Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HMPL-011 · 1 trial · 1 indication
Peak Plasma Concentration (Cmax) of HMPL-011 tablets (600 mg tablet X 2) and capsules (200 mg capsule X 6) in fasted States.
Peak Plasma Concentration (Cmax) of HMPL-011 tablets (600 mg tablet X 2) and capsules (200 mg capsule X 6) in fed States.
Steady State concentration of HMPL-011 will be caculated based on Ctrough
Area under the plasma concentration versus time curve (AUC) of HMPL-011 tablets (600 mg tablet X 2) and capsules (200 mg capsule X 6) in fed States.
Area under the plasma concentration versus time curve (AUC) of HMPL-011 tablets (600 mg tablet X 2) and capsules (200 mg capsule X 6) in fasted States.
| Arm | Type | Description |
|---|---|---|
| HMPL-011 tablets | ACTIVE_COMPARATOR | A sigle total oral dose of 1200 mg tablets (600 mg tablet X 2) |
| HMPL-011 capsules | ACTIVE_COMPARATOR | A sigle total oral dose of 1200 mg capsules (200 mg tablet X 6) |
| Name | Type | Description |
|---|---|---|
| HMPL-011 tablets | DRUG | Eligible subjects will recieve 1200 mg HMPL-011 tablets under fed and diet circumstance. |
| HMPL-011 capsules | DRUG | Eligible subjects will recieve 1200 mg HMPL-011 capsules under fed and diet circumstance. |
Inclusion Criteria: Subjects meeting the following criteria at the Screening Visit will be eligible to participate in the study: * Healthy adult male and female subjects, 18-70 years of age, inclusive, at the time of signing the informed consent; * Body weight ≥ 50 kg and body mass index (BMI) wit...
HMPL-011 is an investigational small molecule being developed for the treatment of Inflammatory Bowel Diseases. It is currently in Phase 1 clinical development, meaning it is still being studied and has not been approved for any use.
HMPL-011 is being developed by HUTCHMED (China) Limited, a biopharmaceutical company listed on the stock exchange under the ticker HCM. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.
HMPL-011 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and potential effectiveness in treating Inflammatory Bowel Diseases.
HMPL-011 has one completed Phase 1 clinical trial registered under NCT03860532, titled 'Phase I Clinical Trial in Healthy Male Volunteers.' This trial enrolled 24 participants and was a randomized, double-blind, active-controlled study that included biomarker selection.
HMPL-011 is the primary name for this investigational drug. No alternative names have been reported for this compound, which is being developed by HUTCHMED (China) Limited for the treatment of Inflammatory Bowel Diseases.