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

PHASE1CompletedINTERVENTIONAL
Enrollment

78

Participants

Timeline

Start Date

April 21, 2021

Primary Completion Date

February 7, 2022

Study Completion Date

February 7, 2022

Conditions
Healthy Volunteers
Interventions
DRUG

DZD9008

In the double blind, randomised, placebo-controlled trial (Part A - SAD), healthy adult participants will be randomized to receive DZD9008 at different dose levels. There are 5 planned dose cohorts, starting from 50 mg once daily. If tolerated, subsequent cohorts will test increasing doses of DZD9008 or matching placebo, namely 100 mg, 200 mg, 300 mg and 400 mg.

DRUG

Placebo

In the double blind, randomised, placebo-controlled trial (Part A - SAD), healthy adult participants will be randomized to receive matching placebo for DZD9008 at different dose levels. There are 5 planned dose cohorts of matching placebo for DZD9008, starting from 50 mg once daily.

DRUG

DZD9008

In Part C, healthy adult participants will be enrolled to receive a single dose of DZD9008 as suspension in period 1 and as tablet in period 2.

DRUG

DZD9008

Healthy adult participants will be randomized to receive DZD9008 single dose at a defined dose under a cross-over condition with or without food (low-fat in Part B; high-fat in Part D).

Trial Locations (1)

66219

PRA Health Sciences, Lenexa

Sponsors
All Listed Sponsors
lead

Dizal Pharmaceuticals

INDUSTRY

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 | Biotech Hunter | Biotech Hunter