Healthy VolunteersPhase 1NCT04909242
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 study testing DZD9008 in people with Healthy Volunteers, run by Dizal Pharmaceuticals at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- DZD9008
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2021to 7 Feb 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Randomised, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of DZD9008 Following Single Ascending Dose and the Effect of Low-fat Meal on Pharmacokinetics of DZD9008 in Healthy Adult Participants
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
- Healthy Volunteers
- Being tested
- DZD9008, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DZD9008Drug
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.
PlaceboDrug
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.
DZD9008Drug
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.
DZD9008Drug
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).
| Study group | Role | What they receive |
|---|---|---|
| single oral dose of DZD9008 | Experimental | single dose of DZD9008 (50 mg, 100 mg, 200 mg, 300 mg and 400 mg, tablet) Receives: Drug: DZD9008 |
| single oral dose of placebo | Placebo comparator | single dose of placebo (matching placebo, 50 mg, 100 mg, 200 mg, 300 mg and 400 mg, tablet) Receives: Drug: Placebo |
| single oral dose of DZD9008 (300 mg, tablet) | Experimental | Not described Receives: Drug: DZD9008 |
| single oral dose of DZD9008 (100 mg, tablet or suspension) | Experimental | Not described Receives: Drug: DZD9008 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 14 days after study drug administration
Secondary outcomes (8)
Maximum plasma concentration (Cmax) of DZD9008
Measured: up to 10 days after study drug administration
Time to reach maximum plasma concentration (tmax)
Measured: 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)
Measured: up to 10 days after study drug administration
Area under the concentration-time curve from time 0 to infinity (AUC0-inf)
Measured: up to 10 days after study drug administration
Apparent total plasma clearance (CL/F)
Measured: up to 10 days after study drug administration
Apparent volume of distribution (Vz/F)
Measured: up to 10 days after study drug administration
Mean residence time (MRT)
Measured: up to 10 days after study drug administration
Terminal elimination half-life (t1/2)
Measured: up to 10 days after study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start21 Apr 2021
- Primary completion7 Feb 2022
- Study completion7 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Dizal PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dizal Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel Dickerson, Principal investigator, PRA Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04909242
- Sponsor's protocol ID
- DZ2021E0004
- Status last verified
- May 2022
- First submitted
- 13 May 2021
- Last updated
- 2 Jun 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Randomised, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of DZD9008 Following Single Ascending Dose and the Effect of Low-fat Meal on Pharmacokinetics of DZD9008 in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT04909242
- Acronym / sponsor ID
- DZ2021E0004
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Dizal PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 7 Feb 2022 (actual)
- Study completion
- 7 Feb 2022 (actual)
- First posted
- 1 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| single oral dose of DZD9008 | Experimental | Drug: DZD9008single dose of DZD9008 (50 mg, 100 mg, 200 mg, 300 mg and 400 mg, tablet) |
| single oral dose of placebo | Placebo comparator | Drug: Placebosingle dose of placebo (matching placebo, 50 mg, 100 mg, 200 mg, 300 mg and 400 mg, tablet) |
| single oral dose of DZD9008 (300 mg, tablet) | Experimental | Drug: DZD9008 |
| single oral dose of DZD9008 (100 mg, tablet or suspension) | Experimental | Drug: DZD9008 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (13 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DZD9008In 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 | single oral dose of DZD9008 |
| PlaceboIn 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 | single oral dose of placebo |
| DZD9008In 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 | single oral dose of DZD9008 (100 mg, tablet or suspension) |
| DZD9008Healthy 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). | Drug | single oral dose of DZD9008 (300 mg, tablet) |
Primary outcome
Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: up to 14 days after study drug administration
To assess the safety and tolerability of DZD9008 following oral administration of single ascending doses in healthy adult participants.
Number of participants with clinically significant laboratory assessment abnormalities
Time frame: up to 14 days after study drug administration
To assess the safety and tolerability of DZD9008 following oral administration of single ascending doses in healthy adult participants.
Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities
Time frame: up to 14 days after study drug administration
To assess the safety and tolerability of DZD9008 following oral administration of single ascending doses in healthy adult participants.
Number of participants with clinically significant abnormalities in LVEF
Time frame: up to 14 days after study drug administration
To assess the safety and tolerability of DZD9008 following oral administration of single ascending doses in healthy adult participants.
Number of participants with clinically significant abnormalities in FEV1%
Time frame: up to 14 days after study drug administration
To assess the safety and tolerability of DZD9008 following oral administration of single ascending doses in healthy adult participants.
8 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- Individual participant dataSharing planned: No
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Screening Protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Dickerson principal investigator
PRA Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DZD9008 in people with Healthy Volunteers, run by Dizal Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: up to 14 days after study drug administration). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2022.