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
Overview
- Phase
- Phase 1
- Intervention
- KPL-404
- Conditions
- Healthy Volunteers
- Sponsor
- Kiniksa Pharmaceuticals, Ltd.
- Enrollment
- 52
- Locations
- 2
- Primary Endpoint
- TEAEs following IV dosing
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy subjects
- •Body mass index (BMI) in the range of 18.0 - 32.0 kg/m2
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
Arms & Interventions
KPL-404 (IV Administration)
Intervention: KPL-404
KPL-404 (IV Administration)
Intervention: Matching Placebo
KPL-404 (SC Administration)
Intervention: KPL-404
KPL-404 (SC Administration)
Intervention: Matching Placebo
Outcomes
Primary Outcomes
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
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