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

• Sponsor: Kiniksa Pharmaceuticals, Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04497662
• Collaborator: (none)
• Enrollment: 52
• Locations: 2
• Arms: 2
• Actual Duration (Months): 16.3
• Patients Per Site: 26
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: KPL-404; Other: Matching Placebo	Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 52 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Other
• 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
• Actual Study Start Date: Oct 22, 2019
• Actual Primary Completion Date: Jan 21, 2021
• Actual Study Completion Date: Mar 2, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: KPL-404 (IV Administration)	Drug: KPL-404; humanized IgG4 monoclonal antibody; Other: Matching Placebo; Placebo
Experimental: KPL-404 (SC Administration)	Drug: KPL-404; humanized IgG4 monoclonal antibody; Other: Matching Placebo; Placebo

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	PPD Clinic	Austin	Texas	United States	78744
2	Q-Pharm Pty Ltd	Herston	Queensland	Australia	4006

Sponsors and Collaborators

• Kiniksa Pharmaceuticals, Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kiniksa Pharmaceuticals, Ltd.
• ClinicalTrials.gov Identifier: NCT04497662
• Other Study ID Numbers: KPL-404-C101
• First Posted: Aug 4, 2020
• Last Update Posted: May 4, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of May 4, 2021