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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: KPL-404; Other: Matching Placebo

• Registration Number: NCT04497662
• Lead Sponsor: 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

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 Timeline

• Study Start: 2019-10-22
• Study First Submitted: 2020-07-28
• Study First Submitted QC: 2020-07-30
• Study First Posted: 2020-08-04
• Primary Completion: 2021-01-21
• Study Completion: 2021-03-02
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-03
• Last Update Posted: 2021-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
KPL-404 (IV Administration)	KPL-404	-
KPL-404 (IV Administration)	Matching Placebo	-
KPL-404 (SC Administration)	KPL-404	-
KPL-404 (SC Administration)	Matching Placebo	-

Primary Outcome Measures

Name	Time	Method
TEAEs following IV dosing	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
TEAEs following SC dosing	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

Trial Locations

Locations (2)

Q-Pharm Pty Ltd; 🇦🇺 Herston, Queensland, Australia

PPD Clinic; 🇺🇸 Austin, Texas, United States