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Trial record 8 of 11 for:    Kiniksa

Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of KPL-404 in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04497662
Recruitment Status : Completed
First Posted : August 4, 2020
Last Update Posted : May 4, 2021
Sponsor:
Information provided by (Responsible Party):
Kiniksa Pharmaceuticals, Ltd.

Brief Summary:
Phase 1, randomized, double-blind, placebo-controlled first-in-human study to investigate the safety, tolerability, PK and PD properties of single ascending intravenous (IV) and subcutaneous (SC) doses of KPL-404 in healthy subjects

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: KPL-404 Other: Matching Placebo Phase 1

Detailed Description:

This study includes 2 single ascending dose (SAD) parts; (Part A) IV SAD (up to 5 planned dose level cohorts) and Part B SC SAD (up to 3 planned dose level cohorts).

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official Title: A Phase 1 First-in-human Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Intravenous and Subcutaneous Doses of KPL-404 in Healthy Subjects
Actual Study Start Date : October 22, 2019
Actual Primary Completion Date : January 21, 2021
Actual Study Completion Date : March 2, 2021

Arm Intervention/treatment
Experimental: KPL-404 (IV Administration) Drug: KPL-404
humanized IgG4 monoclonal antibody

Other: Matching Placebo
Placebo

Experimental: KPL-404 (SC Administration) Drug: KPL-404
humanized IgG4 monoclonal antibody

Other: Matching Placebo
Placebo




Primary Outcome Measures :
  1. TEAEs following IV dosing [ Time Frame: Up to 65 days post dose ]
    After single ascending IV doses, number of subjects with treatment-emergent adverse events (TEAEs) in the KPL-404 dose-level cohorts compared with the (pooled) IV placebo group

  2. TEAEs following SC dosing [ Time Frame: Up to 65 days post dose ]
    After single ascending SC doses, number of subjects with treatment-emergent adverse events (TEAEs) in the KPL-404 dose-level cohorts compared with the (pooled) SC placebo group



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

Key Inclusion Criteria:

  • Healthy subjects
  • Body mass index (BMI) in the range of 18.0 - 32.0 kg/m2

Key Exclusion Criteria:

  • Poor peripheral venous access
  • Clinically-significant illness within 4 weeks of dose administration
  • Active or acute infection requiring systemic antibiotic treatment within 2 weeks prior to 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): NCT04497662


Locations
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United States, Texas
PPD Clinic
Austin, Texas, United States, 78744
Australia, Queensland
Q-Pharm Pty Ltd
Herston, Queensland, Australia, 4006
Sponsors and Collaborators
Kiniksa Pharmaceuticals, Ltd.
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Responsible Party: Kiniksa Pharmaceuticals, Ltd.
ClinicalTrials.gov Identifier: NCT04497662    
Other Study ID Numbers: KPL-404-C101
First Posted: August 4, 2020    Key Record Dates
Last Update Posted: May 4, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No