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A Study to Investigate the Safety and Tolerability of Single and Multiple Ascending Doses of KIT2014 in Healthy Subjects
This is the first-in-human study with KIT2014 designed to provide safety, tolerability and pharmacokinetic data in healthy volunteers.
Study details:
This is a double-blind, randomised, placebo-controlled study to assess the safety, tolerability, and pharmacokinetics of ascending doses of inhaled KIT2014 administered via nebulizer to healthy adult participants. The study will be conducted in 2 parts, Part A (single ascending dose, SAD) and Part B (multiple ascending doses, MAD).
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : Yes
Gender eligible for study: All
Things to know
Study dates
Study start: 2024-10-16
Primary completion: 2025-03-31
Study completion finish: 2025-04-30
Study type
TREATMENT
Phase
PHASE1
Trial ID
NCT06659757
Intervention or treatment
DRUG: KIT2014
OTHER: Placebo
Conditions
- • Cystic Fibrosis
Find a site
Closest Location:
CMAX Clinical Research Pty Ltd
Research sites nearby
Select from list below to view details:
CMAX Clinical Research Pty Ltd
Adelaide, South Australia, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Part A: Single Ascending Dose (SAD)
| DRUG: KIT2014
|
EXPERIMENTAL: Part B: Multiple Ascending Dose (MAD)
| DRUG: KIT2014
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) | Incidence, type, severity, and relationship of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) after single and multiple inhaled administration of KIT2014 in healthy male and female participants. | Up to 10 days post-dose in SAD and up to 14 days after the last dose in MAD |
Secondary outcome
Frequently Asked Questions
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