A Study of AL8326 in Healthy Subjects

NCT07132957 | Completed Phase 1

• 1 other identifier: AL8326-CN-011
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This experiment plans to enroll 6-8 healthy male subjects in China, and ultimately collect complete test samples and data from at least 6 subjects as the standard. On the first day of the experiment, each subject orally took a single dose of \[14C\] AL8326 oral formulation containing approximately 60mg (200 μ Ci). During the experiment, whole blood, plasma, urine, and fecal samples were collected at designated time points/time periods.

Conditions

Small Cell Lung Cancer; Solid Tumors

Outcome Measures

Primary Outcomes (5)

• Material balance

  the cumulative excretion rate of total radioactive material in excreta (urine and feces);

  All excreted urine and feces samples at specified time points during 0-480 hours after dosing will be collected.

• Metabolites

  The percentage of the original drug and each metabolite in urine and feces (% dose)

  Conduct testing within 1 month after all subjects collect plasma, urine, and fecal samplesat all time points required by the protocol

• Metabolites

  The AUC percentage of the original drug and circulating metabolites in plasma (%AUC) were calculated;

  Conduct testing within 1 month after all subjects collect plasma samplesat all time points required by the protocol

• Pharmacokinetic

  Pharmacokinetic parameters for total radioactivity in plasma， including peak concentration (Cmax), time to peak (Tmax), area under the drug-time curve (AUC0-t and AUC0-∞), elimination half-life (t1/2), apparent clearance (CL/F), apparent volume of distribution (Vd/F) and mean residence time (MRT). ) and mean residence time (MRT).

  Conduct testing within 1 month after all subjects collect plasma samplesat all time points required by the protocol

• whole blood

  whole blood to plasma total radioactivity partition ratio

  Conduct testing within 1 month after all subjects collect plasma samplesat all time points required by the protocol

Secondary Outcomes (2)

• Plasma pharmacokinetics

  Conduct testing within 1 month after all subjects collect plasma, urine, and fecal samplesat all time points required by the protocol

• Safety

  From signing the ICF until 22 days after the first dosing

Study Arms (1)

14C-labeled AL8326

EXPERIMENTAL

Single dose

Drug: 14C-labeled AL8326

Interventions

14C-labeled AL8326 DRUG

Oral, About 60mg (200μCi) of 14C-labeled AL8326

14C-labeled AL8326

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, 18 to 45 years of age (inclusive)
• Body mass index (BMI) of 19-26 kg/m2 (inclusive), and body weight not less than 50 kg (inclusive)
• Subjects who had no fertility or sperm donation plan from signing the informed consent until 1 year after the end of the trial, or those who agreed that the subjects and their partners should strictly use contraception from signing the informed consent until 1 year after the end of the trial; Voluntarily signing the ICF，Ability to communicate well with the investigator and compliance to complete the trial according to the protocol.

You may not qualify if:

• Subjects presenting with any of the following will not be included in the study:
• Clinically significant abnormality of physical examination, vital signs, routine laboratory tests (hematology, blood chemistry, coagulation, urinalysis, and stool routine + occult blood), 12-lead ECG, chest X-ray (anterograde), digital anal examination, thyroid function,ophthalmic examination and abdomen ultrasound (liver, gallbladder, pancreas, spleen, and kidneys), etc.
• Subjects with an allergic constitution, such as known allergic history to two or more substances, or allergic diseases, or those who may be hypersensitive to the investigational drug or its excipients, as judged by the investigator;
• Gastrointestinal diseases causing clinically significant symptoms such as nausea, vomiting, diarrhea, or malabsorption syndrome; Or a history of severe vomiting or diarrhea within one week before the screening period;
• History of dysphagia or any condition that may affect drug absorption (e.g., gastrectomy, cholecystectomy, gastric bypass, duodenotomy, colectomy);
• History of any clinical critical illness or presence of diseases or conditions that the investigator considers may affect the trial results, including but not limited to diseases of digestive system, circulatory system, respiratory system, endocrine system, nervous system, urinary system or blood, immune system, psychiatric system and metabolism and nutrition diseases ;
• History of organic heart disease, heart failure, myocardial infarction, angina pectoris, torssion ventricular tachycardia, ventricular tachycardia, long QT syndrome or family history (genetic proof or sudden death of a close relative at a young age);
• Major surgery within 6 months before screening or incomplete healing of surgical incision, the major surgeries including but not limited to any procedures that have significant risk of hemorrhage, prolonged general anesthesia, open biopsy, or marked traumatic invasive injury;
• History of active bleeding (e.g., peptic ulcer, intracranial hemorrhage, skin ecchymosis, gingival bleeding); History of any disease within the previous 6 months that may increase the risk of bleeding (such as tumor bleeding, spontaneous hematoma, eye bleeding, hemoptysis, gastrointestinal bleeding or ulcers,hematuria,reproductive system bleeding, traumatic hematoma/bleeding, and frequent epistaxis/gingival bleeding/subcutaneous or skin bleeding) were screened.
• Hemorrhoids or perianal diseases with regular/current hematochezia;
• Hepatitis B surface antigen , hepatitis C virus antibody IgG test, human immunodeficiency virus antigen/antibody combination test, or Treponema pallidum antibody test is positive
• 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;
• Participation in any other clinical trial (including drug and device clinical trials) within 3 months before screening;
• Habitual constipation or diarrhea;

Sponsors & Collaborators

• Advenchen Laboratories Nanjing Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• LiYan Miao

  The First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: August 20, 2025
• Study Start: February 21, 2025
• Primary Completion: May 17, 2025
• Study Completion: May 17, 2025
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)