CSL Behring at 2 sites in 2 countries.
Trial summary
To assess the safety and tolerability of ascending doses of CSL730 after a single intravenous (IV) infusion in healthy Caucasian and Japanese subjects Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- 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
- 26 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 10 Jan 2018to 22 Jun 2020
- 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 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males or females (postmenopausal or surgically sterile only) aged ≥ 20 to ≤ 55 years and of Caucasian or Japanese descent
Who cannot join
- Evidence of a clinically significant medical condition, disorder, or disease as judged by Investigator and / or study Medical Monitor.
- History of asthma (with the exception of childhood asthma that has resolved), chronic obstructive pulmonary disease, or recurrent or current respiratory infections; splenectomy; or recurrent or current gastrointestinal infections.
- Evidence of active or latent tuberculosis.
- Known or suspected hypersensitivity to the IP, to any excipients of the IP, humanized monoclonal antibodies, or Fc fusion protein therapeutics.
- History, or current diagnosis, of substance use disorder.
- Any abnormal clinical laboratory values deemed clinically significant by the Investigator and / or study Medical Monitor.
Show all 9Show fewer
- Positive serology test result for human immunodeficiency virus antibody, hepatitis virus B surface antigen or hepatitis virus C antibody at Screening.
- Donation or loss of ≥ 480 mL of whole blood within 2 months or donation of plasma within 14 days before Day -1.
- Plans to participate in another investigational drug study while enrolled in this study, or has participated in any other investigational drug study in which they were known to have been administered a monoclonal antibody or biological IP within 4 months, any other investigational drug study within 60 days or > 3 investigational drug studies within 12 months before IP administration.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
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 Intravenous CSL730 in Healthy Caucasian and Japanese Subjects
To assess the safety and tolerability of ascending doses of CSL730 after a single intravenous (IV) infusion in healthy Caucasian and Japanese subjects
- Conditions
- Healthy
- 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 IV infusion
PlaceboOther
Saline solution for IV infusion
| Study group | Role | What they receive |
|---|---|---|
| CSL730 | Experimental | Not described Receives: Biological: CSL730 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects with adverse events overall, and by causality and severity
Measured: Up to 8 weeks after infusion
Secondary outcomes (8)
Maximum observed concentration (Cmax) of CSL730 in serum
Measured: Before study drug infusion and up to 56 days after the start of the infusion.
Area under the concentration-time curve from time 0 to the last collection time (AUC0-last) of CSL730 in serum
Measured: Before study drug infusion and up to 56 days after the start of the infusion.
Area under the concentration-time curve from time 0 extrapolated to time infinity (AUC0-inf) of CSL730 in serum
Measured: Before study drug infusion and up to 56 days after the start of the infusion.
Time of maximum observed concentration (Tmax) of CSL730 in serum
Measured: Before study drug infusion and up to 56 days after the start of the infusion.
Terminal elimination half-life (T1/2) of CSL730 in serum
Measured: Before study drug infusion and up to 56 days after the start of the infusion.
Total systemic clearance (CL) of CSL730 in serum
Measured: Before study drug infusion and up to 56 days after the start of the infusion.
Volume of distribution during the elimination phase (Vz) of CSL730 in serum
Measured: Before study drug infusion and up to 56 days after the start of the infusion.
Number of subjects with anti-CSL730 antibodies in serum
Measured: Before study drug infusion and up to 56 days after the start of the infusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start10 Jan 2018
- Primary completion22 Jun 2020
- Study completion22 Jun 2020
Why it stopped: The Sponsor decided to terminate this study in favor of development of subcutaneous administration.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSL Behring
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Program Director, Study director, CSL Behring
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03375606
- Sponsor's protocol ID
- CSL730_1001
- Other IDs
- 2017-003478-15, 2017
- Status last verified
- Jun 2021
- First submitted
- 13 Dec 2017
- Last updated
- 3 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2021. 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 Intravenous CSL730 in Healthy Caucasian and Japanese Subjects
- ClinicalTrials.gov ID
- NCT03375606
- Acronym / sponsor ID
- CSL730_1001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The Sponsor decided to terminate this study in favor of development of subcutaneous administration.
- Enrolment
- 26 participants (actual)
- Lead sponsor
- CSL BehringIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 22 Jun 2020 (actual)
- Study completion
- 22 Jun 2020 (actual)
- First posted
- 18 Dec 2017 (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.
To assess the safety and tolerability of ascending doses of CSL730 after a single intravenous (IV) infusion in healthy Caucasian and Japanese subjects
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CSL730 | Experimental | Biological: CSL730 |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy males or females (postmenopausal or surgically sterile only) aged ≥ 20 to ≤ 55 years and of Caucasian or Japanese descent
Key exclusion criteria (9 listed)
- Evidence of a clinically significant medical condition, disorder, or disease as judged by Investigator and / or study Medical Monitor.
- History of asthma (with the exception of childhood asthma that has resolved), chronic obstructive pulmonary disease, or recurrent or current respiratory infections; splenectomy; or recurrent or current gastrointestinal infections.
- Evidence of active or latent tuberculosis.
- Known or suspected hypersensitivity to the IP, to any excipients of the IP, humanized monoclonal antibodies, or Fc fusion protein therapeutics.
- History, or current diagnosis, of substance use disorder.
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 IV infusion | Biological | CSL730 |
| PlaceboSaline solution for IV infusion | Other | Placebo |
Primary outcome
Percentage of subjects with adverse events overall, and by causality and severity
Time frame: Up to 8 weeks after infusion
8 secondary outcomes
Maximum observed concentration (Cmax) of CSL730 in serum
Time frame: Before study drug infusion and up to 56 days after the start of the infusion.
Area under the concentration-time curve from time 0 to the last collection time (AUC0-last) of CSL730 in serum
Time frame: Before study drug infusion and up to 56 days after the start of the infusion.
Area under the concentration-time curve from time 0 extrapolated to time infinity (AUC0-inf) of CSL730 in serum
Time frame: Before study drug infusion and up to 56 days after the start of the infusion.
Time of maximum observed concentration (Tmax) of CSL730 in serum
Time frame: Before study drug infusion and up to 56 days after the start of the infusion.
Terminal elimination half-life (T1/2) of CSL730 in serum
Time frame: Before study drug infusion and up to 56 days after the start of the infusion.
Total systemic clearance (CL) of CSL730 in serum
Time frame: Before study drug infusion and up to 56 days after the start of the infusion.
Volume of distribution during the elimination phase (Vz) of CSL730 in serum
Time frame: Before study drug infusion and up to 56 days after the start of the infusion.
Number of subjects with anti-CSL730 antibodies in serum
Time frame: Before study drug infusion and up to 56 days after the start of the infusion.
Results and safety
The study was stopped early (reason given: The Sponsor decided to terminate this study in favor of development of subcutaneous administration.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2021.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Program Director study director
CSL Behring
2 sites in 2 countries: 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 Healthy, run by CSL Behring at 2 sites in 2 countries.
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 1 inclusion and 9 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 3 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands, 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: The Sponsor decided to terminate this study in favor of development of subcutaneous administration.). 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?
Percentage of subjects with adverse events overall, and by causality and severity (time frame: Up to 8 weeks after infusion). 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 Jun 2021.