HPP737 Substance Balance Study in Human

NCT06584058 | Not Yet Recruiting

• 1 other identifier: 2024-HPP737-I-006
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Main research purpose

1. 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. 2.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;
3. 3.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.
4. 4.Take Investigational product once
5. 5.Stay in the clinic about 7 days for checkups and tests
6. 6.Report their symptoms

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (11)

• Cmax (peak concentration)

  radiation pharmacokinetic parameter

  Up to 12 months

• Tmax (peak time)

  radiation pharmacokinetic parameter

  Up to 12 months

• AUC0-T (area under drug time curve)

  radiation pharmacokinetic parameter

  Up to 12 months

• AUC0-∞ (area under drug time curve)

  radiation pharmacokinetic parameter

  Up to 12 months

• t1/2 (elimination half-life)

  radiation pharmacokinetic parameter

  Up to 12 months

• CL/F (apparent clearance)

  radiation pharmacokinetic parameter

  Up to 12 months

• Vd/F (apparent volume of distribution)

  radiation pharmacokinetic parameter

  Up to 12 months

• MRT (mean residence time)

  radiation pharmacokinetic parameter

  Up to 12 months

• Cumulative drug excretion(Urine)

  Radioactive excretion corresponding to urine samples

  Up to 12 months

• Cumulative drug excretion(stool)

  Radioactive excretion corresponding to stool samples

  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.

  Up to 12 months

Study Arms (1)

All healthy subjects

EXPERIMENTAL

Drug: HPP737

Interventions

HPP737 DRUG

\[14C\]HPP737 oral preparation, 20mg（150μCi）, once

All healthy subjects

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• 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;

Sponsors & Collaborators

• Newsoara Biopharma Co., Ltd.: lead

Study Sites (1)

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jie Pan, Master

  Second Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jason Chen

CONTACT

13681963490; jason.chen@newsoara.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: September 4, 2024
• Study Start: August 30, 2024
• Primary Completion: July 30, 2025
• Study Completion: August 30, 2025
• Last Updated: September 4, 2024

Record last verified: 2024-09

Locations

CN (1)