HealthyPhase 1NCT05607589
The Safety, Tolerability, PK, and PD of DWP213388 After SAD and MAD Administration in Healthy Adult Subjects
A Phase 1 study testing DWP213388 in people with Healthy, run by Daewoong Pharmaceutical Co. LTD..
Trial summary
A Phase 1, First-in-human, Randomized, Double-blind, Placebo controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DWP213388 after Single and Multiple Ascending Oral Dose Administration in Healthy Adult Subjects Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- DWP213388
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2022to 8 Mar 2024
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing to sign an Institutional Review Board (IRB) approved informed consent form (ICF) on a voluntary basis and to voluntarily participate in the study, after being fully informed of and completely understanding this study, prior to any screening procedure being undertaken.
- Healthy adult male or female subject, of any race, between 18 to 65 years of age, inclusive at time of signing the ICF and prior to study intervention administration.
- Body mass index (BMI) between 18.0 and 34.9 kg/m2 at Screening.
- Subject who is determined to be in good health based on the results of medical history, physical examinations, 12-lead ECG, vital signs, and clinical laboratory evaluations at Screening or Day -1 as assessed by the Investigator (or designee).
Who cannot join
- Subject has significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
- attacks
- Subject has fasting blood glucose > 110 mg/dL (> 6.1 mmol/L) (confirmed with repeat testing if required) at Screening.
- Subject has a history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee). Please note subjects with allergies which can be managed without treatment can be included based on the decision of the Investigator (or designee).
- Subject has a history of stomach or intestinal surgery or resection, including cholecystectomy, that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
About this study
Official title: A Phase 1, First-in-human, Randomized, Double-blind, Placebo Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DWP213388 After SAD and MAD in Healthy Adult Subjects
A Phase 1, First-in-human, Randomized, Double-blind, Placebo controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DWP213388 after Single and Multiple Ascending Oral Dose Administration in Healthy Adult Subjects
Read the detailed description
DWP213388 will be administered to the study subjects, according to a randomized, double-blind, and placebo-controlled design. The administration will be a single or multiple oral doses for healthy subjects.
- Conditions
- Healthy
- Being tested
- DWP213388, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWP213388Drug
immunosuppressant
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| DWP213388 | Experimental | Each cohort, healthy subjects will be administered DWP213388 (6 subjects per each cohort) SAD Cohort 1: DWP213388 x mg QD Cohort 2: DWP213388 x mg QD Cohort 3: DWP213388 x mg QD Cohort 4: DWP213388 x mg QD Cohort 5: DWP213388 x mg QD
MAD Cohort 6: DWP213388 x mg QD Cohort 7: DWP213388 x mg QD Cohort 8: DWP213388 x mg QD Cohort 9: DWP213388 x mg QD Receives: Drug: DWP213388 |
| Placebo | Placebo comparator | Each cohort, healthy subjects will be administered placebo (2 subjects per each cohort) SAD Cohort 1: Placebo QD Cohort 2: Placebo QD Cohort 3: Placebo QD Cohort 4: Placebo QD Cohort 5: Placebo QD
MAD Cohort 6: Placebo QD Cohort 7: Placebo QD Cohort 8: Placebo QD Cohort 9: Placebo QD Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
TEAE
Incidence and severity
Measured: up to 7 days from the last dosing
12-lead ECG
PR interval, QRS interval, RR interval, QT interval, and QTcF
Measured: up to 7 days from the last dosing
Secondary outcomes (3)
Cmax
Drug concentration in Blood and urine
Measured: up to 72 hours from the last dosing
AUC
Area under curve
Measured: up to 72 hours from the last dosing
CL/F
Clearance
Measured: up to 72 hours from the last dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study startOct 2022 (estimated)
- Primary completion20 Feb 2024 (estimated)
- Study completion8 Mar 2024 (estimated)
Why it stopped: Withdrawal of Clinical Trial due to Licensing Out
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Goldwater Ronald, Principal investigator, Parexel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05607589
- Sponsor's protocol ID
- DW_DWP213388101
- Status last verified
- Nov 2024
- First submitted
- 19 Oct 2022
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-in-human, Randomized, Double-blind, Placebo Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DWP213388 After SAD and MAD in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT05607589
- Acronym / sponsor ID
- DW_DWP213388101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawal of Clinical Trial due to Licensing Out
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- Oct 2022 (estimated)
- Primary completion
- 20 Feb 2024 (estimated)
- Study completion
- 8 Mar 2024 (estimated)
- First posted
- 7 Nov 2022 (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.
