CMAX Clinical Research Pty Ltd
Adelaide, South Australia, 5000, Australia
NCT Number: NCT06659757
This is the first-in-human study with KIT2014 designed to provide safety, tolerability and pharmacokinetic data in healthy volunteers.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Adelaide, South Australia, 5000, Australia
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Major Inclusion Criteria:
Major Exclusion Criteria:
Other inclusion/exclusion eligibility criteria apply.
KIT2014 will be administered by inhalation with a nebuliser
Placebo will be administered by inhalation with a nebuliser
Time frame: Up to 10 days post-dose in SAD and up to 14 days after the last dose in MAD
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.
Kither Biotech Srl
Industry
A Single-Centre, Double-Blinded, Randomised, Placebo-Controlled Phase I Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of KIT2014 in Healthy Subjects.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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