PsoriasisNCT06584058
HPP737 Substance Balance Study in Human
A study testing HPP737 in people with Psoriasis, run by Newsoara Biopharma Co., Ltd. at 1 site in China.
Trial summary
Main research purpose 1. Quantitative analysis of the total amount of radioactivity in excreta (urine and feces) of male healthy subjects after oral administration of [14C]HPP737, to obtain the cumulative excretion rate and main excretion routes of human radioactivity; 2. 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
- Psoriasis
- What is being tested?
- HPP737
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2024to 30 Aug 2025
- Phase
- Interventional
- 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
- Chinese healthy adult males, aged 18-45 years (including boundary values);
- The body weight of the subject is not less than 50kg, and the body mass index (BMI) is between 19.0 and 26.0kg/m2 (including the boundary value);
- The subject has no sperm donation plan during the trial period and within six months after the completion of the trial, and the subject and his or her partner have no birth plan during the trial period and within six months after the completion of the trial and voluntarily take strict contraceptive measures (see Appendix 4 for details);
- Fully understand the purpose and requirements of the trial, voluntarily participate in the clinical trial and sign the written informed consent, and be able to complete the whole process of the trial according to the requirements of the trial.
Who cannot join
- Those who have undergone comprehensive physical examination, vital signs, laboratory examination (blood routine, blood biochemistry, coagulation test, urine routine, infectious disease screening, thyroid function, stool routine + occult blood), chest X-ray (positive position), anal digital examination, abdominal B-ultrasound (liver, bile, pancreas, spleen and kidney), urinary system B-ultrasound, and heart color ultrasound with clinical significance;
- During the screening period, any ECG abnormalities determined by the investigators to be clinically significant, including but not limited to electrocardiograms with machine reading abnormalities: Fridericia's formula (QTcF=QT/ (RR^0.33)) corrected QT interval (QTcF) >450 msec, QRS>110 msec, frequent atrial or ventricular premature beats;
- Patients with abnormal color vision, retinitis pigmentosa, macular degeneration, nonarteriotic anterior ischemic optic neuropathy (NAION), or other fundus history deemed unsuitable by the investigators;
- Allergic constitution, such as people who are known to be allergic to two or more substances, or have allergic diseases, or have a history of allergy to PDE4 inhibitors or similar drugs or their excipients;
- Habitual constipation or diarrhea, a history of malabsorption syndrome, or a history of severe nausea, vomiting, diarrhea, and constipation within one week before the screening period;
- have difficulty swallowing or any condition that may affect drug absorption (e.g., gastrectomy, cholecystectomy, gastric bypass, duodenotomy, colectomy);
Show all 24Show fewer
- Have a history of clinically serious disease or any disease or condition that the investigator believes may affect the test results, including but not limited to a history of digestive, circulatory, respiratory, endocrine, nervous, urinary, or blood, immune, psychiatric, or metabolic diseases;
- Previous history of organic heart disease, heart failure, myocardial infarction, angina pectoris, torsional ventricular tachycardia, ventricular tachycardia, QT prolongation syndrome or family history (genetic proof or close relatives at a young age due to sudden cardiac death);
- Major surgery or surgical incision not fully healed within 6 months prior to screening; Major surgery includes, but is not limited to, any surgery where there is a significant risk of bleeding, extended period of general anesthesia, or open biopsy or significant traumatic injury;
- Previous active bleeding (such as peptic ulcer, intracranial hemorrhage, skin ecchymosis, gingival bleeding); History of any medical condition that may increase the risk of bleeding (e.g. tumor bleeding, spontaneous hematoma, eye bleeding, hemoptysis, gastrointestinal bleeding or ulcers, hematuria, reproductive system bleeding, traumatic hematoma/bleeding and recurrent epistaxis/gingival bleeding/subcutaneous or skin bleeding, etc.) within 6 months prior to screening;
- Hemorrhoids or perianal disease accompanied by regular/blood in the stool, or positive stool occult blood test during the screening period;
- Use of any drug that affects drug metabolism enzymes or transporters (P-gp and BCRP) in the 30 days prior to screening, as detailed in Appendix 5;
- Have taken any prescription drugs, over-the-counter drugs, Chinese herbs or food supplements (vitamins, calcium supplements) in the 14 days prior to screening and before dosing;
- Those who have taken any clinical trial drug or participated in any other clinical trial (including drug and device clinical trials) within 3 months prior to the screening period;
- Those who have lost blood or donated blood (≥400mL) within 3 months before screening, or received blood transfusion or blood components within 1 month, or plan to donate blood within 3 months after the end of this trial;
- Smokers who smoked more than 5 cigarettes per day or habitually used nicotine-containing products in the 3 months prior to the screening period, or were unable to stop using any tobacco products during the trial period;
