Lymphoma, Non-HodgkinPhase 1NCT05176873
A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics of DZD8586 in Healthy Adult Participants
A Phase 1 study testing DZD8586 in people with Lymphoma, Non-Hodgkin, run by Dizal (Jiangsu) Pharmaceutical Co., Ltd. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Lymphoma, Non-Hodgkin
- What is being tested?
- DZD8586
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2021to 22 May 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
- Normal AST, ALT, total bilirubin and serum alkaline phosphatase
Show all 14Show fewer
- Normal white blood cell (WBC), hemoglobin and platelet count
- Normal coagulation function
- CrCl ≥ 90 mL/min or eGFR > 80 mL/min/1.73m^2
- QT/QTc interval < 450 ms
- 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.
Who cannot join
- Any condition which in the opinion of the investigator would interfere with the participant's ability to provide informed consent, comply with study instructions, confound interpretation of study results, or endanger the participant if he or she takes part in the trial.
- Any of the following condition: positive Hepatitis B surface antigen (HBsAg), positive HCV antibodies, confirmed positive HIV test result, TB test or COVID-19 test.
- History of malignancy of any type, except the following: surgically excised non-melanomatous skin cancers more than 5 years before receiving the study drug.
- Has donated blood (including blood products) or experienced loss of blood ≥ 500 mL within 2 months before screening.
- Reported history or any clinically significant abnormalities at the screening of cardiac, hepatic, renal, respiratory, GI, endocrine, immunological, dermatological, hematological, neurological, or psychiatrical disease.
- Resting blood pressure > 140/90 mmHg at screening (a single repeat measurement is allowed if the initial measurement is outside of these limits). Resting pulse rate < 45 beats per minute.
Show all 19Show fewer
- Ingestion of grapefruit, grapefruit juice, pomegranate juice, star fruit, or orange marmalade (made with Seville oranges) within 1 week before screening.
- Participation in another clinical study with an investigational product administered in the last 28 days.
- Have previously completed or withdrawn from this study or any other study investigating DZD8586 and have previously received DZD8586.
- Involvement in the planning and/or conduct of the study (applies to both Dizal staff and/or staff at the study site).
- Previous enrolment or randomization in the present study.
- For women only - currently pregnant (confirmed with positive pregnancy test) or breast-feeding.
- Testing positive for alcohol and/or drugs of abuse at screening and check-in.
- Self-reported substance abuse (e.g., alcohol, licit or illicit drugs) within 12 months of screening.
- Unwilling or unable to limit the substance such as alcohol consumption as defined in the restriction section throughout the course of the study.
- Received a live or live-attenuated vaccine within 3 months before the first dose of the study drug, except COVID-19 vaccine (within 2 weeks).
- Use or intend to use any prescription within 28 days prior to study drug administration, unless deemed acceptable by the investigator (or designee). Concomitant prescription drugs should also be restricted during administration of study drug. Exceptions may be allowed on a case-by-case basis as agreed by the investigator and sponsor's medical monitor if considered not to interfere with the aims of the study.
- Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant derived preparations, gastric pH modifiers, and neutralizing antacids within 14 days prior to study drug administration, unless deemed acceptable by the investigator (or designee). Concomitant non-prescription drugs should also be restricted during administration of study drug.
- Use or intend to use slow-release medications/products considered to still be active within 14 days prior to check-in, unless deemed acceptable by the investigator (or designee).
Trial locations and contacts
1 site in 1 country.
United States1 site
Frontage Clinical Service 200 Meadowlands Parkway
Secaucus, New Jersey, 07094
About this study
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.
Read the detailed description
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.
- Conditions
- Lymphoma, Non-Hodgkin
- Being tested
- DZD8586, Placebo
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DZD8586Drug
Single dose of DZD8586. Starting dose of DZD8586 is 20mg. If tolerated, subsequent cohorts will test increasing doses of DZD8586.
PlaceboDrug
A single oral dose of placebo will be given.
| Study group | Role | What they receive |
|---|---|---|
| Single dose of DZD8586 | Experimental | Single dose of DZD8586 Receives: Drug: DZD8586 |
| Single dose of Placebo | Placebo comparator | Single dose of Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and percentage of participants with adverse event, serious adverse event, clinically defined abnormal vital signs, laboratory values, ECG abnormalities
Measured: 6 days after the last dose
Secondary outcomes (1)
Plasma and urine concentrations of DZD8586
Measured: 6 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start9 Dec 2021
- Primary completion11 May 2022
- Study completion22 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Non-HodgkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dizal (Jiangsu) Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frank Lee, Principal investigator, Frontage Clinical Services, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05176873
- Sponsor's protocol ID
- DZ2021B0002
- Status last verified
- Jul 2022
- First submitted
- 15 Dec 2021
- Last updated
- 7 Sep 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics of DZD8586 in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT05176873
- Acronym / sponsor ID
- DZ2021B0002
- Conditions
- Lymphoma, Non-Hodgkin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Dizal (Jiangsu) Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Dec 2021 (actual)
- Primary completion
- 11 May 2022 (actual)
- Study completion
- 22 May 2022 (actual)
- First posted
- 4 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single dose of DZD8586 | Experimental | Drug: DZD8586Single dose of DZD8586 |
| Single dose of Placebo | Placebo comparator | Drug: PlaceboSingle dose of Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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:
Key exclusion criteria (19 listed)
- Any condition which in the opinion of the investigator would interfere with the participant's ability to provide informed consent, comply with study instructions, confound interpretation of study results, or endanger the participant if he or she takes part in the trial.
- Any of the following condition: positive Hepatitis B surface antigen (HBsAg), positive HCV antibodies, confirmed positive HIV test result, TB test or COVID-19 test.
- History of malignancy of any type, except the following: surgically excised non-melanomatous skin cancers more than 5 years before receiving the study drug.
- Has donated blood (including blood products) or experienced loss of blood ≥ 500 mL within 2 months before screening.
- Reported history or any clinically significant abnormalities at the screening of cardiac, hepatic, renal, respiratory, GI, endocrine, immunological, dermatological, hematological, neurological, or psychiatrical disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DZD8586Single dose of DZD8586. Starting dose of DZD8586 is 20mg. If tolerated, subsequent cohorts will test increasing doses of DZD8586. | Drug | Single dose of DZD8586 |
| PlaceboA single oral dose of placebo will be given. | Drug | Single dose of Placebo |
Primary outcome
Number and percentage of participants with adverse event, serious adverse event, clinically defined abnormal vital signs, laboratory values, ECG abnormalities
Time frame: 6 days after the last dose
1 secondary outcome
Plasma and urine concentrations of DZD8586
Time frame: 6 days after the last dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Lymphoma, Non-Hodgkin
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Active, not recruitingObservational study
Multi-omics Profiling of Relapsed Extranodal Natural Killer (NK)/T-cell Lymphoma
Extranodal NK/T-cell Lymphoma, Nasal Type
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Lee principal investigator
Frontage Clinical Services, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DZD8586 in people with Lymphoma, Non-Hodgkin, run by Dizal (Jiangsu) Pharmaceutical Co., Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and percentage of participants with adverse event, serious adverse event, clinically defined abnormal vital signs, laboratory values, ECG abnormalities (time frame: 6 days after the last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2023.