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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: KPL-404; Other: Matching Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Herston, Queensland, Australia, 4006
      • Q-Pharm Pty Ltd
• United States
  • Texas
    • Austin, Texas, United States, 78744
      • PPD Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TEAEs following IV dosing	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	Up to 65 days post dose
TEAEs following SC dosing	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	Up to 65 days post dose

Collaborators and Investigators

• Sponsor: Kiniksa Pharmaceuticals, Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 22, 2019
• Primary Completion (ACTUAL): January 21, 2021
• Study Completion (ACTUAL): March 2, 2021

Study Registration Dates

• First Submitted: July 28, 2020
• First Submitted That Met QC Criteria: July 30, 2020
• First Posted (ACTUAL): August 4, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 4, 2021
• Last Update Submitted That Met QC Criteria: May 3, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: KPL-404-C101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No