- Regular alcohol consumption in the six months prior to screening, i.e. drinking more than 14 units of alcohol per week (1 unit =285mL of beer or 25mL of 40% alcohol spirits or 100mL of wine), or a positive alcohol breath test, or unable to abstain during the test period;
- Drug abuse or drug use history, or drug abuse screening positive;
- Habitual or excessive (more than 8 cups a day, 1 cup =250mL) consumption of grapefruit juice, tea, coffee and/or caffeinated beverages, and unable to abstain during the trial period;
- Those who have special requirements for diet and cannot comply with a unified diet;
- Workers who require long-term exposure to radiation, or who have had significant radiation exposure (≥2 chest/abdominal CT, or ≥3 other types of X-rays) in the year prior to administration, or who have participated in radiopharma labeling tests;
- Patients with a history of needle fainting and blood fainting, difficulty in blood collection or inability to tolerate venous puncture blood collection;
- Those who had been vaccinated within 1 month prior to screening or planned to be vaccinated during the trial period;
- Subjects whose compliance is considered poor by the investigator, or who have other factors unsuitable for participation in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215000
Jie Pan
About this study
Official title: [14C] A Single-center, Nonrandomized, Open, Single-dose Substance Balance Study of HPP737 in Healthy Subjects
Main research purpose
- Quantitative analysis of the total amount of radioactivity in excreta (urine and feces) of male healthy subjects after oral administration of [14C]HPP737, to obtain the cumulative excretion rate and main excretion routes of human radioactivity;
- To identify the main metabolites in the offspring of [14C]HPP737 in healthy male subjects, and to determine the main biotransformation pathway and main metabolite structure;
- To investigate the distribution of total radioactivity in whole blood and plasma and the pharmacokinetics of total plasma radioactivity in healthy male subjects after a single oral administration of [14C]HPP737.
Read more
Participants will:
- Take Investigational product once
- Stay in the clinic about 7 days for checkups and tests
- Report their symptoms
- Conditions
- Psoriasis
- Being tested
- HPP737
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPP737Drug
[14C]HPP737 oral preparation, 20mg（150μCi）, once
| Study group | Role | What they receive |
|---|---|---|
| All healthy subjects | Experimental | Not described Receives: Drug: HPP737 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax (peak concentration)
radiation pharmacokinetic parameter
Measured: Up to 12 months
Tmax (peak time)
radiation pharmacokinetic parameter
Measured: Up to 12 months
AUC0-T (area under drug time curve)
radiation pharmacokinetic parameter
Measured: Up to 12 months
AUC0-∞ (area under drug time curve)
radiation pharmacokinetic parameter
Measured: Up to 12 months
t1/2 (elimination half-life)
radiation pharmacokinetic parameter
Measured: Up to 12 months
CL/F (apparent clearance)
radiation pharmacokinetic parameter
Measured: Up to 12 months
Vd/F (apparent volume of distribution)
radiation pharmacokinetic parameter
Measured: Up to 12 months
MRT (mean residence time)
radiation pharmacokinetic parameter
Measured: Up to 12 months
Cumulative drug excretion(Urine)
Radioactive excretion corresponding to urine samples
Measured: Up to 12 months
Cumulative drug excretion(stool)
Radioactive excretion corresponding to stool samples
Measured: Up to 12 months
Major metabolite
The main metabolites in plasma, urine and fecal samples were identified by liquid chromatography-mass spectrometry (LC-MS), and radioisotope metabolites were analyzed to provide the main biotransformation pathway of HPP737 in human body.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start30 Aug 2024 (estimated)
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Newsoara Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jie Pan, Master, Principal investigator, Second Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06584058
- Sponsor's protocol ID
- 2024-HPP737-I-006
- Status last verified
- Sep 2024
- First submitted
- 5 Aug 2024
- Last updated
- 4 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [14C] A Single-center, Nonrandomized, Open, Single-dose Substance Balance Study of HPP737 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06584058
- Acronym / sponsor ID
- 2024-HPP737-I-006
- Conditions
- Psoriasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Newsoara Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Aug 2024 (estimated)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 4 Sep 2024 (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.
Main research purpose
- Quantitative analysis of the total amount of radioactivity in excreta (urine and feces) of male healthy subjects after oral administration of [14C]HPP737, to obtain the cumulative excretion rate and main excretion routes of human radioactivity;
- To identify the main metabolites in the offspring of [14C]HPP737 in healthy male subjects, and to determine the main biotransformation pathway and main metabolite structure;
- To investigate the distribution of total radioactivity in whole blood and plasma and the pharmacokinetics of total plasma radioactivity in healthy male subjects after a single oral administration of [14C]HPP737.
