Study Stopped
Lack of clinical viability
Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CSL730 in Healthy Adult Subjects
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
2 other identifiers
interventional
52
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Sep 2020
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2020
CompletedFirst Posted
Study publicly available on registry
June 24, 2020
CompletedStudy Start
First participant enrolled
September 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 28, 2023
CompletedNovember 29, 2023
November 1, 2023
2.5 years
June 22, 2020
November 28, 2023
Conditions
Outcome Measures
Primary Outcomes (4)
Number of subjects with treatment emergent adverse events (TEAEs) overall, by causality, and by severity
Within 96 hours and up to 56 days after CSL730 administration
Percent of subjects with TEAEs overall, by causality, and by severity
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
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
Within 96 hours and up to 56 days after CSL730 administration
Secondary Outcomes (8)
Maximum concentration (Cmax) for CSL730 in serum samples
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
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
up to 56 days after CSL730 administration
Time of maximum concentration (Tmax) for CSL730 in serum samples
up to 56 days after CSL730 administration
Terminal elimination half-life (T1/2) for CSL730 in serum samples
up to 56 days after CSL730 administration
- +3 more secondary outcomes
Study Arms (11)
CSL730 (dose 1 with premedication)
EXPERIMENTALadministered as a single dose by subcutaneous (SC) injection or by SC infusion
CSL730 (dose 2 with premedication)
EXPERIMENTALadministered as a single dose by SC injection or by SC infusion
CSL730 (dose 3 with premedication)
EXPERIMENTALadministered as a single dose by SC injection or by SC infusion
CSL730 (dose 1 without premedication)
EXPERIMENTALadministered as a single dose by SC injection or by SC infusion
CSL730 (dose 2 without premedication)
EXPERIMENTALadministered as a single dose by SC injection or by SC infusion
CSL730 (dose 3 without premedication)
EXPERIMENTALadministered as a single dose by SC injection or by SC infusion
CSL730 (dose 4 without premedication)
EXPERIMENTALadministered as a single dose by SC injection or by SC infusion
CSL730 (dose 5 without premedication)
EXPERIMENTALadministered as a single dose by SC injection or by SC infusion
CSL730 (dose 6 without premedication)
EXPERIMENTALadministered as a single dose by SC injection or by SC infusion
CSL730 (dose 7 without premedication)
EXPERIMENTALadministered as a single dose by SC injection or by SC infusion
Placebo
PLACEBO COMPARATORA solution matching the excipient profile of CSL730 without the active substance administered as a single dose by SC injection or by SC infusion
Interventions
solution for injection and infusion
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CSL Behringlead
Study Sites (1)
PAREXEL Early Phase Clinical Unit (London), Northwick Park Hospital
Harrow, HA1 3UJ, United Kingdom
Study Officials
- STUDY DIRECTOR
Study Director
CSL Behring
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2020
First Posted
June 24, 2020
Study Start
September 23, 2020
Primary Completion
March 28, 2023
Study Completion
March 28, 2023
Last Updated
November 29, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- IPD requests may be submitted to CSL no earlier than 12 months after publication of the results of this study via an article made available on a public website.
- Access Criteria
- Requests may only be made by systematic review groups or bona-fide researchers whose proposed use of the IPD is non-commercial in nature and has been approved by an internal review committee. An IPD request will not be considered by CSL unless the proposed research question seeks to answer a significant and unknown medical science or patient care question as determined by CSL's internal review committee. The requesting party must execute an appropriate data sharing agreement before IPD will be made available.
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.