Status:
COMPLETED
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of KPL-404 in Healthy Subjects
Lead Sponsor:
Kiniksa Pharmaceuticals, Ltd.
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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) dose...
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 a...
Eligibility Criteria
Inclusion
- Key
- Healthy subjects
- Body mass index (BMI) in the range of 18.0 - 32.0 kg/m2
- Key
Exclusion
- 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
Key Trial Info
Start Date :
October 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 2 2021
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04497662
Start Date
October 22 2019
End Date
March 2 2021
Last Update
May 4 2021
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
PPD Clinic
Austin, Texas, United States, 78744
2
Q-Pharm Pty Ltd
Herston, Queensland, Australia, 4006