Lymphoma, Non-HodgkinPhase 1NCT07454863
A Mass Balance Study of DZD8586 in Healthy Male Participants (TAI-SHAN15)
A Phase 1 study testing DZD8586 in people with Lymphoma, Non-Hodgkin, run by Dizal Pharmaceuticals at 1 site in China.
Trial summary
This phase I study is designed to evaluate absorption, metabolism and excretion (AME) profiles of [14C]-DZD8586, to determine the routes, rates of elimination, and mass balance of DZD8586 in healthy adult male participants. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy 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?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 16 Mar 2026to 6 Apr 2026
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Each participant must meet all criteria below to be included in this study:
- Provision of signed and dated, written informed consent prior to any study-specific procedures.
- Healthy male volunteers aged 18 to 45 years (inclusive) with a body mass index (BMI) between 19 and 26 kg/m2(inclusive) and body weight > 50 kg.
- The results of physical examination, laboratory tests, chest X-ray (posteroanterior view), electrocardiogram, and/or other auxiliary examinations (including abdominal ultrasound of the liver, gallbladder, pancreas, spleen, and kidneys; ophthalmologic examination; and digital rectal examination) are within normal results during the screening period or abnormal results with no clinical significance judged by the investigator.
- Male volunteers must be willing to use reliable methods of contraception (condom) even if their partners are postmenopausal, surgically sterile, or using an effective hormonal method of contraception or intrauterine coil. In addition, volunteers must agree to continue to take similar contraceptive precautions through 12 months after the administration of DZD8586, and avoid procreative sex as well as sperm donation during this period.
- Be willing and able to comply with the study procedures, restrictions, and requirements.
Who cannot join
- Each participant who meets any of the criteria below will be excluded from this study:
- Abnormalities in vital signs assessment (including pulse, blood pressure, and tympanic temperature) that persist upon repeat measurement.
- History or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
- For gastrointestinal function, the patient who meets the criteria below should be excluded:
- History or clinical manifestation of gastritis, gastrointestinal tract disorder, metabolic disorder, hepatic disorder, or other clinical condition
- Nausea, vomiting, diarrhea, or malabsorption syndrome, or those with a history of severe vomiting or diarrhea within one week before the screening period.
Show all 28Show fewer
- Abnormal bowel movements (ie, on average production of less than 1 stool per day) or other gastrointestinal disorder that might affect the intake and absorption of the drug, as judged by the investigator.
- Symptomatic hemorrhoids or perianal disease with regular/active rectal bleeding, irritable bowel syndrome, or inflammatory bowel disease during the screening period.
- History of other risk factors for TdP (such as heart failure, hypokalemia, and family history of long QT syndrome).
- During the screening period, the average resting corrected QTcF interval (QTC) on the ECG is > 450 msec.
- Major surgery or severe trauma within 4 weeks before the screening, or scheduled surgery during the study period.
- History of hemorrhagic disease (including hemophilia, von Willey-Brandland disease, etc), stroke, or intracranial hemorrhage within 6 months prior to the screening.
- Blood donation (including blood products) or blood loss ≥ 500 mL within 2 months prior to the screening, or receiving blood products within 4 weeks prior to the screening.
- Participants with any malignancy or neoplastic disease history, except those who have undergone excisional surgery of non-melanoma skin cancer over 5 years prior to the screening.
- History of latent or active tuberculosis, or positive screening result.
- Bacterial infection (including) within 30 days prior to the screening is considered inappropriate for participation by the investigator.
- Any infection on screening tests for Treponema pallidum, Hepatitis B Virus (HBsAg and HBcAb), Hepatitis C Virus (HCV), or human immunodeficiency virus (HIV-Ag/Ab).
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, or those who are known or suspected to be allergic to the investigational product or any of its excipients, as judged by the investigator.
- Has smoked an average of more than 5 cigarettes per day within the 3 months prior to screening, is a habitual user of nicotine-containing products, is unable to abstain from smoking/nicotine use during the trial period, or has a positive urine cotinine test.
- Has a known or suspected history of significant drug abuse (including licit or illicit drugs, alcohol, etc.) within 12 months prior to screening as judged by the investigator, a positive alcohol breath test result (>0 mg/100 mL) at screening, or a positive urine drug abuse screening test.
