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COMPLETEDPHASE1

A Study of AL8326 in Healthy Subjects

A Phase I Study to Evaluate the Mass Balance of 14C-labeled AL8326 in Healthy Subjects

NCT07132957•Advenchen Laboratories Nanjing Ltd.

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.

Detailed Description

This experiment adopts a single center, open label, non randomized, single dose trial design. By measuring the total radioactivity, calculate the ratio of total radioactivity in whole blood to plasma of \[14C\] AL8326, pharmacokinetic parameters, recovery rate, and excretion pathway data of total radioactivity in plasma. At the same time, by identifying the spectra of radioactive metabolites and the structures of major metabolites in plasma, urine, and feces, the main metabolic elimination pathways and characteristics of AL8326 in the human body were obtained, as well as the circulating metabolites that are close to or higher than 10% of the total radioactive exposure in plasma.

Eligibility

Age

18 - 45 years

Sex

MALE

Healthy Volunteers

Yes

Inclusion Criteria

•1. Chinese healthy male subjects, 18 to 45 years of age (inclusive)
•2. Body mass index (BMI) of 19-26 kg/m2 (inclusive), and body weight not less than 50 kg (inclusive)
•3. 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.

Exclusion Criteria

•Subjects presenting with any of the following will not be included in the study:
•1. 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.
•2. 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;
•3. 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;
•4. History of dysphagia or any condition that may affect drug absorption (e.g., gastrectomy, cholecystectomy, gastric bypass, duodenotomy, colectomy);
•5. 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 ;
•6. 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);
•7. 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;
•8. 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.
•9. Hemorrhoids or perianal diseases with regular/current hematochezia;
+15 more criteria

Locations (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Key Dates

Start Date

February 21, 2025

Primary Completion Date

May 17, 2025

Completion Date

May 17, 2025

Last Updated

August 20, 2025

Enrollment

ACTUAL participants

Conditions

Small Cell Lung CancerSolid Tumors

Interventions

14C-labeled AL8326

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of AL8326 in Healthy Subjects

Inclusion Criteria

Exclusion Criteria

Association Between Galectin-3 Levels and Outcomes in Patients With Renal Cell Carcinoma, Transitional Cell Carcinoma , Non Small Cell Lung Cancer, and Hepatocellular Carcinoma, Treated With PD-1/PDL-1 Inhibitors

Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)

A Clinical Study of Calderasib (MK-1084) and Other Treatments for Participants With Non-Small Cell Lung Cancer (MK-1084-007/KANDLELIT-007)

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing

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