drugset
drugset / Trial / NCT04909242

Assessing the Safety, Tolerability and Pharmacokinetics(PK) of DZD9008 and the Effect of Low-fat Meal on PK of DZD9008 in Healthy Adult Participants

NCT04909242 ↗

Phase 1 Completed 78 enrolled Dizal Pharmaceuticals
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a Phase 1, randomised, double-blind, placebo-controlled, single ascending dose sequential group study in healthy participants. This study consists of three parts: Part A (single dose escalation, SAD) , Part B (food effect, FE) and Part C (relative bioavailability, BA).

Timeline

Start
2021-04-21
Primary completion
2022-02-07
Completion
2022-02-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Sunvozertinib Small molecule 50 mg Oral
Subject Sunvozertinib Small molecule 100 mg Oral
Subject Sunvozertinib Small molecule 200 mg Oral
Subject Sunvozertinib Small molecule 300 mg Oral
Subject Sunvozertinib Small molecule 400 mg Oral

Indications

No indication recorded.