NCT04932005

A Study of DZD2269 in Healthy Adult Participants

A Phase 1 Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of DZD2269 Oral Tablet Following Single and Multiple Ascending Dose Administration to Healthy Adult Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Dizal Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a research study in healthy participants. The purpose of this study is to see how safe the study drug is and how well it is tolerated after dosing. This study will also investigate pharmacokinetics of DZD2269; renal excretion of DZD2269 will also be evaluated. The study will also measure biomarkers such as pCREB in the blood.

Detailed description

A phase 1, randomized, double-blinded, placebo-controlled, study in healthy participants. This study includes two parts, Part A (single ascending dose escalation) and Part C (multiple ascending dose escalation).

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	DZD2269	Part A: A single oral dose at 5mg, 10mg, 20mg, 40mg, 80mg, 160mg. Part C: Twice daily dosing for 7 days at 10mg, 30mg, 80mg.
DRUG	placebo	Part A: A single oral dose. Part C: Twice daily dosing for 7 days.

Timeline

• Start date: 2021-06-29
• Primary completion: 2022-04-01
• Completion: 2022-04-12
• First posted: 2021-06-18
• Last updated: 2022-07-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study