MBPhase 1NCT07809217
Mass Balance Study of [¹⁴C]Purinostat Mesylate for Injection in Healthy Participants
A Phase 1 study testing 19 mg /50 μCi of [¹⁴C] Purinostat Mesylate in people with MB, run by Chengdu Zenitar Biomedical Technology Co., Ltd at 1 site in China.
Trial summary
This trial adopts a single-center, open-label, non-randomized, single-dose study design. It is planned to enroll 6 healthy Chinese male participants, and the final standard is to collect complete samples and data to be tested from at least 6 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
- MB
- What is being tested?
- 19 mg /50 μCi of [¹⁴C] Purinostat Mesylate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 28 Sep 2026to 31 Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- All participants must:1.Chinese healthy adult male, aged 18-45 years old 2.Participants weighing no less than 50 kg and having a body mass index (BMI) between 19.0 and 26.0 kg/m^2 3.Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign a written informed consent form, and be able to complete the entire trial process according to the trial requirements.
Who cannot join
- Participants must not：1.Those with allergic predisposition, such as those with a known history of allergies to two or more substances, or those with allergic diseases, or those who are severely allergic to the investigational product (IP)s and its excipients or HDAC inhibitors; 2.Those with habitual constipation or diarrhea, a history of malabsorption syndrome, or a history of severe nausea, vomiting, diarrhea, or constipation within one week before the screening period; 3.Those who have taken any clinical trial drugs or participated in any other clinical trials within 3 months before screening; 4.Be alcohol dependent or drug abusers.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, china
Lu Zhoulin, +86 512-67972861, sdfyec@163.com
About this study
Official title: A Single-center, Non-randomized, Open-label, Single-dose Mass Balance Study of [¹⁴C]Purinostat Mesylate for Injection in Healthy Participants
This trial adopts a single-center, open-label, non-randomized, single-dose study design. It is planned to enroll 6 healthy Chinese male participants, and the final standard is to collect complete samples and data to be tested from at least 6 participants.
After each participant receives a single intravenous infusion of 19 mg (approximately 50 μCi) of [¹⁴C] Purinostat Mesylate for Injection on the first day of the trial, whole blood, plasma, urine and feces samples will be collected at specified time points/time periods during the trial. By measuring the total radioactivity, the whole blood-to-plasma ratio of total radioactivity, the pharmacokinetic parameters of total, recovery rate and excretion route data of the total radioactivity in whole blood (if applicable) and plasma.
- Conditions
- MB
- Being tested
- 19 mg /50 μCi of [¹⁴C] Purinostat Mesylate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
19 mg /50 μCi of [¹⁴C] Purinostat MesylateDrug
Participants received a single intravenous infusion of [14C]Purinostat Mesylate under fasting conditions. The dose was set at the clinically proposed standard dosage (approximately 19 mg per person, administered once, with a radioactive activity of 50 μCi).
| Study group | Role | What they receive |
|---|---|---|
| Purinostat Mesylate | Experimental | Not described Receives: Drug: 19 mg /50 μCi of [¹⁴C] Purinostat Mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative excretion rate of total radioactivity in urine and feces
Measured: Through 216 hours postdose
Secondary outcomes (4)
Cmax
Measured: Through 120 hours postdose
Tmax
Measured: Through 120 hours postdose
AUC0-t
Measured: Through 120 hours postdose
t1/2
Measured: Through 120 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start28 Sep 2026 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MBStudies of the same condition, open and under way.
- More trials run by Chengdu Zenitar Biomedical Technology Co., LtdThe 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 (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu Zenitar Biomedical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07809217
- Sponsor's protocol ID
- ZLPM-008-MB
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Non-randomized, Open-label, Single-dose Mass Balance Study of [¹⁴C]Purinostat Mesylate for Injection in Healthy Participants
- ClinicalTrials.gov ID
- NCT07809217
- Acronym / sponsor ID
- ZLPM-008-MB
- Conditions
- MB
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Chengdu Zenitar Biomedical Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2026 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 9 Sep 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 trial adopts a single-center, open-label, non-randomized, single-dose study design. It is planned to enroll 6 healthy Chinese male participants, and the final standard is to collect complete samples and data to be tested from at least 6 participants.
After each participant receives a single intravenous infusion of 19 mg (approximately 50 μCi) of [¹⁴C] Purinostat Mesylate for Injection on the first day of the trial, whole blood, plasma, urine and feces samples will be collected at specified time points/time periods during the trial. By measuring the total radioactivity, the whole blood-to-plasma ratio of total radioactivity, the pharmacokinetic parameters of total, recovery rate and excretion route data of the total radioactivity in whole blood (if applicable) and plasma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Purinostat Mesylate | Experimental | Drug: 19 mg /50 μCi of [¹⁴C] Purinostat Mesylate |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All participants must:1.Chinese healthy adult male, aged 18-45 years old 2.Participants weighing no less than 50 kg and having a body mass index (BMI) between 19.0 and 26.0 kg/m^2 3.Fully understand the purpose and requirements of this trial, voluntarily participate in the clinical trial and sign a written informed consent form, and be able to complete the entire trial process according to the trial requirements.
Key exclusion criteria (1 listed)
- Participants must not：1.Those with allergic predisposition, such as those with a known history of allergies to two or more substances, or those with allergic diseases, or those who are severely allergic to the investigational product (IP)s and its excipients or HDAC inhibitors; 2.Those with habitual constipation or diarrhea, a history of malabsorption syndrome, or a history of severe nausea, vomiting, diarrhea, or constipation within one week before the screening period; 3.Those who have taken any clinical trial drugs or participated in any other clinical trials within 3 months before screening; 4.Be alcohol dependent or drug abusers.
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 |
|---|---|---|
| 19 mg /50 μCi of [¹⁴C] Purinostat MesylateParticipants received a single intravenous infusion of [14C]Purinostat Mesylate under fasting conditions. The dose was set at the clinically proposed standard dosage (approximately 19 mg per person, administered once, with a radioactive activity of 50 μCi). | Drug | Purinostat Mesylate |
Primary outcome
Cumulative excretion rate of total radioactivity in urine and feces
Time frame: Through 216 hours postdose
4 secondary outcomes
Cmax
Time frame: Through 120 hours postdose
Tmax
Time frame: Through 120 hours postdose
AUC0-t
Time frame: Through 120 hours postdose
t1/2
Time frame: Through 120 hours postdose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
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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.
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 19 mg /50 μCi of [¹⁴C] Purinostat Mesylate in people with MB, run by Chengdu Zenitar Biomedical Technology Co., Ltd 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 9 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wang Fangmei (+8613808086495, fangmei.wang@zenitar.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative excretion rate of total radioactivity in urine and feces (time frame: Through 216 hours postdose). 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 9 Sep 2026.