A Study of [14C]IBI351 in Healthy Subjects

NCT05626179 | Completed Phase 1

• 1 other identifier: CIBI351P002
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (12)

• cumulative recovery of total radioactivity in excreta (urine and feces)

  approximately 30 days after first dose

• percentage of metabolite in total exposure AUC in plasma (% AUC)

  approximately 30 days after first dose

• percentage of each metabolite in urine to administered dose (% of administered dose)

  approximately 30 days after first dose

• Percentage of each metabolite in feces to administered dose (% of administered dose)

  approximately 30 days after first dose

• total radioactivity ratio for whole blood/plasma

  approximately 30 days after first dose

• maximum concentrations (Cmax ) for total plasma radioactivity

  approximately 30 days after first dose

• time-to-maximum concentration (Tmax) for total plasma radioactivity

  approximately 30 days after first dose

• half-life (t1/2) for total plasma radioactivity

  approximately 30 days after first dose

• 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

• area under the curve from time 0 to infinity(AUC0-inf) for total plasma radioactivity

  approximately 30 days after first dose

• apparent clearance (CL/F) for total plasma radioactivity

  approximately 30 days after first dose

• apparent volume of distribution(Vz/F) for total plasma radioactivity

  approximately 30 days after first dose

Secondary Outcomes (16)

• maximum concentrations (Cmax ) for plasma

  approximately 30 days after first dose

• time-to-maximum concentration (Tmax) for plasma

  approximately 30 days after first dose

• area under the curve from time 0 to the last time point (AUC0-t) for plasma

  approximately 30 days after first dose

• area under the curve from time 0 to infinity(AUC0-inf) for plasma

  approximately 30 days after first dose

• apparent clearance (CL/F) for plasma

  approximately 30 days after first dose

Study Arms (1)

[14C] IBI351

OTHER

Recommended dose of \[14C\] IBI351

Drug: [14C] IBI351

Interventions

[14C] IBI351 DRUG

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

[14C] IBI351

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Voluntarily sign the informed consent form before the trial, and fully understand the content, process and possible adverse reactions of the trial.
• Healthy male subjects aged 18 to 45 years (including both ends) at the time of signing informed consent.
• 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).
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (1)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: November 23, 2022
• Study Start: February 18, 2023
• Primary Completion: March 30, 2023
• Study Completion: May 18, 2023
• Last Updated: December 27, 2023

Record last verified: 2023-12

Locations

CN (1)