This is a research study in healthy participants. The purpose of this study is to see how safe the study drug is and how well it is tolerated after dosing. This study will also investigate pharmacokinetics of DZD2269; renal excretion of DZD2269 will also be evaluated. The study will also measure biomarkers such as pCREB in the blood.
A phase 1, randomized, double-blinded, placebo-controlled, study in healthy participants. This study includes two parts, Part A (single ascending dose escalation) and Part C (multiple ascending dose escalation).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
72
Frontage Clinical Service 200 Meadowlands Parkway
Secaucus, New Jersey, United States
Number and percentage of participants with adverse event (AE)
"To assess the safety and tolerability of DZD2269 versus placebo following oral administration"
Time frame: From first dose until 5 days after the last dose (Up to 6 days for Part A; 12 days for Part C)
Number and percentage of participants with serious adverse event (SAE)
To assess the safety and tolerability of DZD2269 versus placebo following oral administration
Time frame: From screening until 5 days after the last dose (Up to 34 days for Part A, 40 days for Part C)
Number and percentage of participants with clinically defined abnormal laboratory values
To assess the safety and tolerability of DZD2269 versus placebo following oral administration
Time frame: From screening until 5 days after the last dose (Up to 34 days for Part A, 40 days for Part C)
Number and percentage of participants with clinically defined abnormal vital signs
To assess the safety and tolerability of DZD2269 versus placebo following oral administration
Time frame: From screening until 5 days after the last dose (Up to 34 days for Part A, 40 days for Part C)
Number and percentage of participants with clinically defined ECG abnormalities
To assess the safety and tolerability of DZD2269 versus placebo following oral administration
Time frame: From screening until 5 days after the last dose (Up to 34 days for Part A, 40 days for Part C)
Drug concentrations of DZD2269 in plasma
To characterize pharmacokinetics of DZD2269 following oral administration in healthy participants
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Time frame: After the first dose, 6 days for Part A; 7 days for Part C
Maximum plasma concentration (Cmax) of DZD2269
To characterize pharmacokinetics of DZD2269 following oral administration in healthy participants
Time frame: After the first dose, 6 days for Part A; 7 days for Part C
Area under the plasma concentration-time curve (AUC) of DZD2269
To characterize pharmacokinetics of DZD2269 following oral administration in healthy participants
Time frame: After the first dose, 6 days for Part A; 7days for Part C