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

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

Treatments tested in this trial

  • [14C]HRS-9057

Treatment groups

6 Participants
are divided into 1 treatment group