- Use of any prescribed medication within 4 weeks prior to the screening and refuse to restrict the use of prescription drugs Use or intention to use any prescription or over-the-counter medications (including but not limited to moderate to strong CYP3A4/5P inhibitor or inducers [including herbal products such as St. John's wort], any ADH and ALDH inhibitor/inducers, proton pump inhibitors, antacids, H2 receptor antagonists, and drugs that prolong QT/QTc interval, herbal products, natural or herbal supplements) within 4 weeks prior to the screening and through the end of the study, unless deems acceptable by the Investigator (or designee) and Sponsor.
- Participants who received live or live-attenuated vaccine in the 4 weeks prior to the screening (or related AEs haven't disappeared).
- Has participated in other clinical trials and received any investigational product or device within 3 months prior to the screening, plans to participate in another clinical trial during this study, or is not the actual personnel participating in the trial.
- Participants monitored for radiation exposure as part of their occupation.
- Radioactive exposure (≥2 times chest/abdominal CT scans, or ≥3 times other types of X-ray examinations) or those who have participated in radiopharmaceutical labelling tests within one year before the screening period.
- Participants who had been administered any amount of a [14C]-labelled compound within 12 months prior to the screening.
- History of vasovagal response to needles or blood, difficult venous access, or intolerance to venipuncture.
- Judgment by the investigator that the volunteer is not suitable to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Single-center, Non-randomized, Open-label, Mass Balance Study of Orally Administered [14C]-DZD8586 in Healthy Adult Male Participants
This phase I study is designed to evaluate absorption, metabolism and excretion (AME) profiles of [14C]-DZD8586, to determine the routes, rates of elimination, and mass balance of DZD8586 in healthy adult male participants. Participants will be administered a single oral dose of 50 mg of [14C]-DZD8586 (containing radioactive dose ~ 100 μCi) as a suspension.
- Conditions
- Lymphoma, Non-Hodgkin
- Being tested
- DZD8586
- 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
Carbon-14 labeled DZD8586
| Study group | Role | What they receive |
|---|---|---|
| Carbon-14 labeled DZD8586 | Experimental | Single oral administration of Carbon-14 labeled DZD8586 50 mg/100 μCi on empty stomach Receives: Drug: DZD8586 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total amount and recovery of the radioactive dose in urine and feces: Ae, Cum Ae, fe and Cum fe
Measured: All excreted urine and feces samples at specified time points during 0-504 hours after dosing will be collected
Metabolic profiling of relative abundance of [14C]-DZD8586 and metabolite identification of [14C]-DZD8586 in plasma, urine, and feces
Measured: Conduct testing within 1 month after all subjects collect plasma, urine, and fecal samples at all time points required by the protocol
Secondary outcomes (28)
Peak plasma concentration (Cmax) of DZD8586
Measured: up to 504 hours post dose
Peak plasma concentration (Cmax) of DZ4581
Measured: up to 504 hours post dose
Peak concentration (Cmax) of total radioactivity concentration equivalents in plasma and whole blood
Measured: Conduct testing within 1 month after all subjects collect whole blood and plasma samples at all time points defined by the protocol
Time to Cmax (Tmax) of DZD8586
Measured: up to 504 hours post dose
Time to Cmax (Tmax) of DZ4581
Measured: up to 504 hours post dose
Time to Cmax (Tmax) of total radioactivity concentration equivalents in plasma and whole blood
Measured: Conduct testing within 1 month after all subjects collect whole blood and plasma samples at all time points defined by the protocol
Elimination half-life (t1/2,λz) of DZD8586
Measured: up to 504 hours post dose
Elimination half-life (t1/2,λz) of DZ4581
Measured: up to 504 hours post dose
Elimination half-life (t1/2,λz) of total radioactivity concentration equivalents in plasma and whole blood
Measured: Conduct testing within 1 month after all subjects collect whole blood and plasma samples at all time points required by the protocol
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-t) of DZD8586
Measured: up to 504 hours post dose
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-t) of DZ4581
Measured: up to 504 hours post dose
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-t) of total radioactivity concentration equivalents in plasma and whole blood
Measured: Conduct testing within 1 month after all subjects collect whole blood and plasma samples at all time points required by the protocol
Area under the concentration-time curve from time zero to infinity (AUC0-inf) of DZD8586
Measured: up to 504 hours post dose
Area under the concentration-time curve from time zero to infinity (AUC0-inf) of DZ4581
Measured: up to 504 hours post dose
