Health TrialsbyHealthPanel

A Mass Balance Study of [14C]HRS-1780 in Healthy Adult Male Subjects

ConditionChronic Kidney Diseases
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-45
SponsorShandong Suncadia Medicine Co., Ltd.

About this trial

The study aims to evaluate the pharmacokinetics, mass balance recovery, metabolite profile and metabolite identification of \[14C\]HRS-1780 following an oral single dose in healthy adult male participants.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Before the trial, sign the informed consent form, fully understand the trial content, process and possible adverse reactions, and be willing to complete the research as required by the trial protocol.

Aged 18 to 45 years old (inclusive) who are in good health and have signed the informed consent form on that day.

Body weight of no less than 50 kg and a body mass index (BMI) within the range of 19.0 to 26.0 kg/m2 (inclusive).

Participants (including their partners) shall have no intention to have children or donate sperm within three months after signing the informed consent form and shall voluntarily adopt the contraceptive measures stipulated in the protocol.

Disqualifiers

Clinically significant abnormalities in vital signs (complete physical examination, laboratory tests, biochemistry, urinalysis, coagulation function, stool routine and occult blood, thyroid function), 12-lead electrocardiogram, digital rectal examination, chest X-rays, abdominal ultrasound.

Positive hepatitis B virus (HBsAg), hepatitis B core antibody (HbcAb), hepatitis C virus (HCV Ab), human immunodeficiency virus (HIV), or syphilis at screening.

Receipt of medical devices or another investigational drug (including placebo) within the previous 3 months or within the 5 half-lives (whichever is longer), and plan to participate in other clinical trials of drugs or medical devices during the trial period.

History of illicit or prescription drug abuse in the past five years or drug addiction within 3 months of screening, or positive urine drug screen at screening/baseline.

Trial design

Design model

Single group

Treatments tested in this trial

  • [14C]HRS-1780

    Drug

    \[14C\]HRS-1780, oral.

Treatment groups

6 Participants
are divided into 1 treatment group
Group A: [14C]HRS-1780 GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Total radioactivity ratio of whole blood/plasma.

Time frame
0 to anticipated 11 days.
2

Tmax

Time to reach maximum concentration (Tmax).

Time frame
0 to anticipated 11 days.
3

Cmax

Maximum concentration (Cmax).

Time frame
0 to anticipated 11 days.
4

AUClast

Area under the concentration time curve from time point 0 to the last quantifiable time point (AUClast).

Time frame
0 to anticipated 11 days.

Secondary outcomes

1

Safety and tolerability as measured by incidence of adverse events (AEs) and serious AEs.

Time frame
0 to anticipated 11 days.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shandong Suncadia Medicine Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: