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

NCT05841940 | Completed Phase 1

• 1 other identifier: HLX208-PK-002
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Mass Balance Study in Healthy Subjects

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (6)

• HLX208 and metabolite PK: Cmax

  Up to 240 hours post dose.

• HLX208 and metabolite PK: Tmax

  Up to 240 hours post dose.

• HLX208 and metabolite PK: AUC0-t

  Up to 240 hours post dose.

• HLX208 and metabolite PK: AUC0-∞

  Up to 240 hours post dose.

• HLX208 and metabolite PK: t1/2

  Up to 240 hours post dose.

Study Arms (1)

[14C]HLX208

EXPERIMENTAL

Single oral dose of 450mg \[14C\]HLX208 suspension.

Drug: [14C]HLX208

Interventions

[14C]HLX208 DRUG

Carbon-14 labeled HLX208

[14C]HLX208

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Henlius Biotech: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Location

Study Officials

• Liyan Miao, Dr.

  The First Affiliated Hospital of Soochow University

  PRINCIPAL INVESTIGATOR

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: April 24, 2023
• First Posted: May 3, 2023
• Study Start: June 17, 2023
• Primary Completion: July 15, 2023
• Study Completion: December 15, 2023
• Last Updated: January 16, 2024

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)