Area under the concentration-time curve from time zero to infinity (AUC0-inf) of total radioactivity concentration equivalents in plasma and whole blood
Measured: Conduct testing within 1 month after all subjects collect whole blood and plasma samples at all time points required by the protocol
Apparent oral clearance (CL/F) of DZD8586
Measured: up to 504 hours post dose
Apparent volume of distribution (Vz/F) of DZD8586
Measured: up to 504 hours post dose
PK parameters for renal clearance (CLR) for DZD8586 and DZ4581 in urine
Measured: up to 504 hours post dose
Amount and percentage of DZD8586 recovered in urine
Measured: up to 504 hours post dose
Plasma DZD8586-to-total plasma radioactivity ratio
Measured: Conduct testing within 1 month after all subjects collect plasma samples at all time points required by the protocol
Whole blood to plasma total radioactivity ratio
Measured: Conduct testing within 1 month after all subjects collect whole blood and plasma samples at all time points required by the protocol
Frequency, type and severity of adverse events/serious adverse events
Measured: Up to 3 weeks
Pulse rate
Measured: Up to 3 weeks
Blood pressure
Measured: Up to 3 weeks
Heart rate
Measured: Up to 3 weeks
RR, PR, QRS, and QT intervals
Measured: Up to 3 weeks
Number of participants with abnormal laboratory tests results (including blood chemistry, hematology, coagulation function, and urinalysis)
Measured: Up to 3 weeks
Number of participants with abnormal physical and ophthalmologic examinations findings
Measured: Up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start16 Mar 2026
- Primary completion27 Mar 2026
- Study completion6 Apr 2026
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.
- More trials run by Dizal PharmaceuticalsThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dizal Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yiqing Zhao, Principal investigator, Affiliated Hospital of Jiangnan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07454863
- Sponsor's protocol ID
- DZ2025B0003
- Status last verified
- May 2026
- First submitted
- 26 Jan 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- 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 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-center, Non-randomized, Open-label, Mass Balance Study of Orally Administered [14C]-DZD8586 in Healthy Adult Male Participants
- ClinicalTrials.gov ID
- NCT07454863
- Acronym / sponsor ID
- DZ2025B0003
- Conditions
- Lymphoma, Non-Hodgkin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Dizal PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 16 Mar 2026 (actual)
- Primary completion
- 27 Mar 2026 (actual)
- Study completion
- 6 Apr 2026 (actual)
- First posted
- 6 Mar 2026 (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 phase I study is designed to evaluate absorption, metabolism and excretion (AME) profiles of [14C]-DZD8586, to determine the routes, rates of elimination, and mass balance of DZD8586 in healthy adult male participants. Participants will be administered a single oral dose of 50 mg of [14C]-DZD8586 (containing radioactive dose ~ 100 μCi) as a suspension.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carbon-14 labeled DZD8586 | Experimental | Drug: DZD8586Single oral administration of Carbon-14 labeled DZD8586 50 mg/100 μCi on empty stomach |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Provision of signed and dated, written informed consent prior to any study-specific procedures.
- Healthy male volunteers aged 18 to 45 years (inclusive) with a body mass index (BMI) between 19 and 26 kg/m2(inclusive) and body weight > 50 kg.
- The results of physical examination, laboratory tests, chest X-ray (posteroanterior view), electrocardiogram, and/or other auxiliary examinations (including abdominal ultrasound of the liver, gallbladder, pancreas, spleen, and kidneys; ophthalmologic examination; and digital rectal examination) are within normal results during the screening period or abnormal results with no clinical significance judged by the investigator.
- Male volunteers must be willing to use reliable methods of contraception (condom) even if their partners are postmenopausal, surgically sterile, or using an effective hormonal method of contraception or intrauterine coil. In addition, volunteers must agree to continue to take similar contraceptive precautions through 12 months after the administration of DZD8586, and avoid procreative sex as well as sperm donation during this period.
- Be willing and able to comply with the study procedures, restrictions, and requirements.
Key exclusion criteria (28 listed)
- Abnormalities in vital signs assessment (including pulse, blood pressure, and tympanic temperature) that persist upon repeat measurement.
- History or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
- For gastrointestinal function, the patient who meets the criteria below should be excluded:
- History of other risk factors for TdP (such as heart failure, hypokalemia, and family history of long QT syndrome).
- During the screening period, the average resting corrected QTcF interval (QTC) on the ECG is > 450 msec.
