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

Kiniksa Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Other: Matching Placebo; Drug: KPL-404

Study type: Interventional

Funder types: Industry

Identifiers

NCT04497662

KPL-404-C101

Details and patient eligibility

About

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

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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52 participants in 2 patient groups

KPL-404 (IV Administration)

Experimental group

Treatment:

Other: Matching Placebo

Drug: KPL-404

KPL-404 (SC Administration)

Experimental group

Treatment:

Other: Matching Placebo

Drug: KPL-404