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HMPL-011

Phase 1

Inflammatory Bowel Diseases | Small molecule | Gastrointestinal |HUTCHMED (China) Limited|Trials Updated: Mar 5, 2019

HMPL-011 target and mechanism

ModalitySmall molecule

Also known as HMPL-011 tablets

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

HMPL-011 clinical trials

HMPL-011 · 1 trial · 1 indication

Phase 1 1
NCT03860532Phase I Clinical Trial in Healthy Male VolunteersInflammatory Bowel Diseases
COMPLETED24 Analytics
PHASE1COMPLETED
Phase I Clinical Trial in Healthy Male Volunteers
Inflammatory Bowel DiseasesUnlock trial analytics

Study Endpoints

Primary Endpoints

Peak Plasma Concentration (Cmax) of HMPL-011 tablets vs capsules in fasted States
72 hours

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 vs capsules in fed States
72 hours

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
5 weeks

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 vs capsules in fed States.
72 hours

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 vs capsules in fasted States.
72 hours

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.

Secondary Endpoints

Overall incidence of TEAEs
5 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeDIAGNOSTIC

Treatment Arms

ArmTypeDescription
HMPL-011 tabletsACTIVE_COMPARATORA sigle total oral dose of 1200 mg tablets (600 mg tablet X 2)
HMPL-011 capsulesACTIVE_COMPARATORA sigle total oral dose of 1200 mg capsules (200 mg tablet X 6)

Interventions

NameTypeDescription
HMPL-011 tabletsDRUGEligible subjects will recieve 1200 mg HMPL-011 tablets under fed and diet circumstance.
HMPL-011 capsulesDRUGEligible subjects will recieve 1200 mg HMPL-011 capsules under fed and diet circumstance.
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersYes

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...

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Frequently asked questions about HMPL-011

What is HMPL-011 used for?

HMPL-011 is an investigational small molecule being studied for inflammatory bowel diseases, a group of gastrointestinal conditions. It has been evaluated in a Phase 1 clinical trial in healthy male volunteers. HMPL-011 is not approved for any indication and remains in clinical development.

Who makes HMPL-011?

HMPL-011 is developed by HUTCHMED (China) Limited, which trades under the ticker HCM. The company is the sponsor of the clinical program for this small molecule candidate in inflammatory bowel diseases.

What phase is HMPL-011 in?

HMPL-011 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are ongoing. The program has enrolled 24 participants in total and remains investigational, meaning it is not approved for commercial use.

What clinical trials is HMPL-011 in?

HMPL-011 has been studied in one clinical trial, NCT03860532, titled Phase I Clinical Trial in Healthy Male Volunteers. The trial was a completed Phase 1 study with 24 enrolled participants, using a randomized, double-blind, active-controlled design in healthy volunteers.

Is HMPL-011 the same as HMPL-011 tablets?

Yes, HMPL-011 tablets is an alternative name for HMPL-011, the investigational small molecule developed by HUTCHMED (China) Limited for inflammatory bowel diseases. Both names refer to the same Phase 1 drug candidate.