Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of KPL-404 in Healthy Subjects
NCT ID: NCT04497662
Last Updated: 2021-05-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
52 participants
INTERVENTIONAL
2019-10-22
2021-03-02
Brief Summary
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Detailed Description
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Safety assessments will include adverse events (AEs), concomitant medications, clinical laboratory, vital signs, 12-lead electrocardiogram, and physical examination. Serial blood samples for PK, PD, and anti-drug antibodies will be performed during each part of the study during the Treatment and Safety Evaluation Period.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
OTHER
TRIPLE
Study Groups
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KPL-404 (IV Administration)
KPL-404
humanized IgG4 monoclonal antibody
Matching Placebo
Placebo
KPL-404 (SC Administration)
KPL-404
humanized IgG4 monoclonal antibody
Matching Placebo
Placebo
Interventions
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KPL-404
humanized IgG4 monoclonal antibody
Matching Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* Body mass index (BMI) in the range of 18.0 - 32.0 kg/m2
Exclusion Criteria
* Clinically-significant illness within 4 weeks of dose administration
* Active or acute infection requiring systemic antibiotic treatment within 2 weeks prior to Screening
18 Years
55 Years
ALL
Yes
Sponsors
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Kiniksa Pharmaceuticals, Ltd.
INDUSTRY
Responsible Party
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Locations
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PPD Clinic
Austin, Texas, United States
Q-Pharm Pty Ltd
Herston, Queensland, Australia
Countries
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Other Identifiers
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KPL-404-C101
Identifier Type: -
Identifier Source: org_study_id
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