Participants will:
- Take Investigational product once
- Stay in the clinic about 7 days for checkups and tests
- Report their symptoms
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All healthy subjects | Experimental | Drug: HPP737 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Chinese healthy adult males, aged 18-45 years (including boundary values);
- The body weight of the subject is not less than 50kg, and the body mass index (BMI) is between 19.0 and 26.0kg/m2 (including the boundary value);
- The subject has no sperm donation plan during the trial period and within six months after the completion of the trial, and the subject and his or her partner have no birth plan during the trial period and within six months after the completion of the trial and voluntarily take strict contraceptive measures (see Appendix 4 for details);
- Fully understand the purpose and requirements of the trial, voluntarily participate in the clinical trial and sign the written informed consent, and be able to complete the whole process of the trial according to the requirements of the trial.
Key exclusion criteria (24 listed)
- Those who have undergone comprehensive physical examination, vital signs, laboratory examination (blood routine, blood biochemistry, coagulation test, urine routine, infectious disease screening, thyroid function, stool routine + occult blood), chest X-ray (positive position), anal digital examination, abdominal B-ultrasound (liver, bile, pancreas, spleen and kidney), urinary system B-ultrasound, and heart color ultrasound with clinical significance;
- During the screening period, any ECG abnormalities determined by the investigators to be clinically significant, including but not limited to electrocardiograms with machine reading abnormalities: Fridericia's formula (QTcF=QT/ (RR^0.33)) corrected QT interval (QTcF) >450 msec, QRS>110 msec, frequent atrial or ventricular premature beats;
- Patients with abnormal color vision, retinitis pigmentosa, macular degeneration, nonarteriotic anterior ischemic optic neuropathy (NAION), or other fundus history deemed unsuitable by the investigators;
- Allergic constitution, such as people who are known to be allergic to two or more substances, or have allergic diseases, or have a history of allergy to PDE4 inhibitors or similar drugs or their excipients;
- Habitual constipation or diarrhea, a history of malabsorption syndrome, or a history of severe nausea, vomiting, diarrhea, and constipation within one week before the screening period;
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 |
|---|---|---|
| HPP737[14C]HPP737 oral preparation, 20mg（150μCi）, once | Drug | All healthy subjects |
Primary outcome
Cmax (peak concentration)
Time frame: Up to 12 months
radiation pharmacokinetic parameter
Tmax (peak time)
Time frame: Up to 12 months
radiation pharmacokinetic parameter
AUC0-T (area under drug time curve)
Time frame: Up to 12 months
radiation pharmacokinetic parameter
AUC0-∞ (area under drug time curve)
Time frame: Up to 12 months
radiation pharmacokinetic parameter
t1/2 (elimination half-life)
Time frame: Up to 12 months
radiation pharmacokinetic parameter
CL/F (apparent clearance)
Time frame: Up to 12 months
radiation pharmacokinetic parameter
Vd/F (apparent volume of distribution)
Time frame: Up to 12 months
radiation pharmacokinetic parameter
MRT (mean residence time)
Time frame: Up to 12 months
radiation pharmacokinetic parameter
Cumulative drug excretion(Urine)
Time frame: Up to 12 months
Radioactive excretion corresponding to urine samples
Cumulative drug excretion(stool)
Time frame: Up to 12 months
Radioactive excretion corresponding to stool samples
Major metabolite
Time frame: Up to 12 months
The main metabolites in plasma, urine and fecal samples were identified by liquid chromatography-mass spectrometry (LC-MS), and radioisotope metabolites were analyzed to provide the main biotransformation pathway of HPP737 in human body.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Psoriasis
Active, not recruitingPhase 4
Residual Disease MEMory in PSOriasis Skin During EnstiLAR® and Narrow-band Ultraviolet B Therapy: The MEMPSOLAR Study
Psoriasis Vulgaris, Psoriasis
RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
RecruitingPhase 3
Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)
Plaque Psoriasis
Active, not recruitingObservational study
Efficacy and Flexibility of Tildrakizumab Treatment in Patients With Moderate-to-severe Plaque Psoriasis and High Disease Burden
Psoriasis, Moderate to Severe Psoriasis
RecruitingObservational study
PsoBest - The German Psoriasis Registry
Psoriasis, Psoriatic-arthritis
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.
Jie Pan, Master principal investigator
Second Affiliated Hospital of Soochow University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HPP737 in people with Psoriasis, run by Newsoara Biopharma 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 4 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 4 Sep 2024. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jason Chen (13681963490, jason.chen@newsoara.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (peak concentration) (time frame: Up to 12 months). The study lists 11 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 4 Sep 2024; AzTrials last refreshed its copy on 29 Oct 2026.