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The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of LAE102 injection in healthy and overweight/obese participants, and also evaluate the preliminary pharmacodynamic effect of multiple dose injections in overweight/obese participants.
Part A is a randomized, double-blinded, placebo-controlled, single ascending dose by Intravenous (IV) administration in 40 Healthy participants;
Part B is a randomized, double-blinded, placebo-controlled, single ascending dose by subcutaneous (SC) administration in 24 Healthy participants;
Part C is a randomized, double-blind, placebo-controlled, multiple dose ascending and expanding by subcutaneous (SC) administration in 60 overweight/obese participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A LAE102 IV | Experimental | Single dose LAE102 by IV administration |
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| Part A placebo IV | Placebo Comparator | Single dose placebo by IV administration |
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| Part B LAE102 SC | Experimental | Single dose LAE102 by SC administration |
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| Part B placebo SC | Placebo Comparator | Single dose placebo by SC administration |
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| Part C LAE102 SC | Experimental | Multiple dose LAE102 by SC administration |
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| Part C placebo SC | Placebo Comparator | Multiple dose placebo by SC administration |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LAE102 intravenous administration | Drug | A single dose of LAE102 administered intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number & severity of participants with treatment-related adverse events as assessed by CTCAE V5.0 | Findings on physical examination, ECG, vital signs, and reports of the laboratory results based on the CTCAE v5.0 | From Day 1 to Day 29 for single dose part. From Day 1 to Day 196 for multiple dose part |
| Measure | Description | Time Frame |
|---|---|---|
| characterize the peak of serum concentration (Cmax) of LAE102 injection in healthy subjects | For both intravenously guttae & subcutaneous injection, to evaluate the maximum observed serum concentration(Cmax) | From pre-dose to Day 29 for single dose part. From pre-dose to Day 196 for multiple dose part. |
| characterize the area under the serum concentration versus time curve (AUC) of LAE102 injection in healthy subjects |
| Measure | Description | Time Frame |
|---|---|---|
| Preliminary pharmacodynamic of total body weight for multiple dose part | Changes and percentage changes in total body weight (kg) after administration | From pre-dose to Day 168. |
| Preliminary pharmacodynamic of lean mass for multiple dose part |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Qiu, BS | Contact | +8617310793626 | li.qiu@laekna.com |
| Name | Affiliation | Role |
|---|---|---|
| Xuening Li, Professor | Zhongshan hospital affiliated to Fundan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan Zhongshan Hospital | Recruiting | Shanghai | Shanghai Municipality | 201203 | China |
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| placebo intravenous administration | Drug | A single dose of placebo administered intravenously |
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| LAE102 subcutaneous administration | Drug | Single dose of LAE102 administered subcutaneously |
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| placebo subcutaneous administration | Drug | single dose of placebo administered subcutaneously |
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| LAE102 multiple subcutaneous administration | Drug | Multiple dose of LAE102 administered subcutaneously |
|
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| Placebo multiple subcutaneous administration | Drug | Multiple dose of placebo administered subcutaneously |
|
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For both intravenously guttae & subcutaneous injection, to evaluate the area under the serum concentration versus time curve (AUC) |
| From pre-dose to Day 29 for single dose part. From pre-dose to Day 196 for multiple dose part. |
| evaluate the expression levels of Activin A in blood samples | The validated methodology was employed to assay serum levels of Activin A in biological samples. | From pre-dose to Day 29 for single dose part. From pre-dose to Day 196 for multiple dose part. |
| Incidence of positive Anti-drug antibody(ADA) after administration | Test ADA status in biological sample via validated methodology | pre-dose to Day 29 for single dose part. From pre-dose to Day 196 for multiple dose part. |
Changes and percentage changes in lean mass after administration
| From pre-dose to Day 168. |
| Preliminary pharmacodynamic of fat mass for multiple dose part | Changes and percentage changes in fat mass after administration | From pre-dose to Day 168. |
| Preliminary pharmacodynamic of thigh muscle volume for multiple dose part | Changes and percentage changes in thigh muscle volume after administration | From pre-dose to Day 168 |
| Preliminary pharmacodynamic of bone mineral density(BMD) for multiple dose part | Changes and percentage changes in BMD after administration | From pre-dose to Day 168 |
| BMI/waist circumference change and percentage. | Assess the Body Mass Index (BMI)/waist circumference change and percentage. | From pre-dose to Day 29 forsingle dose. From pre-dose to Day 196 for multiple dose. |
| ID | Term |
|---|---|
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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