A Study of DZD2269 in Healthy Adult Participants

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: DZD2269; Drug: placebo

• Registration Number: NCT04932005
• Lead Sponsor: Dizal Pharmaceuticals

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).

Study Timeline

• Study First Submitted: 2021-06-09
• Study First Submitted QC: 2021-06-09
• Study First Posted: 2021-06-18
• Study Start: 2021-06-29
• Primary Completion: 2022-04-01
• Study Completion: 2022-04-12
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-28
• Last Update Posted: 2022-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DZD2269	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.
Placebo	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.

Primary Outcome Measures

Name	Time	Method
Number and percentage of participants with adverse event (AE)	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)	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	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	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	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 Outcome Measures

Name	Time	Method
Maximum plasma concentration (Cmax) of DZD2269	After the first dose, 6 days for Part A; 7 days for Part C	To characterize pharmacokinetics of DZD2269 following oral administration in healthy participants
Drug concentrations of DZD2269 in plasma	After the first dose, 6 days for Part A; 7 days for Part C	To characterize pharmacokinetics of DZD2269 following oral administration in healthy participants
Area under the plasma concentration-time curve (AUC) of DZD2269	After the first dose, 6 days for Part A; 7days for Part C	To characterize pharmacokinetics of DZD2269 following oral administration in healthy participants

Trial Locations

Locations (1)

Frontage Clinical Service 200 Meadowlands Parkway; 🇺🇸 Secaucus, New Jersey, United States