A Clinical Trial of XZP-3287 for Material Balance

NCT ID: NCT05478109

Last Updated: 2022-07-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-02
• Study Completion Date: 2023-01-04

Brief Summary

A single-centre, open-label, mass balance and biotransformation study in healthy male subjects utilising a single oral dose of [14C] XZP-3287

Conditions

Healthy Male Subjects

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

[14C]XZP-3287

Eligible healthy male subjects received a single oral 360 mg (radioactivity of 50µCi) dose of \[14C\]XZP-3287

Group Type: EXPERIMENTAL

[14C]XZP-3287

Intervention Type: DRUG

360 mg suspension containing 50µCi of \[14C\] XZP-3287

Interventions

[14C]XZP-3287

360 mg suspension containing 50µCi of \[14C\] XZP-3287

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy adult males aged 18 to 45 years (inclusive).

2. Body weight ≥ 50 kg for males; body mass index (BMI) in the range 19-26 kg/m2 (inclusive).

3. No mental disorders, cardiovascular system, nervous system, respiratory system, digestive system, urinary system, endocrine system and metabolic abnormalities.

4. No clinically significant vital signs, physical examination, laboratory tests, ECG findings.

5. No plans to have children within the last 12 months, and willing to use effective contraception within 12 months after the end of dosing.

6. Subjects are able to communicate well with the investigators, and be able to complete the trial according to the process, and sign an Informed Consent Form.

Exclusion Criteria

1. Subjects with a history of drug allergy, or atopic allergic disease (Asthma, urticaria, eczema dermatitis), or a known history of allergy to the test drug or its adjuvant components.

2. History of clinically significant ECG abnormalities or family history of long QT syndrome.

3. History of any significantly diseases affect drug absorption, distribution, metabolism, and excretion.

4. Positive test for hepatitis B (surface antigens HBs), or C (antibody HCs), positive test for HIV, Treponema pallidum antibody positive.

5. Positive results from urine drug screen test.

6. Donate blood or lose blood 200 mL or more within 1 month prior to dosing.

7. Subjects who have used any medication, herbal medicine, nutritional supplements or health care products within 4 weeks prior to the first dose of study medication, or participated in other clinical studies or participated in a clinical study of test preparation within 3 months prior to the first dose of study medication.

8. History of needles or blood fainting, or have difficulty in blood collection, or cannot tolerate venipuncture for blood collection.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Xuanzhu Biopharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Gaobo Boren Hospital

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Cuilan Xiao

Role: CONTACT

xiaocuilan@xuanzhubio.com

+86-13699167610

Facility Contacts

Fang Hou

Role: primary

houf@gobroadhealthcare.com

+86-10-83605200 ext. 856

Other Identifiers

XZP-3287-1004

Identifier Type: -

Identifier Source: org_study_id