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OpenTrials
Completed

NCT Number: NCT04497662

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

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

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Q-Pharm Pty Ltd, Herston, Queensland, Australia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KPL-404

Drug

humanized IgG4 monoclonal antibody

Matching Placebo

Other

Placebo

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Kiniksa Pharmaceuticals, Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 4, 2020
Registry last updated
May 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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