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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04497662
• Other study ID #: KPL-404-C101
• Status: Completed
• Phase: Phase 1
• Start date: October 22, 2019
• Est. completion date: March 2, 2021

Study information

• Verified date: May 2021
• Source: Kiniksa Pharmaceuticals, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: March 2, 2021
• Est. primary completion date: January 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• KPL-404
humanized IgG4 monoclonal antibody

Other:
• Matching Placebo
Placebo

Locations

Country	Name	City	State
Australia	Q-Pharm Pty Ltd	Herston	Queensland
United States	PPD Clinic	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Kiniksa Pharmaceuticals, Ltd.

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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