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The purpose of this study is to evaluate safety, tolerability, immunogenicity, pharmacokinetics, pharmacodynamics, and efficacy of LP-001 in healthy volunteers. The study will be conducted in 2 parts: Part 1, the single ascending dose (SAD) is the first in human (FIH) study of LP-001 and Part 2, multiple ascending dose (MAD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: LP-001 Dose 1 (Single) | Experimental | Single dose administration of LP-001 with dose 1 |
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| Cohort 2: LP-001 Dose 2 (Single) | Experimental | Single dose administration of LP-001 with dose 2 |
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| Cohort 3: LP-001 Dose 3 (Single) | Experimental | Single dose administration of LP-001 with dose 3 |
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| Cohort 4: LP-001 Dose 4 (Single) | Experimental | Single dose administration of LP-001 with dose 4 |
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| Cohort 5: LP-001 Dose 5 (Single) | Experimental | Single dose administration of LP-001 with dose 5 |
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| Cohort 6: LP-001 Dose 6 (Single) | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LP-001 Dose 1 (Single) | Biological | A single dose of LP-001 (Dose 1) was administered subcutaneously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Number of subjects with treatment-related Treatment Emergent Adverse Events (TEAEs). | Observation for 36 days after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Time to peak concentration (Tmax) of LP-001 | The time when the blood drug concentration reaches its peak after a single dose of medication. | Observation for 36 days after administration |
| Maximum concentration (Cmax) of LP-001 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Public Health Clinical Center | Shanghai | China |
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Single dose administration of LP-001 with dose 6
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| Cohort 7: Placebo (Single) | Placebo Comparator | Single dose administration of placebo drug |
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| Cohort 8: LP-001 Dose 7 (Multiple) | Experimental | LP-001 with dose 7 was administered 4 times in total |
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| Cohort 9: LP-001 Dose 8 (Multiple) | Experimental | LP-001 with dose 8 was administered 4 times in total |
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| Cohort 10: Placebo (Multiple) | Placebo Comparator | Placebo drug was administered 4 times in total |
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| LP-001 Dose 2 (Single) | Biological | A single dose of LP-001 (Dose 2) was administered subcutaneously. |
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| LP-001 Dose 3 (Single) | Biological | A single dose of LP-001 (Dose 3) was administered subcutaneously. |
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| LP-001 Dose 4 (Single) | Biological | A single dose of LP-001 (Dose 4) was administered subcutaneously. |
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| LP-001 Dose 5 (Single) | Biological | A single dose of LP-001 (Dose 5) was administered subcutaneously. |
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| LP-001 Dose 6 (Single) | Biological | A single dose of LP-001 (Dose 6) was administered subcutaneously. |
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| Placebo (Single) | Biological | A single dose of placebo was administered subcutaneously. |
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| LP-001 Dose 7 (Multiple) | Biological | LP-001 (Dose 7) was administered multiple times subcutaneously. |
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| LP-001 Dose 8 (Multiple) | Biological | LP-001 (Dose 8) was administered multiple times subcutaneously. |
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| Placebo (Multiple) | Biological | Placebo was administered multiple times subcutaneously. |
|
The maximum concentration of LP-001 in the bloodstream after administration.
| Observation for 36 days after administration |
| Elimination half-life (t1/2) of LP-001 | The time required for the concentration of LP-005 in the bloodstream to decrease by half. | Observation for 36 days after administration |
| Area under the concentration-time curve (AUC0-t) of LP-001 | The time required for the concentration of LP-005 in the bloodstream to decrease by half. | Observation for 36 days after administration |
| Apparent clearance rate (CL/F) of LP-001 | The ratio of drug clearance to drug concentration, represents the apparent clearance of a drug after administration, adjusted for bioavailability. | Observation for 36 days after administration |
| Assessment of immunogenicity | The proportion of anti drug antibody (ADA) positive subjects at different detection time points. | Observation for 36 days after administration |
| Assessment of hemoglobin (Hb) change | Concentration of Hemoglobin changes from baseline at various time points of assessment. | Observation for 36 days after administration |
| Assessment of red blood cell (RBC) count change | The count of RBC changes from baseline at various time points of assessment. | Observation for 36 days after administration |
| Assessment of reticulocyte (Rtc) count change | The count of Rtc changes from baseline at various time points of assessment. | Observation for 36 days after administration |
| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D012847 | Single Person |
| ID | Term |
|---|---|
| D017533 | Marital Status |
| D005191 | Family Characteristics |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D012959 | Socioeconomic Factors |
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