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 |
|---|---|---|
| DZD8586Carbon-14 labeled DZD8586 | Drug | Carbon-14 labeled DZD8586 |
Primary outcome
Total amount and recovery of the radioactive dose in urine and feces: Ae, Cum Ae, fe and Cum fe
Time frame: All excreted urine and feces samples at specified time points during 0-504 hours after dosing will be collected
Metabolic profiling of relative abundance of [14C]-DZD8586 and metabolite identification of [14C]-DZD8586 in plasma, urine, and feces
Time frame: Conduct testing within 1 month after all subjects collect plasma, urine, and fecal samples at all time points required by the protocol
28 secondary outcomes
Peak plasma concentration (Cmax) of DZD8586
Time frame: up to 504 hours post dose
Peak plasma concentration (Cmax) of DZ4581
Time frame: up to 504 hours post dose
Peak concentration (Cmax) of total radioactivity concentration equivalents in plasma and whole blood
Time frame: Conduct testing within 1 month after all subjects collect whole blood and plasma samples at all time points defined by the protocol
Time to Cmax (Tmax) of DZD8586
Time frame: up to 504 hours post dose
Time to Cmax (Tmax) of DZ4581
Time frame: up to 504 hours post dose
Time to Cmax (Tmax) of total radioactivity concentration equivalents in plasma and whole blood
Time frame: Conduct testing within 1 month after all subjects collect whole blood and plasma samples at all time points defined by the protocol
Elimination half-life (t1/2,λz) of DZD8586
Time frame: up to 504 hours post dose
Elimination half-life (t1/2,λz) of DZ4581
Time frame: up to 504 hours post dose
Elimination half-life (t1/2,λz) of total radioactivity concentration equivalents in plasma and whole blood
Time frame: Conduct testing within 1 month after all subjects collect whole blood and plasma samples at all time points required by the protocol
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-t) of DZD8586
Time frame: up to 504 hours post dose
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-t) of DZ4581
Time frame: up to 504 hours post dose
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-t) of total radioactivity concentration equivalents in plasma and whole blood
Time frame: Conduct testing within 1 month after all subjects collect whole blood and plasma samples at all time points required by the protocol
Area under the concentration-time curve from time zero to infinity (AUC0-inf) of DZD8586
Time frame: up to 504 hours post dose
Area under the concentration-time curve from time zero to infinity (AUC0-inf) of DZ4581
Time frame: up to 504 hours post dose
Area under the concentration-time curve from time zero to infinity (AUC0-inf) of total radioactivity concentration equivalents in plasma and whole blood
Time frame: Conduct testing within 1 month after all subjects collect whole blood and plasma samples at all time points required by the protocol
Apparent oral clearance (CL/F) of DZD8586
Time frame: up to 504 hours post dose
Apparent volume of distribution (Vz/F) of DZD8586
Time frame: up to 504 hours post dose
PK parameters for renal clearance (CLR) for DZD8586 and DZ4581 in urine
Time frame: up to 504 hours post dose
Amount and percentage of DZD8586 recovered in urine
Time frame: up to 504 hours post dose
Plasma DZD8586-to-total plasma radioactivity ratio
Time frame: Conduct testing within 1 month after all subjects collect plasma samples at all time points required by the protocol
Whole blood to plasma total radioactivity ratio
Time frame: Conduct testing within 1 month after all subjects collect whole blood and plasma samples at all time points required by the protocol
Frequency, type and severity of adverse events/serious adverse events
Time frame: Up to 3 weeks
Pulse rate
Time frame: Up to 3 weeks
Blood pressure
Time frame: Up to 3 weeks
Heart rate
Time frame: Up to 3 weeks
RR, PR, QRS, and QT intervals
Time frame: Up to 3 weeks
Number of participants with abnormal laboratory tests results (including blood chemistry, hematology, coagulation function, and urinalysis)
Time frame: Up to 3 weeks
Number of participants with abnormal physical and ophthalmologic examinations findings
Time frame: Up to 3 weeks
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 14 May 2026.
- 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.
Yiqing Zhao principal investigator
Affiliated Hospital of Jiangnan University
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 Pharmaceuticals at 1 site in China.
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 6 inclusion and 28 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 14 May 2026. 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 China. 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. 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?
Total amount and recovery of the radioactive dose in urine and feces: Ae, Cum Ae, fe and Cum fe (time frame: All excreted urine and feces samples at specified time points during 0-504 hours after dosing will be collected). The study lists 2 primary outcomes in all. 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 14 May 2026.