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The main aim of this clinical trial is to assess the safety of PD5K3 in patients aged 18 to 65 years. The main questions it aims to answer are:
Participants will
This study is a first-in-human study, which is a single-center, randomized, placebo-controlled, double-blind, dose escalation, clinical study, aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of PD5K3 in healthy adult volunteers, compared with pegaspargase at the same dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PD5K3 group | Experimental | Eight subjects will be randomized to receive a single dose of PD5K3 in a double-blind fashion at each dose level. |
|
| PD5K3 Placebo group | Placebo Comparator | Two subjects will be randomized to receive placebo in a double-blind fashion at each dose level. |
|
| Pegaspargase group | Active Comparator | Four subjects will receive a single dose of pegaspargase at the each dose level, and the dose of pegaspargase is the same with PD5K3. This group is open-labelled. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD5K3 | Drug | Six dose levels will be evaluated. intravenous injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-related Adverse Events | To evaluate the adverse events as characterized by type, frequency, severity as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, timing, seriousness, and relationship to study therapy after administration. | up to 49 days |
| Measure | Description | Time Frame |
|---|---|---|
| The Area Under the Curve from dosing to the time of the last measured concentration (AUC0-t) | Pharmacokinetic parameter | up to 49 days |
| Maximum plasma concentration (Cmax) | Pharmacokinetic parameter |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liyan Miao | The First Affiliated Hospital of Soochow University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangshu | 215006 | China |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C042705 | pegaspargase |
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PD5K3 group and placebo control group are double-blinded, while the active comparator group is open-labeled.
| Placebo |
| Drug |
intravenous injection |
|
| Pegaspargase | Drug | Six dose levels will be evaluated. intramuscular injection |
|
|
| up to 49 days |
| The half-life (t1/2) | Pharmacokinetic parameter | up to 49 days |
| Compare the plasma asparaginase activity between the PD5K3 and pegaspargase groups | Plasma asparaginase activities are determined by a validated enzymatic spectrophotometric assay, and the results are reported in IU/mL. In the assay, asparaginase hydrolyzes asparagine to generate aspartic acid, which can be detected colorimetrically using a coupled enzymatic reaction. | up to 49 days |
| Compare the plasma asparagine concentration between the PD5K3 and pegaspargase groups | Plasma asparagine concentration as a pharmacodynamic parameter | up to 49 days |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |