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The primary objective of this study is: to evaluate the safety and tolerability of injectable SPN01 in subjects. The secondary objective of this study is: to evaluate the pharmacokinetic characteristics of injectable SPN01 in subjects.The exploratory objectives of this study are: (1)to evaluate the preliminary efficacy of injectable SPN01 in subjects with colorectal cancer. (2) to evaluate the effect of the blood concentration of injectable SPN01 on the QTc interval. (3) to evaluate the metabolic characteristics of injectable SPN01 in humans.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 | Experimental | Healthy subjects will receive intravenous injection of different doses of injectable SPN01 and placebo in a single dose. |
|
| Phase 2 | Experimental | Colorectal cancer subjects will receive intravenous injection of SPN01 0.06 mg/kg for a single dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPN01 for Injection | Drug | After each subject was randomly assigned, different doses of SPN01 for Injection (0.02 mg/kg, 0.06 mg/kg, 0.12 mg/kg) were administered intravenously in a single dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | Safety and tolerability will be assessed through the monitoring of adverse events (AEs), clinical laboratory tests (including complete blood count, blood biochemistry, coagulation function, and urinalysis), local safety assessments, vital sign checks (including temperature, respiration rate, pulse rate, and blood pressure), 12-lead electrocardiogram (ECG), and physical examinations. Adverse events (AEs) and serious adverse events (SAEs) will be evaluated according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0. All adverse events occurring during the clinical trial will be recorded, including their clinical manifestations, severity, onset and resolution times, management measures, and outcomes. The correlation between AEs and the investigational drug will also be determined. | Predose and up to 24 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic - Primary Parameters | Cmax | For healthy subjects: Predose and up to 24 hours postdose; For colorectal cancer subjects: Predose and up to 4 hours postdose |
| Pharmacokinetic - Primary Parameters |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Endpoints | Evaluation of Tumor Imaging Effects During Surgery | During Surgery |
| Exploratory Endpoints | Assessment of the Relationship Between SPN01 Plasma Concentration and QTc Interval Effects (if applicable) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liu | Contact | 010-84059200 | liurenfa@pku.edu.cn |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Placebo | Other | After each subject was randomly assigned, a single intravenous injection of 0.9% sodium chloride was administered |
|
| SPN01 for Injection | Drug | Colorectal cancer subjects will receive intravenous injection of SPN01 0.06 mg/kg for a single dose. |
|
AUC(0-t)
| For healthy subjects: Predose and up to 24 hours postdose; For colorectal cancer subjects: Predose and up to 4 hours postdose |
| Pharmacokinetic - Primary Parameters | AUC(0-∞) | For healthy subjects: Predose and up to 24 hours postdose; For colorectal cancer subjects: Predose and up to 4 hours postdose |
| Pharmacokinetic - Secondary Parameters | Tmax | For healthy subjects: Predose and up to 24 hours postdose; For colorectal cancer subjects: Predose and up to 4 hours postdose |
| Pharmacokinetic - Secondary Parameters | AUC_%Extrap | For healthy subjects: Predose and up to 24 hours postdose; For colorectal cancer subjects: Predose and up to 4 hours postdose |
| Pharmacokinetic - Secondary Parameters | CL | For healthy subjects: Predose and up to 24 hours postdose; For colorectal cancer subjects: Predose and up to 4 hours postdose |
| Pharmacokinetic - Secondary Parameters | Vd | For healthy subjects: Predose and up to 24 hours postdose; For colorectal cancer subjects: Predose and up to 4 hours postdose |
| Pharmacokinetic - Secondary Parameters | MRT | For healthy subjects: Predose and up to 24 hours postdose; For colorectal cancer subjects: Predose and up to 4 hours postdose |
| Pharmacokinetic - Secondary Parameters | λz | For healthy subjects: Predose and up to 24 hours postdose; For colorectal cancer subjects: Predose and up to 4 hours postdose |
| Pharmacokinetic - Secondary Parameters | T1/2 | For healthy subjects: Predose and up to 24 hours postdose; For colorectal cancer subjects: Predose and up to 4 hours postdose |
| Predose and up to 4 hours postdose |
| Exploratory Endpoints | Qualitative and Quantitative Analysis of Metabolites from Blood/Urine Samples | Predose and up to 4 hours postdose |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |