Mass Balance Study of [14C]HLX208 in China Healthy Subjects

Mass Balance Study of [14C]HLX208 in China Healthy Subjects.

Study Overview

• Status: Completed
• Conditions: Mass Balance Study in Healthy Subjects
• Intervention / Treatment: Drug: [14C]HLX208

Detailed Description

A phase I study to quantify the total mass balance in healthy subjects after a single dose of [14C]HLX208.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China
      • The First Affiliated Hospital of Soochow University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy male subjects between the ages of 18 and 45 years (inclusive).
2. Subjects weighing ≥ 50 kg and Body Mass Index of 18.0 to 32.0 kg/m2.
3. No sperm donation or fertility plan during the study and within 12 months after the end of the study.
4. Subjects who have voluntarily participated in the study and signed the informed consent form with good compliance.

Exclusion Criteria:

1. Known history of drug or food allergy.
2. Known medical history judged by the investigator as not suitable for the study.
3. Has laboratory or physical examination abnormalities during the screening period.
4. Has a positive test for, HBV，HCV，HIV，or syphilis.
5. Has drug abuse history or positive drug abuse test results.
6. Has diseases affecting the absorption, distribution, metabolism, and excretion of oral drugs.
7. Has any other conditions judged by the investigator as not suitable for the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [14C]HLX208; Single oral dose of 450mg [14C]HLX208 suspension.	Drug: [14C]HLX208; Carbon-14 labeled HLX208

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mass balance recovery of total radioactivity in urine and fecal samples.	Mass balance recovery of total radioactivity in urine and fecal samples.	Up to 336 hours post dose.
Total radioactivity in plasma PK: Cmax	Maximum plasma concentration	Up to 240 hours post dose.
Total radioactivity in plasma PK: Tmax	Time for Cmax	Up to 240 hours post dose.
Total radioactivity in plasma PK: AUC0-t	Area under the plasma concentration time profile from time 0 to time of the last quantifiable concentration.	Up to 240 hours post dose.
Total radioactivity in plasma PK: AUC0-∞	Area under the plasma concentration time profile from time 0 to infinity.	Up to 240 hours post dose.
Total rradioactivity in plasma PK: t1/2	Elimination half-life.	Up to 240 hours post dose.
Total radioactivity in plasma PK: CL/F	Drug clearance.	Up to 240 hours post dose.
Total radioactivity in plasma PK: Vz/F	Apparent volume of distribution following oral administration.	Up to 240 hours post dose.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HLX208 and metabolite PK: Cmax	Maximum plasma concentration	Up to 240 hours post dose.
HLX208 and metabolite PK: Tmax	Time for Cmax	Up to 240 hours post dose.
HLX208 and metabolite PK: AUC0-t	Area under the plasma concentration time profile from time 0 to time of the last quantifiable concentration.	Up to 240 hours post dose.
HLX208 and metabolite PK: AUC0-∞	Area under the plasma concentration time profile from time 0 to infinity.	Up to 240 hours post dose.
HLX208 and metabolite PK: t1/2	Elimination half-life.	Up to 240 hours post dose.
Adverse events	Number of adverse events, which are any untoward medical occurrence regardless of attribution to study drug in a participant who received study drug.	Screening up to Day 15

Collaborators and Investigators

• Sponsor: Shanghai Henlius Biotech
• Investigators: Principal Investigator: Liyan Miao, Dr., The First Affiliated Hospital of Soochow University

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2023
• Primary Completion (Actual): July 15, 2023
• Study Completion (Actual): December 15, 2023

Study Registration Dates

• First Submitted: April 24, 2023
• First Submitted That Met QC Criteria: April 24, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Actual): January 16, 2024
• Last Update Submitted That Met QC Criteria: January 12, 2024
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: HLX208-PK-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No