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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04497662




Registration number
NCT04497662
Ethics application status
Date submitted
28/07/2020
Date registered
4/08/2020
Date last updated
4/05/2021

Titles & IDs
Public title
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of KPL-404 in Healthy Subjects
Scientific 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
Secondary ID [1] 0 0
KPL-404-C101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - KPL-404
Other interventions - Matching Placebo

Experimental: KPL-404 (IV Administration) -

Experimental: KPL-404 (SC Administration) -


Treatment: Drugs: KPL-404
humanized IgG4 monoclonal antibody

Other interventions: Matching Placebo
Placebo

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
TEAEs following IV dosing - 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
Timepoint [1] 0 0
Up to 65 days post dose
Primary outcome [2] 0 0
TEAEs following SC dosing - 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
Timepoint [2] 0 0
Up to 65 days post dose

Eligibility
Key inclusion criteria
Key

- Healthy subjects

- Body mass index (BMI) in the range of 18.0 - 32.0 kg/m2

Key
Minimum age
18 Years
Maximum age
55 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Q-Pharm Pty Ltd - Herston
Recruitment postcode(s) [1] 0 0
4006 - Herston
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Kiniksa Pharmaceuticals, Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/show/NCT04497662
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications