Healthy VolunteersPhase 1NCT04746287
Evaluation of the Safety and Tolerability of CKD-510 in Healthy Subjects
A Phase 1 study testing CKD-510 single dose, CKD-510 food effect and CKD-510 multiple dose in people with Healthy Volunteers, run by Chong Kun Dang Pharmaceutical at 1 site in France.
Trial summary
This is a first-in-human study of CKD-510 in single-ascending dose and multiple-ascending dose in healthy subjects. This trial is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics of food effects of CKD-510. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- CKD-510 single dose, CKD-510 food effect and CKD-510 multiple dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 1 siteFrance
- Study dates
- 14 Jan 2020to 24 Aug 2021
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subject
- Non-smoker subject or light smoker
- Body mass index (BMI) between 18 and 30 kg/m2 inclusive at screening
- Laboratory parameters within the normal range of the laboratory.
- Male volunteers must be either vasectomized or agree to use a condom during the course of the study and until 3 months (90 days) after the participant's last visit
- Signing a written informed consent prior to selection
Who cannot join
- Any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic or infectious disease
- Blood donation within 2 months before administration
- General anesthesia within 3 months before administration
- Presence or history of drug hypersensitivity, or allergic disease
- Any drug intake (except paracetamol or contraception) during the 28 days prior to the first administration
- History or presence of alcohol or drug abuse
- Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development
- Use of an investigational drug within 3 months (or 90 days) prior to Day1
Trial locations and contacts
1 site in 1 country.
About this study
Official title: First-in-Human, Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effects of CKD-510 in Single Ascending Dose and Multiple Ascending Dose in Healthy Subjects
This is a first-in-human study of CKD-510 in single-ascending dose and multiple-ascending dose in healthy subjects. This trial is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics of food effects of CKD-510.
- Conditions
- Healthy Volunteers
- Being tested
- CKD-510 single dose, CKD-510 food effect, CKD-510 multiple dose, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD-510 single doseDrug
Investigational drug
CKD-510 food effectDrug
Investigational drug
CKD-510 multiple doseDrug
Investigational drug
PlaceboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | Single dose administration Receives: Drug: CKD-510 single dose |
| Part B | Experimental | Multiple dose administration (food Effect) Receives: Drug: CKD-510 food effect |
| Part C | Experimental | Multiple dose administration Receives: Drug: CKD-510 multiple dose |
| Placebo | Placebo comparator | Matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
[Part A, Part C] Number of subjects with adverse events (AEs)
The relationship of each adverse event to the investigational product was assessed by the investigator.
Measured: Treatment duration up to 4 days
[Part A, Part C] Safety as assessed by vital signs
Symptoms of vital signs will be assessed.
Measured: Treatment duration up to 4 days
[Part A, Part C] Safety as assessed by abbreviated physical examination parameters
Physical exmaination will include evaluation of main body systems/regions
Measured: Treatment duration up to 4 days
[Part A, Part C] Safety as assessed by electrocardiogram (ECG) parameters
12-lead ECGs will be obtained during the study using an ECG machine
Measured: Treatment duration up to 4 days
[Part A, Part C] Safety as assessed by biological analysis
Biological test will be obtained with assessments including hematology, biochemistry, urinalysis.
Measured: Treatment duration up to 4 days
[Part B] Composite of pharmacokinetics (PK) assessments of CKD-510
PK parameters include plasma concentrations of CKD-510, maximum observed plasma concentration (Cmax), time to Cmax (tmax), area under the plasma concentration-time curve (AUC) to last measurable concentration [AUC(0-t)], AUC through 24 hours [AUC(0-24)] and AUC per dosing interval [AUC(0-tau)], apparent terminal phase half-life following the last dose (t1/2) in fast or fed conditions.
Measured: 3 days post dose
[Part B] Composite of pharmacodynamics (PD) assessments of CKD-510
Change from baseline in acetylation of alpha-tubulin and histone as pharmacodynamics assessments after an administration of CKD-510 in fast or fed conditions
Measured: 3 days post dose
Secondary outcomes (12)
[Part A, Part C] Maximum plasma concentration of CKD-510
Peak plasma concentration (Cmax)
Measured: 4 days post dose (SAD) or 17 days post dose (MAD)
[Part A, Part C] Time of maximum plasma concentration of CKD-510
Time to reach Cmax (Tmax)
Measured: 4 days post dose (SAD) or 17 days post dose (MAD)
[Part A, Part C] Changes from baseline in plasma concentrations CKD-510 in time after dosing
Area under the concentration-time curve from time 0 extrapolated to the last quantifiable concentration at time t (AUC0-t)
Measured: 4 days post dose (SAD) or 17 days post dose (MAD)
[Part A, Part C] Time of plasma elimination half-life of CKD-510
Apparent terminal elimination half-life (t½)
Measured: 4 days post dose (SAD) or 17 days post dose (MAD)
[Part A, Part C] Volume of distribution of CKD-510
Apparent volume of distribution during the terminal elimination phase (Vd/F)
Measured: 4 days post dose (SAD) or 17 days post dose (MAD)
[Part A, Part C] Total plasma clearance of CKD-510
Apparent total plasma clearance (CL/F)
Measured: 4 days post dose (SAD) or 17 days post dose (MAD)
[Part A, Part C] Pharmacodynamics assessments of CKD-510
Change from baseline in acetylation of alpha-tubulin and histone
Measured: up to 2 days post dose (SAD) or 17 days post dose (MAD)
[Part B] Number of subjects with adverse events (AEs)
The relationship of each adverse event to the investigational product was assessed by the investigator
Measured: 3 days post dose
[Part B] Safety as assessed by vital signs
Symptoms of vital signs will be assessed.
Measured: 3 days post dose
[Part B] Safety as assessed by abbreviated physical examination parameters
Physical exmaination will include evaluation of main body systems/regions
Measured: 3 days post dose
[Part B] Safety as assessed by electrocardiogram (ECG) parameters
12-lead ECGs will be obtained during the study using an ECG machine
Measured: 3 days post dose
[Part B] Safety as assessed by biological analysis
Biological test will be obtained with assessments including hematology, biochemistry, urinalysis.
Measured: 3 days post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start14 Jan 2020
- Primary completion24 Aug 2021
- Study completion24 Aug 2021
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 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
- Model description
- Drug: CKD-510 Drug: Placebo
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 87 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
- NCT04746287
- Sponsor's protocol ID
- A96_01CMT1914
- Status last verified
- May 2022
- First submitted
- 15 Jan 2021
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First-in-Human, Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effects of CKD-510 in Single Ascending Dose and Multiple Ascending Dose in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04746287
- Acronym / sponsor ID
- A96_01CMT1914
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 14 Jan 2020 (actual)
- Primary completion
- 24 Aug 2021 (actual)
- Study completion
- 24 Aug 2021 (actual)
- First posted
- 9 Feb 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 first-in-human study of CKD-510 in single-ascending dose and multiple-ascending dose in healthy subjects. This trial is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics of food effects of CKD-510.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Drug: CKD-510 Drug: Placebo
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: CKD-510 single doseSingle dose administration |
| Part B | Experimental | Drug: CKD-510 food effectMultiple dose administration (food Effect) |
| Part C | Experimental | Drug: CKD-510 multiple doseMultiple dose administration |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy male subject
- Non-smoker subject or light smoker
- Body mass index (BMI) between 18 and 30 kg/m2 inclusive at screening
- Laboratory parameters within the normal range of the laboratory.
