Study on Mass Balance of [14C]HSK39297 in Healthy Chinese Adult Male Subjects

NCT06852092 | Completed Phase 1

• 1 other identifier: HSK39297-102
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the absorption, metabolism and excretion in healthy Chinese male subjects after a single oral dose of \[14C\]HSK39297

Conditions

Paroxysmal Nocturnal Hemoglobinuria (PNH)

Outcome Measures

Primary Outcomes (3)

• Recovery of total radioactivity in urine and fecal samples

  Mass balance recovery of total radioactivity in urine and fecal samples

  Up to 312 hours post dose

• Total radioactivity in plasma PK

  PK parameters of total radioactivity in the plasma; Ratio of total radioactivity concentration in whole blood/plasma at different time points.

  Up to 312 hours post dose.

• Percentage of radioactivity and identification of metabolites in plasma, urine and fecal samples

  Percentage of prototype drugs and its metabolites in plasma, urine and fecal samples. Identification of the major metabolites

  Up to 312 hours post dose.

Secondary Outcomes (1)

• Number of participants with adverse events

  Up to 312 hours post dose.

Study Arms (1)

[14C]HSK39297

EXPERIMENTAL

Drug: Carbon-14 labeled HSK39297

Interventions

Carbon-14 labeled HSK39297 DRUG

Dose A

[14C]HSK39297

Eligibility Criteria

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

You may qualify if:

• Chinese healthy male subjects aged between 18 and 45 years old (inclusive, at the time of signing the informed consent form);
• Body weight ≥ 50 kg and body mass index (BMI) within the range of 19 - 26 kg/m² (inclusive);
• Capable of comprehending the procedures and methodologies of this study, disposed to strictly adhere to the related requirements of the protocol, and capable of signing the informed consent form.

You may not qualify if:

• Abnormal and clinically significant findings in physical examination, vital signs, laboratory tests (blood routine, biochemistry, coagulation function, urine routine, stool routine + fecal occult blood, thyroid function), ophthalmic examination (slit lamp, intraocular pressure, fundus photography), 12 - lead electrocardiogram \[QT interval corrected by Fridericia method (QTcF), 350 - 450 ms (inclusive) for men\], X - ray chest film (anterior - posterior and lateral views), abdominal B - ultrasound (liver, gallbladder, pancreas, spleen), urinary system B - ultrasound (kidneys, ureters, bladder, prostate), etc.
• Positive for hepatitis B surface antigen, hepatitis C virus IgG antibody, human immunodeficiency virus antibody and antigen p24, and Treponema pallidum antibody.
• Use of prescription drugs, over - the - counter drugs, or health care products, including Chinese patent medicine, within 14 days before the screening period or within 5 half - lives of the drug (whichever is longer).
• Participated in a clinical trial and received investigational drugs or devices within 3 months before screening.
• Use of any drugs that inhibit or induce the activity of liver drug - metabolizing enzymes or P - gp inhibitors within 30 days before screening.
• Dysphagia or any conditions that may affect drug absorption (e.g., gastrectomy, cholecystectomy, gastric bypass, duodenotomy, colectomy).
• Habitual constipation/diarrhea (feces collection required), history of malabsorption syndrome, or severe GI symptoms within 1 week before screening.
• History of serious diseases in cardiovascular, digestive, etc. systems or other diseases/physiological conditions interfering with trial results.
• History of organic heart disease, heart failure, myocardial infarction, angina pectoris, unexplained arrhythmia, torsades de pointes, ventricular tachycardia, atrioventricular block, QT prolongation syndrome, or having symptoms of QT prolongation syndrome and a family history (indicated by genetic evidence or sudden cardiac death of close relatives at a young age).
• History of capsular bacterial infection (e.g., Neisseria meningitidis, etc.) within 6 months before screening.
• History of tuberculosis infection or currently suffering from tuberculosis.
• Underwent major surgery within 6 months before screening or surgical incision not healed (excluding healed appendicitis and rectal prolapse surgeries).
• Severely allergic, allergic to trial drugs/excipients, two or more other drugs/foods, or having special diet requirements and unable to follow a unified diet.
• Having hemorrhoids or perianal diseases with regular/ongoing rectal bleeding, irritable bowel syndrome, or inflammatory bowel disease.
• Alcoholism or regular drinking (\> 14 alcohol units/week) within 6 months before screening, or positive alcohol breath test.

Sponsors & Collaborators

• Haisco Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Location

MeSH Terms

Conditions

Hemoglobinuria, Paroxysmal

Condition Hierarchy (Ancestors)

Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Myelodysplastic Syndromes; Bone Marrow Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: February 28, 2025
• Study Start: September 9, 2024
• Primary Completion: September 27, 2024
• Study Completion: December 10, 2024
• Last Updated: February 28, 2025

Record last verified: 2025-02

Locations

CN (1)