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Monoclonal Antibodies

HMPL-523 for Low Platelet Count

Phase 1
Recruiting
Research Sponsored by Hutchmed
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 1 - week 24
Awards & highlights
No Placebo-Only Group

Summary

"This trial will test the safety, side effects, and effectiveness of HMPL-523 in adults with ITP at multiple locations with full transparency about the treatment being administered."

Who is the study for?
Adults with immune thrombocytopenia (ITP), a condition where the blood doesn't clot well due to low platelet count, can join this trial. Specific details on who can or cannot participate are not provided here.
What is being tested?
The study is testing HMPL-523's safety and how well it works in adults with ITP. It's an open-label, multicenter trial, meaning both researchers and participants know what treatment is being given.
What are the potential side effects?
Potential side effects of HMPL-523 aren't listed here but typically include reactions at the site of administration, bleeding issues due to low platelets, and possibly other immune-related effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 1 - week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 1 - week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Dose Limiting Toxicities
Safety and tolerability of HMPL-523 in adult subjects with primary ITP
Secondary study objectives
AUCtau (area under the concentration-time curve over a dosage interval)
Cmax (maximum plasma drug concentration)
Cmin (minimum plasma drug concentration)
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Dose optimization stageExperimental Treatment1 Intervention
In part 2 subjects will be randomized in a 1:1 ratio between the 2 dose levels selected at the end of part 1.
Group II: Dose escalationExperimental Treatment1 Intervention
Part 1 will consist of the following 3 dose levels: 300, 400, and 500 mg once daily (QD).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HMPL-523
2022
Completed Phase 1
~400

Find a Location

Who is running the clinical trial?

HutchmedLead Sponsor
36 Previous Clinical Trials
6,431 Total Patients Enrolled
William Schelman, MD, PhDStudy DirectorHutchmed
2 Previous Clinical Trials
803 Total Patients Enrolled
Vijay Jayaprakash, MD, PhDStudy DirectorHutchmed
~31 spots leftby Apr 2026
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