Health TrialsbyHealthPanel

A Mass Balance Study Of 14C-RAY1225 Injection In Healthy Chinese Participants

ConditionBasic Science
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorGuangdong Raynovent Biotech Co., Ltd

About this trial

This is an open-label, single-center, single-dose study.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Participants who sign the informed consent form, fully understand the content, process, and possible adverse reactions of the study, and are able to complete the study as required by the study protocol;

Healthy adult males aged 18-55 years (inclusive, based on the time of signing the ICF);

Weight ≥ 50 kg, and body mass index (BMI) = weight (kg)/height2 (m 2) between 20.0-35.0 kg/m2 (inclusive);

Participants (including partners) who agree to voluntarily use effective contraception from screening until 6 months after the investigational drug administration and have no sperm donation plan. For specific contraceptive measures

Disqualifiers

Subjects with trauma, surgical scar, or skin lesions at the proposed administration site (abdomen) who are not suitable for subcutaneous injection as assessed by the investigator;

History of hypoglycemic episodes within 12 months prior to screening;

Major surgery or serious infection within 12 weeks prior to screening;

Acute disease from the signing of the ICF to the administration of the investigational drug;

Trial design

Design model

Single group

Treatments tested in this trial

  • 14C-RAY1225

    Drug

    subcutaneous injection

Treatment groups

8 Participants
are divided into 1 treatment group
Group A: RAY1225Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Total radioactivity recovery and cumulative recovery in urine and feces in each time period;

To quantitatively analyze the total radioactivity in the excretions of healthy participants after subcutaneous injection of 14C-RAY1225, and to obtain the primary radioactivity recovery data and primary excretion pathways in humans;

Time frame
DAY1~DAY60
2

Radioactivity of each metabolite in urine and feces as a percentage of the total administered dose and the circulating metabolites in plasma as a percentage of the total exposure AUC (%AUC);

Time frame
DAY1~DAY60

Secondary outcomes

1

Occurrence of adverse events/significant adverse events/serious adverse events

Time frame
DAY1~DAY60

Other outcomes

Sponsors and contacts

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

Guangdong Raynovent Biotech Co., Ltd

Lead sponsor

Source ClinicalTrials.gov

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