A Phase 1 Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of DZD2269 Oral Tablet Following Single and Multiple Ascending Dose Administration to Healthy Adult Participants
Overview
- Phase
- Phase 1
- Intervention
- DZD2269
- Conditions
- Healthy Volunteers
- Sponsor
- Dizal Pharmaceuticals
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Number and percentage of participants with adverse event (AE)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
DZD2269
This study includes two parts. In Part A, a single dose of DZD2269 at different dose levels will be given. In Part C, DZD2269 at selected dose levels will be given twice daily for 7 days.
Intervention: DZD2269
Placebo
In Part A, a single oral dose of placebo will be given. In Part C, placebo will be given twice daily for 7 days.
Intervention: placebo
Outcomes
Primary Outcomes
Number and percentage of participants with adverse event (AE)
Time Frame: From first dose until 5 days after the last dose (Up to 6 days for Part A; 12 days for Part C)
"To assess the safety and tolerability of DZD2269 versus placebo following oral administration"
Number and percentage of participants with serious adverse event (SAE)
Time Frame: From screening until 5 days after the last dose (Up to 34 days for Part A, 40 days for Part C)
To assess the safety and tolerability of DZD2269 versus placebo following oral administration
Number and percentage of participants with clinically defined abnormal laboratory values
Time Frame: From screening until 5 days after the last dose (Up to 34 days for Part A, 40 days for Part C)
To assess the safety and tolerability of DZD2269 versus placebo following oral administration
Number and percentage of participants with clinically defined ECG abnormalities
Time Frame: From screening until 5 days after the last dose (Up to 34 days for Part A, 40 days for Part C)
To assess the safety and tolerability of DZD2269 versus placebo following oral administration
Number and percentage of participants with clinically defined abnormal vital signs
Time Frame: From screening until 5 days after the last dose (Up to 34 days for Part A, 40 days for Part C)
To assess the safety and tolerability of DZD2269 versus placebo following oral administration
Secondary Outcomes
- Drug concentrations of DZD2269 in plasma(After the first dose, 6 days for Part A; 7 days for Part C)
- Maximum plasma concentration (Cmax) of DZD2269(After the first dose, 6 days for Part A; 7 days for Part C)
- Area under the plasma concentration-time curve (AUC) of DZD2269(After the first dose, 6 days for Part A; 7days for Part C)