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Completed

NCT Number: NCT05841940

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

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

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Key information

Conditions

Mass Balance Study in Healthy Subjects

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

[14C]HLX208

Drug

Carbon-14 labeled HLX208

Primary outcomes

  1. Mass balance recovery of total radioactivity in urine and fecal samples.

    Time frame: Up to 336 hours post dose.

    Mass balance recovery of total radioactivity in urine and fecal samples.

  2. Total radioactivity in plasma PK: Cmax

    Time frame: Up to 240 hours post dose.

    Maximum plasma concentration

  3. Total radioactivity in plasma PK: Tmax

    Time frame: Up to 240 hours post dose.

    Time for Cmax

  4. Total radioactivity in plasma PK: AUC0-t

    Time frame: Up to 240 hours post dose.

    Area under the plasma concentration time profile from time 0 to time of the last quantifiable concentration.

  5. Total radioactivity in plasma PK: AUC0-∞

    Time frame: Up to 240 hours post dose.

    Area under the plasma concentration time profile from time 0 to infinity.

  6. Total rradioactivity in plasma PK: t1/2

    Time frame: Up to 240 hours post dose.

    Elimination half-life.

  7. Total radioactivity in plasma PK: CL/F

    Time frame: Up to 240 hours post dose.

    Drug clearance.

  8. Total radioactivity in plasma PK: Vz/F

    Time frame: Up to 240 hours post dose.

    Apparent volume of distribution following oral administration.

Secondary outcomes

  1. HLX208 and metabolite PK: Cmax

    Time frame: Up to 240 hours post dose.

    Maximum plasma concentration

  2. HLX208 and metabolite PK: Tmax

    Time frame: Up to 240 hours post dose.

    Time for Cmax

  3. HLX208 and metabolite PK: AUC0-t

    Time frame: Up to 240 hours post dose.

    Area under the plasma concentration time profile from time 0 to time of the last quantifiable concentration.

  4. HLX208 and metabolite PK: AUC0-∞

    Time frame: Up to 240 hours post dose.

    Area under the plasma concentration time profile from time 0 to infinity.

  5. HLX208 and metabolite PK: t1/2

    Time frame: Up to 240 hours post dose.

    Elimination half-life.

  6. Adverse events

    Time frame: Screening up to Day 15

    Number of adverse events, which are any untoward medical occurrence regardless of attribution to study drug in a participant who received study drug.

Sponsors and collaborators

Lead sponsor

Shanghai Henlius Biotech

Industry

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 3, 2023
Registry last updated
Jan 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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