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A Study of [14C]IBI351 in Healthy Subjects

NCT ID: NCT05626179

Last Updated: 2023-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-18

Study Completion Date

2023-05-18

Brief Summary

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This study is to evaluate the mass balance of single oral dose of \[14C\] IBI351 in healthy subjects. Six to eight healthy male subjects were planned to be enrolled. After passing the screening, subjects were admitted to hospital and received training on medication, urine and feces collection and other procedures to ensure that they could perform relevant operations according to the protocol and SOP requirements. On the evening before medication, the patient had standard meals, and fasted uniformly overnight. On D1, the suspension containing recommended dose of \[14C\] IBI351 was administered in the morning on an empty stomach. Subjects have standardized meal during the trial and blood, urine, and feces samples were collected and safety laboratory tests were performed as scheduled.

Detailed Description

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Conditions

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Healthy Subjects

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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[14C] IBI351

Recommended dose of \[14C\] IBI351

Group Type OTHER

[14C] IBI351

Intervention Type DRUG

The oral formulation of \[14C\] IBI351 was formulated as a suspension for subjects to take orally in drinking water under fasting conditions

Interventions

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[14C] IBI351

The oral formulation of \[14C\] IBI351 was formulated as a suspension for subjects to take orally in drinking water under fasting conditions

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Voluntarily sign the informed consent form before the trial, and fully understand the content, process and possible adverse reactions of the trial.
2. Healthy male subjects aged 18 to 45 years (including both ends) at the time of signing informed consent.
3. Body weight is not less than 50 kg, and body mass index (BMI) is in the range of 19 \~ 26 kg/m2 (including both ends).
4. Vital signs, physical examination, laboratory tests (including blood routine, urine routine, blood biochemistry, coagulation, etc.), chest radiography, 12-lead ECG and other results were unremarkable; or abnormal examination results but judged by the investigator as clinically insignificant.

Exclusion Criteria

1. allergic constitution; known hypersensitivity to any component of the test drug or its preparation.
2. have special requirements for diet and cannot abide by the unified diet; or lactose intolerance.
3. history of dysphagia or any gastrointestinal disease that affects drug absorption.
4. blood donation or massive blood loss (\> 200 mL) within 3 months before screening, or blood transfusion within 1 month.
5. Have taken an investigational product or participated in any clinical trial within 3 months before taking the study drug.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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CIBI351P002

Identifier Type: -

Identifier Source: org_study_id