CompletedNCT04909242Updated Jun 2, 2022

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

A Phase 1 interventional study of DZD9008 and Placebo in Healthy Volunteers, sponsored by Dizal Pharmaceuticals. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-02.

Sponsored by Dizal Pharmaceuticals · Phase 1, Interventional, and Treatment

From the registry’s dates

Primary completion was Feb 2022, 4 years 8 months ago, and no results have been posted to the registry.

Phase: Phase 1
Study type: Interventional
Enrollment: 78
Allocation: Randomized
Ages: 18 Years to 60 Years
Sex: All

Study 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).

Conditions studied

Healthy Volunteers

In context

Lead sponsor

Dizal Pharmaceuticals is the lead sponsor of 37 studies on the registry; 15 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 1 (7%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 60 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Participants must be able to understand the nature of the trial and provide a signed and dated, written informed consent form before any study-specific procedures, sampling and analyses.
Provision of signed and dated written Optional Genetic Research informed consent prior to collection of samples for optional genetic research.
Healthy male or female participants aged 18 to 60 years (inclusive), with BMI 18.0 to 30.0 kg/m2 (inclusive). Body weight: ≥ 55 kg for male, ≥ 45 kg for female.
Healthy participants defined as the absence of acute or chronic clinically significant deviations from normal in medical history, physical examination, visual assessment, electrocardiogram (ECG), and clinical laboratory determinations at screening.
Participants must agree to practice effective contraception.
Normal baseline PFTs (≥ 80% predicted normal for spirometry, lung volumes).
Normal baseline ECG (QTcF \< 450 msec, PR \< 210 msec).
Non-smoker (not smoked within 3 months).
Liver biochemistry parameters: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN); Total bilirubin ≤ 1.5 × ULN
Adequate organ function including hepatic, renal, cardiac, visual and bone marrow function as determined by the investigator.

Exclusion criteria

Exclusion Criteria:

Ongoing or prior pulmonary disease including asthma, chronic obstructive pulmonary disease, interstitial lung disease and pneumonitis including but not limited to drug-related pneumonitis.
Women who are breast feeding.
Positive pregnancy test prior to study entry.
History of malignancy of any type, with the exception of the following: surgically excised non-melanomatous skin cancers more than 5 years prior to receiving IP.
A history of additional risk factors for TdP (e.g. heart failure, hypokalemia, family history of Long QT syndrome).
No prior history of atrial fibrillation within 6 months prior to first dosing of DZD9008
Manifestations of malabsorption due to prior GI surgery, GI disease, or for an unknown other reason that may affect the absorption of DZD9008-. Pulmonary infections or other active infection within 30 days of informed consent
History of bleeding disorder (including hemophilia, Von Willebrand disease, etc), history of stroke or intracranial haemorrhage within 6 months before study drug administration.
Judgement by the investigator that the participant is not likely to comply with study procedures, restrictions and requirements.
Positive serology or a known history of hepatitis B virus (HBV), hepatitis C virus (HCV), HIV.
Resting blood pressure > 140/90 mmHg at screening .
Resting pulse rate \< 45 beats per minute.
History of severe allergy or hypersensitivity reaction or ongoing allergy or hypersensitivity reaction, as judged by investigator, or history of hypersensitivity to EGFR/HER2/BTK inhibitors.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 78 participants (actual)

Study arms

Experimental
single oral dose of DZD9008
single dose of DZD9008 (50 mg, 100 mg, 200 mg, 300 mg and 400 mg, tablet)
Drug: DZD9008
Placebo comparator
single oral dose of placebo
single dose of placebo (matching placebo, 50 mg, 100 mg, 200 mg, 300 mg and 400 mg, tablet)
Drug: Placebo
Experimental
single oral dose of DZD9008 (300 mg, tablet)
Drug: DZD9008
Experimental
single oral dose of DZD9008 (100 mg, tablet or suspension)
Drug: DZD9008

Interventions

DrugDZD9008
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.
DrugPlacebo
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.
DrugDZD9008
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.
DrugDZD9008
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).

What researchers measure

Primary outcomes

Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs)
To assess the safety and tolerability of DZD9008 following oral administration of single ascending doses in healthy adult participants.
Time frame: up to 14 days after study drug administration
Number of participants with clinically significant laboratory assessment abnormalities
To assess the safety and tolerability of DZD9008 following oral administration of single ascending doses in healthy adult participants.
Time frame: up to 14 days after study drug administration
Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities
To assess the safety and tolerability of DZD9008 following oral administration of single ascending doses in healthy adult participants.
Time frame: up to 14 days after study drug administration
Number of participants with clinically significant abnormalities in LVEF
To assess the safety and tolerability of DZD9008 following oral administration of single ascending doses in healthy adult participants.
Time frame: up to 14 days after study drug administration
Number of participants with clinically significant abnormalities in FEV1%
To assess the safety and tolerability of DZD9008 following oral administration of single ascending doses in healthy adult participants.
Time frame: up to 14 days after study drug administration

Secondary outcomes

Maximum plasma concentration (Cmax) of DZD9008
Time frame: up to 10 days after study drug administration
Time to reach maximum plasma concentration (tmax)
Time frame: up to 10 days after study drug administration
Area under the concentration-time curve from time 0 (pre-dose) to the time of the dosing interval (AUC0-t)
Time frame: up to 10 days after study drug administration
Area under the concentration-time curve from time 0 to infinity (AUC0-inf)
Time frame: up to 10 days after study drug administration
Apparent total plasma clearance (CL/F)
Time frame: up to 10 days after study drug administration
Apparent volume of distribution (Vz/F)
Time frame: up to 10 days after study drug administration
Mean residence time (MRT)
Time frame: up to 10 days after study drug administration
Terminal elimination half-life (t1/2)
Time frame: up to 10 days after study drug administration

Study locations

1 site

PRA Health Sciences
Lenexa, Kansas 66219, United States

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04909242
Lead sponsor: Dizal Pharmaceuticals
Responsible party: Sponsor
First posted: Jun 1, 2021
Start date: Apr 21, 2021
Primary completion: Feb 7, 2022
Completion: Feb 7, 2022
Last update: Jun 2, 2022

Study contacts

Daniel Dickerson

principal investigator · PRA Health Sciences

Oversight

FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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