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

No results posted yet for this study

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

Placebo

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

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05176873 on ClinicalTrials.gov