A Phase 1 Study of GZC8072 Tablets Following a Single Dose in Healthy Study Participants and Multiple Doses in Obese/Overweight Study Participants

ConditionHealthy Subjects;Overweight or Obesity

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-55

SponsorGan & Lee Pharmaceuticals.

About this trial

This trial is conducted in China. This study plans to include 2 parts, i.e., a single-dose study and a multiple-dose study:

The single-dose study will be conducted in healthy adult participants to evaluate the safety, tolerability, and pharmacokinetic profile of single doses of GZC8072 Tablets; The multiple-dose study will be conducted in obese or overweight study participants to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic profiles of multiple doses of GZC8072 Tablets.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Provide written informed consent, fully understand the purpose and stipulated procedures of this study, and be willing to participate.

Male or female, aged 18-55 years (inclusive) at the time of signing the ICF.

Body mass index (BMI) at screening is 19.0-28.0 kg/m² (inclusive); and weight is ≥ 54.0 kg for males and ≥ 50.0 kg for females.

Participants must agree to take reliable contraceptive measures for themselves and their partners during the study and within 3 months after administration, and not donate sperm or eggs (egg cells, oocytes) for assisted reproductive purposes.

Disqualifiers

History of allergic diathesis, or allergic diseases such as bronchial asthma, urticaria, or eczema (except for mild seasonal allergies) prior to screening, or known or suspected allergy, intolerance, or hypersensitivity to GLP-1RA drugs, or excipients of the investigational medicinal product (IMP) at screening.

Participants with a previous or existing history of cardiovascular system, digestive system, respiratory system, urinary system, blood system, nervous system, psychiatric disorders, endocrine diseases (except obesity or overweight), malignant tumors and other diseases that are judged by the investigator to have an impact on the evaluation of the results of this study.

Hemorrhage tendency (including but not limited to non-traumatic hemorrhage) within 6 months before screening, or presence of diseases with increased hemorrhage tendency that are clearly diagnosed.

History of hypoglycemia (including symptomatic hypoglycemia) within 3 months prior to screening.

Trial design

Design model

Parallel

Treatments tested in this trial

GZC8072 Tablets
Drug
Oral drug
Placebo
Drug
Oral drug

Treatment groups

126 Participants

are divided into 2 treatment groups

Group A: GZC8072 TabletsExperimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention