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DZD2269 for Healthy Subjects
Phase 1
Waitlist Available
Led By Frank Lee, MD
Research Sponsored by Dizal Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening until 5 days after the last dose (up to 34 days for part a, 40 days for part c)
Awards & highlights
Study Summary
This study is evaluating how safe the study drug is and how well it is tolerated after dosing.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from screening until 5 days after the last dose (up to 34 days for part a, 40 days for part c)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening until 5 days after the last dose (up to 34 days for part a, 40 days for part c)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number and percentage of participants with adverse event (AE)
Number and percentage of participants with clinically defined ECG abnormalities
Number and percentage of participants with clinically defined abnormal laboratory values
+2 moreSecondary outcome measures
Area under the plasma concentration-time curve (AUC) of DZD2269
Drug concentrations of DZD2269 in plasma
Maximum plasma concentration (Cmax) of DZD2269
Other outcome measures
Concentration of DZD2269 in urine
Percent of Phosphorylated cAMP (Adenosine 3'5' Cyclic Monophosphate)-Response Element Binding protein (pCREB) inhibition in T cells
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: DZD2269Experimental Treatment1 Intervention
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.
Group II: PlaceboPlacebo Group1 Intervention
In Part A, a single oral dose of placebo will be given. In Part C, placebo will be given twice daily for 7 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DZD2269
2021
Completed Phase 1
~80
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Dizal PharmaceuticalsLead Sponsor
20 Previous Clinical Trials
1,977 Total Patients Enrolled
Frank Lee, MDPrincipal InvestigatorFrontage Clinical Services, Inc.
7 Previous Clinical Trials
425 Total Patients Enrolled
Tracy Gregory, MDStudy DirectorFrontage Clinical Services, Inc.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
New Jersey
New York
How old are they?
18 - 65
What site did they apply to?
Frontage Clinical Service 200 Meadowlands Parkway
What portion of applicants met pre-screening criteria?
Met criteria
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