A Phase 1, First-in-human, Randomized, Double-blind, Placebo controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DWP213388 after Single and Multiple Ascending Oral Dose Administration in Healthy Adult Subjects
Detailed description
DWP213388 will be administered to the study subjects, according to a randomized, double-blind, and placebo-controlled design. The administration will be a single or multiple oral doses for healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DWP213388 | Experimental | Drug: DWP213388Each cohort, healthy subjects will be administered DWP213388 (6 subjects per each cohort) SAD Cohort 1: DWP213388 x mg QD Cohort 2: DWP213388 x mg QD Cohort 3: DWP213388 x mg QD Cohort 4: DWP213388 x mg QD Cohort 5: DWP213388 x mg QD MAD Cohort 6: DWP213388 x mg QD Cohort 7: DWP213388 x mg QD Cohort 8: DWP213388 x mg QD Cohort 9: DWP213388 x mg QD |
| Placebo | Placebo comparator | Other: PlaceboEach cohort, healthy subjects will be administered placebo (2 subjects per each cohort) SAD Cohort 1: Placebo QD Cohort 2: Placebo QD Cohort 3: Placebo QD Cohort 4: Placebo QD Cohort 5: Placebo QD MAD Cohort 6: Placebo QD Cohort 7: Placebo QD Cohort 8: Placebo QD Cohort 9: Placebo QD |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Willing to sign an Institutional Review Board (IRB) approved informed consent form (ICF) on a voluntary basis and to voluntarily participate in the study, after being fully informed of and completely understanding this study, prior to any screening procedure being undertaken.
- Healthy adult male or female subject, of any race, between 18 to 65 years of age, inclusive at time of signing the ICF and prior to study intervention administration.
- Body mass index (BMI) between 18.0 and 34.9 kg/m2 at Screening.
- Subject who is determined to be in good health based on the results of medical history, physical examinations, 12-lead ECG, vital signs, and clinical laboratory evaluations at Screening or Day -1 as assessed by the Investigator (or designee).
Key exclusion criteria (5 listed)
- Subject has significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
- attacks
- Subject has fasting blood glucose > 110 mg/dL (> 6.1 mmol/L) (confirmed with repeat testing if required) at Screening.
- Subject has a history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee). Please note subjects with allergies which can be managed without treatment can be included based on the decision of the Investigator (or designee).
- Subject has a history of stomach or intestinal surgery or resection, including cholecystectomy, that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
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 |
|---|---|---|
| DWP213388immunosuppressant | Drug | DWP213388 |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
TEAE
Time frame: up to 7 days from the last dosing
Incidence and severity
12-lead ECG
Time frame: up to 7 days from the last dosing
PR interval, QRS interval, RR interval, QT interval, and QTcF
3 secondary outcomes
Cmax
Time frame: up to 72 hours from the last dosing
AUC
Time frame: up to 72 hours from the last dosing
CL/F
Time frame: up to 72 hours from the last dosing
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
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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.
Goldwater Ronald principal investigator
Parexel
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DWP213388 in people with Healthy, run by Daewoong Pharmaceutical Co. LTD..
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 4 inclusion and 5 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: withdrawn, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
TEAE (time frame: up to 7 days from the last dosing). The study lists 2 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 5 Nov 2024.