DZD8586 Safety Study
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, DZD8586, to determine its safety and how the body processes it. Researchers will test the drug in humans for the first time, aiming to identify any side effects and how long the drug remains in the body. The trial will compare two groups: one receiving a single dose of DZD8586 and the other receiving a placebo (a harmless pill with no effect). The trial seeks healthy adults who have never smoked or have not smoked in over a year and meet certain health criteria. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Will I have to stop taking my current medications?
The trial requires that you stop using any prescription medications 28 days before the study drug is given, unless the investigator approves them. Non-prescription medications, including vitamins and herbal products, should be stopped 14 days before the study drug, unless approved by the investigator.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that DZD8586 is well-tolerated by patients with certain blood cancers. Studies found that the drug's safety profile was acceptable, with most side effects being manageable or not severe. While this is reassuring, it's important to note that these results come from individuals who were already sick, not healthy adults like those in the current study. Since researchers are testing DZD8586 in healthy individuals for the first time, they will closely monitor any side effects. This monitoring helps ensure the drug's safety for everyone.12345
Why do researchers think this study treatment might be promising?
DZD8586 is unique because it represents a novel approach by potentially introducing a new active ingredient aimed at enhancing treatment outcomes. Unlike standard care options that typically revolve around well-established medications, DZD8586 could offer a fresh mechanism of action that targets the condition differently. Researchers are excited about this treatment due to its potential for improved safety and tolerability, which are critical for patient comfort and long-term management of the condition.
What evidence suggests that DZD8586 could be effective?
Research has shown that DZD8586, which participants in this trial may receive, may help treat chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). In studies, 15 out of 30 patients responded to the treatment, resulting in a 50% response rate. At a daily dose of 50 mg, it proved particularly effective, with 84.2% of patients showing improvement. Another study found a 57.9% response rate in patients taking 50 mg or more. These findings suggest that DZD8586 could help shrink tumors in certain blood cancers. Participants in this trial will receive either a single dose of DZD8586 or a placebo.12467
Who Is on the Research Team?
Frank Lee
Principal Investigator
Frontage Clinical Services, Inc.
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of DZD8586 or placebo to assess safety, tolerability, and pharmacokinetics
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- DZD8586
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dizal (Jiangsu) Pharmaceutical Co., Ltd.
Lead Sponsor