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This is a study in healthy adult participants. This is the first time this drug has ever been tested in human, and so it will help to understand what type of side effects may occur with this intervention. It will also measure the levels of drug in the body.
This is a study in healthy adult participants. This is the first time this drug has ever been tested in human, and so it will help to understand what type of side effects may occur with this intervention. It will also measure the levels of drug in the body.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single dose of DZD8586 | Experimental | Single dose of DZD8586 |
|
| Single dose of Placebo | Placebo Comparator | Single dose of Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DZD8586 | Drug | Single dose of DZD8586. Starting dose of DZD8586 is 20mg. If tolerated, subsequent cohorts will test increasing doses of DZD8586. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number and percentage of participants with adverse event, serious adverse event, clinically defined abnormal vital signs, laboratory values, ECG abnormalities | 6 days after the last dose |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma and urine concentrations of DZD8586 | 6 days after the last dose |
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Inclusion Criteria:
Participants must be able to understand the nature of the trial and provide a signed and dated, written informed consent form before any study-specific procedures, sampling, and analyses.
Female and/or male aged 18~55 years (inclusive), at the time of signing the informed consent.
Body mass index (BMI) 18~30 kg/m2. Bodyweight of ≥ 45 kg (Female) or ≥ 55 kg (Male).
Non-smoker (never smoked or > 1 year from the last occurrence of smoking).
Participants are healthy as determined by medical history, physical examination, laboratory parameters, vital signs and ECG, performed before the first administration of the study drug, including the following criteria:
Male participants must be surgically sterile or using an acceptable method of contraception (defined as barrier methods in conjunction with spermicides) during the study (from the time they sign consent) and for 6 months after the last dose of the study drug to prevent pregnancy with a partner. Abstinence is an acceptable form of contraception, provided that the subject agrees to use barrier methods in conjunction with spermicides if they do engage in sexual intercourse.
However, periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of contraception. Male participants should refrain from sperm donation throughout this period.
Female partners (of childbearing potential) of male participants must also use a highly effective method of contraception throughout this period.
Female participants must have negative pregnancy tests at screening and check-in AND: have been surgically sterile (with documentation of hysterectomy, bilateral oophorectomy, bilateral salpingectomy, bilateral tubal ligation/tubal occlusion) OR post-menopausal (no menstruation for a minimum of 12 months and confirmed by follicle-stimulating hormone (FSH) and serum estradiol at screening) OR, if of child-bearing potential, must be using an acceptable method of contraception such as an intrauterine device, implant or contraceptive injection, or two forms of the following (e.g. diaphragm, cervical cap, oral, patch or vaginal hormonal contraceptive, condom, spermicide, or sponge) for the last three months. All females must agree to continue to use their method of birth control for the duration of the study and a minimum of one complete menstrual cycle.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank Lee | Frontage Clinical Services, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Frontage Clinical Service 200 Meadowlands Parkway | Secaucus | New Jersey | 07094 | United States |
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| Placebo | Drug | A single oral dose of placebo will be given. |
|
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |