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Evaluation of the Bioequivalence of RAY1225 Injection in Healthy 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 a single-center, randomized, open, parallel-designed bioequivalence study aimed at evaluating the pharmacokinetic differences of RAY1225 injection after site and batch changes compared to before the changes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signature of a dated Informed Consent Form (ICF) indicating that the subject has been informed of all the relevant aspects(including adverse events) of the trial prior to enrollment.

Participants must be willing and able to adhere to the visit schedule and protocol requirements and be available to complete the study.

Participants (including partners) must use reliable methods of contraception during the study and until 3 months following the last dose of investigational product.

Body weight is no less than 55 kg in males and no less than 50 kg in females. Body mass index (BMI) 22≤BMI<28 kg/m2.

Disqualifiers

A history of medullary thyroid carcinoma (MTC) or current diagnosis of MTC, or a family history of MTC (grandparents, parents, and siblings), or a diagnosis of multiple endocrine neoplasia type 2 (MEN2);

A history of hypoglycemic episodes within 12 months prior to screening;

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

Acute illness occurring from the time of signing the informed consent form to the administration of the investigational drug;

Trial design

Design model

Parallel

Treatments tested in this trial

  • RAY1225

    Drug

    Single subcutaneous injection of RAY1225 3mg

Treatment groups

68 Participants
are divided into 2 treatment groups
Group A: group AExperimental treatment 1 intervention
Group B: group BActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of RAY1225 From Time Zero to T (AUC[0-t])

Time frame
Baseline through Day 43
2

PK: Maximum Concentration of RAY1225

Time frame
Baseline through Day 43

Secondary outcomes

1

Number and severity of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events(SAE)

Time frame
Baseline through Day 43

Other outcomes

Locations

This trial has no locations.

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: