A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics of DZD8586 in Healthy Adult Participants
NCT05176873 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64
Last updated 2023-09-07
Summary
This is a study in healthy adult participants. This is the first time this drug has ever been tested in human, and so it will help to understand what type of side effects may occur with this intervention. It will also measure the levels of drug in the body.
Conditions
- Lymphoma, Non-Hodgkin
Interventions
- DRUG
-
DZD8586
Single dose of DZD8586. Starting dose of DZD8586 is 20mg. If tolerated, subsequent cohorts will test increasing doses of DZD8586.
- DRUG
-
A single oral dose of placebo will be given.
Sponsors & Collaborators
-
Dizal (Jiangsu) Pharmaceutical Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Frank Lee · Frontage Clinical Services, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2021-12-09
- Primary Completion
- 2022-05-11
- Completion
- 2022-05-22
- FDA Drug
- Yes
Countries
- United States
Study Locations
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