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The trial is conducted in a single-center, randomized, double-blind, placebocontrolled, dose-increasing design. To evaluate the safety, tolerability, pharmacokinetics(PK) characteristics, efficacy and immunogenicity of PB-119 injection in Chinese obese subjects.
The trial is conducted in a single-center, randomized, double-blind, placebocontrolled, dose-increasing design. To evaluate the safety, tolerability, PK characteristics, efficacy and immunogenicity of PB-119 injection in Chinese obese subjects. The study consists of 1-2 cohort . 32 patients are planned to be included in each cohort (24 patients receive study drug,8 patients receive placebo) Subjects will receive treatment for 20 weeks after screening and complete 4 weeks of safety follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PB-119 | Experimental | PB-119 administered on the first day of week 1-20 according to the dose-escalation design |
|
| Placebo | Placebo Comparator | Matched placebo administered on the first day of week 1-20 according to the dose-escalation design |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PB-119 | Drug | Administered subcutaneously once a week |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | From the first dosing (Day 1 ) of study drug until completion of the post treatment follow-up visit (24 week) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic profile | Cmax | From the first dose (Day 1 ) of study drug until 20 week |
| Pharmacokinetic profile | Tmax | From the first dose (Day 1 ) of study drug until 20 week |
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Inclusion Criteria:
Chinese male or female subjects aged 18-60 years (both inclusive).
Body weight ≥70 kg(male) or 60 kg(female), and body mass index (BMI)
≥30.0 kg/m2 at screening.
Weight change <5% in the past 3 months before screening.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Guoping Yang, Ph D | The Third Xiangya Hospital of Central South University | Principal Investigator |
| Ping Jin, Ph D | The Third Xiangya Hospital of Central South University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third XIANGYA Hospital of Central South University | Changsha | Hunan | 410013 | China |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Drug |
Administered subcutaneously once a week |
|
| Pharmacokinetic profile | area under the curve0(AUC0)-tau | From the first dose (Day 1 ) of study drug until 20 week |
| Pharmacokinetic profile | AUC0-last | From the first dose (Day 1 ) of study drug until 20 week |
| Effectiveness index | Change in body weight from baseline | week 20 |
| Effectiveness index | Proportion of participants with ≥5% weight loss | week 20 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |