A Mass Balance Study of [14C]HRS-9057 for Injection in Healthy Participants

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-45
SponsorFujian Shengdi Pharmaceutical Co., Ltd.

About this trial

This study is a single-center, open-label, single-dose phase I clinical trial. The trial is divided into four periods: screening, baseline, treatment, and follow-up

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Informed consent was obtained voluntarily

Healthy males aged 18 ~ 45 years (inclusive)

Body weight ≥50 kg, BMI 19 ~ 28 kg/m2 (inclusive)

Adopt efficient contraceptive measures

Disqualifiers

Have a history of drug allergy, specific allergy, or allergic constitution

Any previous or current medical history that may affect the safety of the participant in the trial or the course of the study drug in vivo

Have a history of risk factors for torsade de pointes

During the screening period, serum potassium, sodium, ALT, or AST were beyond the normal range, or the calculated eGFR was less than 90 mL/min/1.73m2

Trial design

Design model

Single group

Treatments tested in this trial

  • [14C]HRS-9057

    Drug

    \[14C\]HRS-9057

Treatment groups

6 Participants
are divided into 1 treatment group
Group A: Dose Level:AExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Total radioactivity recovery and cumulative total radioactivity recovery in urine and feces during each collection period

Time frame
From Day 1 to Day 28
2

Percentage of HRS-9057 parent drug and its metabolites in plasma relative to the total radioactivity exposure in plasma (%AUC)

Time frame
From Day 1 to Day 8
3

The percentage of HRS-9057 parent drug and its metabolites in urine and feces relative to the administered dose (%Dose)

Time frame
From Day 1 to Day 28
4

Pharmacokinetic parameter of total radioactivity in whole blood and plasma, including: Tmax

Time frame
From Day 1 to Day 28

Secondary outcomes

1

Pharmacokinetic parameter of HRS-9057, and other major metabolites (if applicable) in plasma, including: Tmax

Time frame
From Day 1 to Day 28
2

Pharmacokinetic parameter of HRS-9057, and other major metabolites (if applicable) in plasma, including: Cmax

Time frame
From Day 1 to Day 28
3

Pharmacokinetic parameter of HRS-9057, and other major metabolites (if applicable) in plasma, including: t1/2

Time frame
From Day 1 to Day 28
4

Pharmacokinetic parameter of HRS-9057, and other major metabolites (if applicable) in plasma, including: MRT

Time frame
From Day 1 to Day 28

Other outcomes

Sponsors and contacts

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