Healthy SubjectsPhase 1NCT04488900
Evaluation of the Safety and Tolerability of CKD-508 in Healthy Subjects
A Phase 1 study testing CKD-508 Capsule and CKD-508 Tablet in people with Healthy Subjects, run by Chong Kun Dang Pharmaceutical at 1 site in United Kingdom.
Trial summary
This study is a first-in-human, randomized, placebo-controlled, 4-part, single ascending dose and multiple ascending dose study. The study is designed to assess the safety, tolerability, PK, and PD and food effect of orally administered CKD-508 capsules and tablets in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- CKD-508 Capsule and CKD-508 Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Jul 2020to 2 Jul 2023
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject voluntarily agrees to participate in this study and signs an Independent Ethics Committee (IEC)-approved informed consent prior to performing any of the Screening Visit procedures.
- Males and females between 18 to 55 years of age, inclusive, at the Screening Visit.
- Females of non-childbearing potential (surgically sterile [hysterectomy or oophorectomy] or postmenopausal (amenorrhea for more than 12 months with follicle-stimulating hormone (FSH) in postmenopausal range confirmed by an FSH test).
- Males must be unable to procreate (defined as surgically sterile [i.e., had a vasectomy ≥6 months prior to screening]) or must agree to use highly effective form of birth control from screening through 90 days after study completion.
- Non-smokers (or other nicotine use) as determined by history (no nicotine use over the past 6 months).
Who cannot join
- Subject has clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological or psychiatric disorder(s) as determined by the PI or designee.
- Subject has any disorder that would interfere with the absorption, distribution, metabolism or excretion of drugs.
- Subject has any concurrent disease or condition that, in the opinion of the PI, would make the subject unsuitable for participation in the clinical study.
- Subject has history of alcohol and/or illicit drug abuse within 2 years of Screening Visit.
- Subject has positive test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody or human immunodeficiency virus (HIV) antibody.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Northwick Park Hospital
Harrow, Middlesex, HA1 3UJ
About this study
Official title: A Phase 1, First-in-Human, Double-blind, Randomized, Placebo Controlled Study to Assess the Safety, Tolerability, PK and PD and Food Effect of CKD-508 After Single and Multiple Ascending Oral Dose Administration in Healthy Adult Subjects
This study is a first-in-human, randomized, placebo-controlled, 4-part, single ascending dose and multiple ascending dose study. The study is designed to assess the safety, tolerability, PK, and PD and food effect of orally administered CKD-508 capsules and tablets in healthy subjects.
- Conditions
- Healthy Subjects
- Being tested
- CKD-508 Capsule, Placebo Capsule, CKD-508 Tablet, Placebo Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD-508 CapsuleDrug
Investigational drug
Placebo CapsuleDrug
Placebo
CKD-508 TabletDrug
Investigational drug
Placebo TabletDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Part 1. CKD-508 Capsule in Single Dose | Experimental | Single dose of CKD-508 capsules Receives: Drug: CKD-508 Capsule |
| Part 1. Placebo Capsule in Single Dose | Placebo comparator | Single dose of Placebo capsules Receives: Drug: Placebo Capsule |
| Part 2. CKD-508 Tablet in Single Dose | Experimental | Single dose of CKD-508 tablets for biocompartibility Receives: Drug: CKD-508 Tablet |
| Part 2. Placebo Tablet in Single Dose | Placebo comparator | Single dose of Placebo tablets for biocompartibility Receives: Drug: Placebo Tablet |
| Part 3. CKD-508 Tablet in Single Dose | Experimental | Single dose of CKD-508 tablets for food effect Receives: Drug: CKD-508 Tablet |
| Part 3. Placebo Tablet in Single Dose | Placebo comparator | Single dose of Placebo tablets for food effect Receives: Drug: Placebo Tablet |
| Part 4. CKD-508 Tablet in Multiple Dose | Experimental | Multiple dose of CKD-508 tablets Receives: Drug: CKD-508 Tablet |
| Part 4. Placebo Tablet in Multiple Dose | Placebo comparator | Multiple dose of placebo tablets Receives: Drug: Placebo Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability including treatment-emergent AE and treatment-emergent SAE
Measured: 28 days post the final dose
Secondary outcomes (5)
Maximum plasma CKD-508 concentrations after dosing
Peak plasma concentration (Cmax)
Measured: 28 days post the final dose
Time of maximum plasma CKD-508 concentrations after dosing
Time of peak plasma concentration (Tmax)
Measured: 28 days post the final dose
Changes from baseline in plasma CKD-508 concentrations in time after dosing
Area under the plasma concentration versus time curve (AUC)
Measured: 28 days post the final dose
Changes from baseline in CETP activity after dosing
Pharmacodynamics endpoint
Measured: 28 days post the final dose
Changes from baseline in lipid parameters after dosing
including, but not limited to the following: LDL-C, etc.
