NCT04497662

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Kiniksa Pharmaceuticals, Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	KPL-404	humanized IgG4 monoclonal antibody
OTHER	Matching Placebo	Placebo

Timeline

• Start date: 2019-10-22
• Primary completion: 2021-01-21
• Completion: 2021-03-02
• First posted: 2020-08-04
• Last updated: 2021-05-04

Locations

2 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study