A Clinical Trial of XZP-3287 for Material Balance

Xuanzhu Biopharmaceutical

Status and phase: Not yet enrolling; Phase 1

Conditions: Healthy Male Subjects

Treatments: Drug: [14C]XZP-3287

Study type: Interventional

Funder types: Industry

Identifiers

NCT05478109

XZP-3287-1004

Details and patient eligibility

About

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

Enrollment: 10 estimated patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

[14C]XZP-3287

Experimental group

Description:

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

Treatment:

Drug: [14C]XZP-3287