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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04497662

Enrollment

Registered

2020-08-04

Start date

2019-10-22

Completion date

2021-03-02

Last updated

2021-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

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.

Interventions

DRUGKPL-404

humanized IgG4 monoclonal antibody

OTHERMatching Placebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

OTHER

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Australia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026