Health TrialsbyHealthPanel

Bioequivalence Study of BGM0504 Injection

ConditionOverweight/Obesity
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorBrightGene Bio-Medical Technology Co., Ltd.

About this trial

This is a study to evaluate the bioequivalence of a single subcutaneous injection of BGM0504 multi-dose pen (experimental formula T1) and BGM0504 single-dose pen (experimental formula T2) with BGM0504 single-dose pen (reference formula R).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-55 years (inclusive).

Male weight ≥50 kg, female weight ≥45 kg, and overweight (24.0 ≤ BMI < 28.0 kg/m²) or obese (BMI ≥ 28.0 kg/m²).

From signing the ICF until 3 months after dosing, no pregnancy plan and willing to use effective contraception to avoid pregnancy or causing partner pregnancy, and no plan for sperm/egg donation.

The participant fully understands the trial purpose, nature, methods, and potential adverse reactions, can complete the trial according to the protocol, has good living habits, can maintain good communication with the investigator, and voluntarily signs the ICF.

Disqualifiers

History of severe allergies or severe specific allergic diseases/history (asthma, urticaria, eczematous dermatitis, etc.) or allergic constitution (allergic to two or more foods or drugs), known or suspected allergy to any excipient of BGM0504 Injection.

Previous diagnosis of type 1 or type 2 diabetes, or clinically significant abnormal HbA1c at screening.

Family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 syndrome.

History of acute/chronic pancreatitis, pancreatic injury, or other high-risk factors for pancreatitis.

Trial design

Design model

Parallel

Treatments tested in this trial

  • BGM0504 Injection multi-dose pen

    Drug

    5 mg, single subcutaneous injection in the abdominal region

  • BGM0504 Injection single-dose pen

    Drug

    5 mg, single subcutaneous injection in the abdominal region

  • BGM0504 Injection single-dose pen

    Drug

    5 mg, single subcutaneous injection in the abdominal region

Treatment groups

144 Participants
are divided into 3 treatment groups
Group A: Group AExperimental treatment 1 intervention
Group B: Group BExperimental treatment 1 intervention
Group C: Group CActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Peak Plasma Concentration (Cmax)

Peak Plasma Concentration (Cmax)

Time frame
0 to 672 hours
2

Area under the plasma concentration versus time curve (AUC)0-t

Area under the plasma concentration versus time curve (AUC)0-t

Time frame
0 to 672 hours

Secondary outcomes

1

Monitor all the adverse event

Monitor all the adverse event was assessed by the investigator.

Time frame
29 days

Other outcomes

Sponsors and contacts

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

BrightGene Bio-Medical Technology Co., Ltd.

Lead sponsor

BrightGene Pharmaceutical Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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