Pharmacodynamics endpoint
Measured: 14 days post the final dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start6 Jul 2020
- Primary completion2 Jul 2023
- Study completion2 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe 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
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04488900
- Sponsor's protocol ID
- A104-01DL2001
- Status last verified
- Feb 2024
- First submitted
- 22 Jul 2020
- Last updated
- 15 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-in-Human, Double-blind, Randomized, Placebo Controlled Study to Assess the Safety, Tolerability, PK and PD and Food Effect of CKD-508 After Single and Multiple Ascending Oral Dose Administration in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT04488900
- Acronym / sponsor ID
- A104-01DL2001
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 6 Jul 2020 (actual)
- Primary completion
- 2 Jul 2023 (actual)
- Study completion
- 2 Jul 2023 (actual)
- First posted
- 28 Jul 2020 (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 study is a first-in-human, randomized, placebo-controlled, 4-part, single ascending dose and multiple ascending dose study. The study is designed to assess the safety, tolerability, PK, and PD and food effect of orally administered CKD-508 capsules and tablets in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Part 1. CKD-508 Capsule in Single Dose | Experimental | Drug: CKD-508 CapsuleSingle dose of CKD-508 capsules |
| Part 1. Placebo Capsule in Single Dose | Placebo comparator | Drug: Placebo CapsuleSingle dose of Placebo capsules |
| Part 2. CKD-508 Tablet in Single Dose | Experimental | Drug: CKD-508 TabletSingle dose of CKD-508 tablets for biocompartibility |
| Part 2. Placebo Tablet in Single Dose | Placebo comparator | Drug: Placebo TabletSingle dose of Placebo tablets for biocompartibility |
| Part 3. CKD-508 Tablet in Single Dose | Experimental | Drug: CKD-508 TabletSingle dose of CKD-508 tablets for food effect |
| Part 3. Placebo Tablet in Single Dose | Placebo comparator | Drug: Placebo TabletSingle dose of Placebo tablets for food effect |
| Part 4. CKD-508 Tablet in Multiple Dose | Experimental | Drug: CKD-508 TabletMultiple dose of CKD-508 tablets |
| Part 4. Placebo Tablet in Multiple Dose | Placebo comparator | Drug: Placebo TabletMultiple dose of placebo tablets |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subject voluntarily agrees to participate in this study and signs an Independent Ethics Committee (IEC)-approved informed consent prior to performing any of the Screening Visit procedures.
- Males and females between 18 to 55 years of age, inclusive, at the Screening Visit.
- Females of non-childbearing potential (surgically sterile [hysterectomy or oophorectomy] or postmenopausal (amenorrhea for more than 12 months with follicle-stimulating hormone (FSH) in postmenopausal range confirmed by an FSH test).
- Males must be unable to procreate (defined as surgically sterile [i.e., had a vasectomy ≥6 months prior to screening]) or must agree to use highly effective form of birth control from screening through 90 days after study completion.
- Non-smokers (or other nicotine use) as determined by history (no nicotine use over the past 6 months).
Key exclusion criteria (5 listed)
- Subject has clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological or psychiatric disorder(s) as determined by the PI or designee.
- Subject has any disorder that would interfere with the absorption, distribution, metabolism or excretion of drugs.
- Subject has any concurrent disease or condition that, in the opinion of the PI, would make the subject unsuitable for participation in the clinical study.
- Subject has history of alcohol and/or illicit drug abuse within 2 years of Screening Visit.
- Subject has positive test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody or human immunodeficiency virus (HIV) antibody.
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 |
|---|---|---|
| CKD-508 CapsuleInvestigational drug | Drug | Part 1. CKD-508 Capsule in Single Dose |
| Placebo CapsulePlacebo | Drug | Part 1. Placebo Capsule in Single Dose |
| CKD-508 TabletInvestigational drug | Drug | Part 2. CKD-508 Tablet in Single Dose, Part 3. CKD-508 Tablet in Single Dose, Part 4. CKD-508 Tablet in Multiple Dose |
| Placebo TabletPlacebo | Drug | Part 2. Placebo Tablet in Single Dose, Part 3. Placebo Tablet in Single Dose, Part 4. Placebo Tablet in Multiple Dose |
Primary outcome
Safety and tolerability including treatment-emergent AE and treatment-emergent SAE
Time frame: 28 days post the final dose
5 secondary outcomes
Maximum plasma CKD-508 concentrations after dosing
Time frame: 28 days post the final dose
Time of maximum plasma CKD-508 concentrations after dosing
Time frame: 28 days post the final dose
Changes from baseline in plasma CKD-508 concentrations in time after dosing
Time frame: 28 days post the final dose
Changes from baseline in CETP activity after dosing
Time frame: 28 days post the final dose
Changes from baseline in lipid parameters after dosing
Time frame: 14 days post the final dose
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 15 Feb 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.
The record lists no contact. Use the official record to reach the sponsor.
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 CKD-508 Capsule and CKD-508 Tablet in people with Healthy Subjects, run by Chong Kun Dang Pharmaceutical at 1 site in United Kingdom.
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 5 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: finished, as of the sponsor's last update on 15 Feb 2024. 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 Kingdom. 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?
Safety and tolerability including treatment-emergent AE and treatment-emergent SAE (time frame: 28 days post the final dose). 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 15 Feb 2024.