Trials / Unknown
UnknownNCT04173455
Study of the Safety, Tolerability and Pharmacokinetics of HZ-A-018 in Patients With B Cell Lymphoma
Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of Bruton Tyrosine Kinase (BTK) Inhibitor HZ-A-018 in Patients With B-Cell Lymphoma
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 46 (estimated)
- Sponsor
- First Affiliated Hospital of Zhejiang University · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to establish the safety, tolerability, pharmacokinetics and RP2D (Recommended Phase II Dose) of orally administered HZ-A-018 in patients with B cell lymphoma who have at least failed or relapsed after first-line treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HZ-A-018 | In the dose-escalation part, subjects will be assigned to five cohorts with increaing dose level to determine DLT and MTD during the first 28-day cycle. In the expansion part, subjects will be assigned to two fixed dose corhort. |
Timeline
- Start date
- 2019-10-28
- Primary completion
- 2021-09-01
- Completion
- 2022-02-01
- First posted
- 2019-11-22
- Last updated
- 2019-11-22
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04173455. Inclusion in this directory is not an endorsement.