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This Phase Ib clinical trial aims to evaluate the safety, tolerability, and preliminary efficacy of JMKX000189 tablets in participants with chemotherapy-induced peripheral neuropathy (CIPN).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JMKX000189 Dose 1 | Experimental |
| |
| JMKX000189 Dose 2 | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JMKX000189 | Drug | JMKX000189 administered orally. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events (AEs) and serious adverse events (SAEs). | up to 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| The changes in average pain score on brief pain inventory-short form (BPI-SF) from the baseline | up to 6 months. | |
| The changes in numbness score on FACT/GOG-Ntx from the baseline | up to 6 months. |
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Inclusion Criteria:
Exclusion Criteria:
Presence of any type of peripheral neuropathy other than CIPN (e.g., diabetic, paraneoplastic, or nutritional).
Toxicities from prior anti-tumor therapy (excluding CIPN) > CTCAE Grade 1 within 2 weeks of first dose (excluding alopecia, skin pigmentation, stable hypothyroidism, or chronic events).
Participants with any of the following cardiovascular diseases or medical history:
Presence of active systemic infections.
History of or active primary/secondary immunodeficiency.
Participation in an interventional clinical trial within 1 month prior to screening.
Hypersensitivity to any component of the study drug (and its excipients).
Any condition deemed by the investigator to pose excessive risk, confound results, or interfere with compliance.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fawei Wu | Contact | +86 15720614080 | wufawei@jeyoupharma.com |
| Name | Affiliation | Role |
|---|---|---|
| Ruofan Huang | Huashan Hospital | Principal Investigator |
| Xiaojie Wu | Huashan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital Fudan University | Shanghai | China |
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| Placebo |
| Other |
Placebo administered orally. |
|
| Area Under the Curve over the Dosing Interval during Steady State (AUC0-tau) | up to 6 months. |
| Maximum Concentration during Steady State (Cmax,ss) | up to 6 months. |