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Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CSL730 in Healthy Adult Subjects

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ClinicalTrials.gov Identifier: NCT04446000
Recruitment Status : Recruiting
First Posted : June 24, 2020
Last Update Posted : September 30, 2020
Sponsor:
Information provided by (Responsible Party):
CSL Behring

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.

Condition or disease Intervention/treatment Phase
Immune Complex-mediated Autoimmune Diseases Biological: CSL730 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : September 23, 2020
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Arm Intervention/treatment
Experimental: CSL730 (dose 1 with premedication)
administered as a single dose by subcutaneous (SC) injection or by SC infusion
Biological: CSL730
solution for injection and infusion
Other Name: Recombinant trivalent human IgG1 Fc multimer

Experimental: CSL730 (dose 2 with premedication)
administered as a single dose by SC injection or by SC infusion
Biological: CSL730
solution for injection and infusion
Other Name: Recombinant trivalent human IgG1 Fc multimer

Experimental: CSL730 (dose 3 with premedication)
administered as a single dose by SC injection or by SC infusion
Biological: CSL730
solution for injection and infusion
Other Name: Recombinant trivalent human IgG1 Fc multimer

Experimental: CSL730 (dose 1 without premedication)
administered as a single dose by SC injection or by SC infusion
Biological: CSL730
solution for injection and infusion
Other Name: Recombinant trivalent human IgG1 Fc multimer

Experimental: CSL730 (dose 2 without premedication)
administered as a single dose by SC injection or by SC infusion
Biological: CSL730
solution for injection and infusion
Other Name: Recombinant trivalent human IgG1 Fc multimer

Experimental: CSL730 (dose 3 without premedication)
administered as a single dose by SC injection or by SC infusion
Biological: CSL730
solution for injection and infusion
Other Name: Recombinant trivalent human IgG1 Fc multimer

Experimental: CSL730 (dose 4 without premedication)
administered as a single dose by SC injection or by SC infusion
Biological: CSL730
solution for injection and infusion
Other Name: Recombinant trivalent human IgG1 Fc multimer

Experimental: CSL730 (dose 5 without premedication)
administered as a single dose by SC injection or by SC infusion
Biological: CSL730
solution for injection and infusion
Other Name: Recombinant trivalent human IgG1 Fc multimer

Experimental: CSL730 (dose 6 without premedication)
administered as a single dose by SC injection or by SC infusion
Biological: CSL730
solution for injection and infusion
Other Name: Recombinant trivalent human IgG1 Fc multimer

Experimental: CSL730 (dose 7 without premedication)
administered as a single dose by SC injection or by SC infusion
Biological: CSL730
solution for injection and infusion
Other Name: Recombinant trivalent human IgG1 Fc multimer

Placebo Comparator: Placebo
A solution matching the excipient profile of CSL730 without the active substance administered as a single dose by SC injection or by SC infusion
Drug: Placebo
A solution matching the excipient profile of CSL730 without the active substance




Primary Outcome Measures :
  1. 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 ]
  2. Percent of subjects with TEAEs overall, by causality, and by severity [ Time Frame: Within 96 hours and up to 56 days after CSL730 administration ]
  3. 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 ]
  4. 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 ]

Secondary Outcome Measures :
  1. Maximum concentration (Cmax) for CSL730 in serum samples [ Time Frame: up to 56 days after CSL730 administration ]
  2. 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 ]
  3. 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 ]
  4. Time of maximum concentration (Tmax) for CSL730 in serum samples [ Time Frame: up to 56 days after CSL730 administration ]
  5. Terminal elimination half-life (T1/2) for CSL730 in serum samples [ Time Frame: up to 56 days after CSL730 administration ]
  6. Apparent total systemic clearance (CL/F) for CSL730 in serum samples [ Time Frame: up to 56 days after CSL730 administration ]
  7. Apparent volume of distribution during the elimination phase (Vz/F) for CSL730 in serum samples [ Time Frame: up to 56 days after CSL730 administration ]
  8. Levels of anti-CSL730 antibodies detected in serum samples [ Time Frame: Days 15, 29, and 56 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04446000


Contacts
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Contact: Trial Registration Coordinator 610-878-4000 clinicaltrials@cslbehring.com

Locations
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United Kingdom
PAREXEL Early Phase Clinical Unit (London), Northwick Park Hospital Recruiting
Harrow, United Kingdom, HA1 3UJ
Sponsors and Collaborators
CSL Behring
Investigators
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Study Director: Study Director CSL Behring
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Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT04446000    
Other Study ID Numbers: CSL730_1002
2019-001940-23 ( EudraCT Number )
First Posted: June 24, 2020    Key Record Dates
Last Update Posted: September 30, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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.

Supporting Materials: Study Protocol
Statistical Analysis Plan (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.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Autoimmune Diseases
Immune System Diseases