A Study of [14C]IBI351 in Healthy Subjects

Healthy Subjects Clinical Trial

Official title:

A Mass Balance Study of [14C]IBI351 in Healthy Male Chinese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05626179
• Other study ID #: CIBI351P002
• Status: Completed
• Phase: Phase 1
• Start date: February 18, 2023
• Est. completion date: May 18, 2023

Study information

• Verified date: December 2023
• Source: Innovent Biologics (Suzhou) Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: May 18, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

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

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Innovent Biologics (Suzhou) Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cumulative recovery of total radioactivity in excreta (urine and feces)		approximately 30 days after first dose
Primary	percentage of metabolite in total exposure AUC in plasma (% AUC)		approximately 30 days after first dose
Primary	percentage of each metabolite in urine to administered dose (% of administered dose)		approximately 30 days after first dose
Primary	Percentage of each metabolite in feces to administered dose (% of administered dose)		approximately 30 days after first dose
Primary	total radioactivity ratio for whole blood/plasma		approximately 30 days after first dose
Primary	maximum concentrations (Cmax ) for total plasma radioactivity		approximately 30 days after first dose
Primary	time-to-maximum concentration (Tmax) for total plasma radioactivity		approximately 30 days after first dose
Primary	half-life (t1/2) for total plasma radioactivity		approximately 30 days after first dose
Primary	area under the curve from time 0 to the last time point (AUC0-t) for total plasma radioactivityarea under the curve from time 0 to the last time point (AUC0-t) for total plasma radioactivity		approximately 30 days after first dose
Primary	area under the curve from time 0 to infinity(AUC0-inf) for total plasma radioactivity		approximately 30 days after first dose
Primary	apparent clearance (CL/F) for total plasma radioactivity		approximately 30 days after first dose
Primary	apparent volume of distribution(Vz/F) for total plasma radioactivity		approximately 30 days after first dose
Secondary	maximum concentrations (Cmax ) for plasma		approximately 30 days after first dose
Secondary	time-to-maximum concentration (Tmax) for plasma		approximately 30 days after first dose
Secondary	area under the curve from time 0 to the last time point (AUC0-t) for plasma		approximately 30 days after first dose
Secondary	area under the curve from time 0 to infinity(AUC0-inf) for plasma		approximately 30 days after first dose
Secondary	apparent clearance (CL/F) for plasma		approximately 30 days after first dose
Secondary	apparent volume of distribution(Vz/F) for plasma		approximately 30 days after first dose
Secondary	adverse events		approximately 30 days after first dose
Secondary	abnormality in vital signs		approximately 30 days after first dose
Secondary	abnormality in ECG parameters		approximately 30 days after first dose
Secondary	abnormality in physical examination		approximately 30 days after first dose
Secondary	abnormality in hematology parameters		approximately 30 days after first dose
Secondary	abnormality in clinical chemistry parameters		approximately 30 days after first dose
Secondary	abnormality in routine urinalysis parameters		approximately 30 days after first dose
Secondary	abnormality in routine stool parameters		approximately 30 days after first dose
Secondary	abnormality in coagulation parameters		approximately 30 days after first dose
Secondary	abnormality in Troponin T (TnT)		approximately 30 days after first dose