- Male volunteers must be either vasectomized or agree to use a condom during the course of the study and until 3 months (90 days) after the participant's last visit
Key exclusion criteria (8 listed)
- Any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic or infectious disease
- Blood donation within 2 months before administration
- General anesthesia within 3 months before administration
- Presence or history of drug hypersensitivity, or allergic disease
- Any drug intake (except paracetamol or contraception) during the 28 days prior to the first administration
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-510 single doseInvestigational drug | Drug | Part A |
| CKD-510 food effectInvestigational drug | Drug | Part B |
| CKD-510 multiple doseInvestigational drug | Drug | Part C |
| PlaceboMatching placebo | Drug | Placebo |
Primary outcome
[Part A, Part C] Number of subjects with adverse events (AEs)
Time frame: Treatment duration up to 4 days
The relationship of each adverse event to the investigational product was assessed by the investigator.
[Part A, Part C] Safety as assessed by vital signs
Time frame: Treatment duration up to 4 days
Symptoms of vital signs will be assessed.
[Part A, Part C] Safety as assessed by abbreviated physical examination parameters
Time frame: Treatment duration up to 4 days
Physical exmaination will include evaluation of main body systems/regions
[Part A, Part C] Safety as assessed by electrocardiogram (ECG) parameters
Time frame: Treatment duration up to 4 days
12-lead ECGs will be obtained during the study using an ECG machine
[Part A, Part C] Safety as assessed by biological analysis
Time frame: Treatment duration up to 4 days
Biological test will be obtained with assessments including hematology, biochemistry, urinalysis.
[Part B] Composite of pharmacokinetics (PK) assessments of CKD-510
Time frame: 3 days post dose
PK parameters include plasma concentrations of CKD-510, maximum observed plasma concentration (Cmax), time to Cmax (tmax), area under the plasma concentration-time curve (AUC) to last measurable concentration [AUC(0-t)], AUC through 24 hours [AUC(0-24)] and AUC per dosing interval [AUC(0-tau)], apparent terminal phase half-life following the last dose (t1/2) in fast or fed conditions.
[Part B] Composite of pharmacodynamics (PD) assessments of CKD-510
Time frame: 3 days post dose
Change from baseline in acetylation of alpha-tubulin and histone as pharmacodynamics assessments after an administration of CKD-510 in fast or fed conditions
12 secondary outcomes
[Part A, Part C] Maximum plasma concentration of CKD-510
Time frame: 4 days post dose (SAD) or 17 days post dose (MAD)
[Part A, Part C] Time of maximum plasma concentration of CKD-510
Time frame: 4 days post dose (SAD) or 17 days post dose (MAD)
[Part A, Part C] Changes from baseline in plasma concentrations CKD-510 in time after dosing
Time frame: 4 days post dose (SAD) or 17 days post dose (MAD)
[Part A, Part C] Time of plasma elimination half-life of CKD-510
Time frame: 4 days post dose (SAD) or 17 days post dose (MAD)
[Part A, Part C] Volume of distribution of CKD-510
Time frame: 4 days post dose (SAD) or 17 days post dose (MAD)
[Part A, Part C] Total plasma clearance of CKD-510
Time frame: 4 days post dose (SAD) or 17 days post dose (MAD)
[Part A, Part C] Pharmacodynamics assessments of CKD-510
Time frame: up to 2 days post dose (SAD) or 17 days post dose (MAD)
[Part B] Number of subjects with adverse events (AEs)
Time frame: 3 days post dose
[Part B] Safety as assessed by vital signs
Time frame: 3 days post dose
[Part B] Safety as assessed by abbreviated physical examination parameters
Time frame: 3 days post dose
[Part B] Safety as assessed by electrocardiogram (ECG) parameters
Time frame: 3 days post dose
[Part B] Safety as assessed by biological analysis
Time frame: 3 days post 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 4 May 2022.
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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-510 single dose, CKD-510 food effect and CKD-510 multiple dose in people with Healthy Volunteers, run by Chong Kun Dang Pharmaceutical at 1 site in France.
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 6 inclusion and 8 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 4 May 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 France. 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?
[Part A, Part C] Number of subjects with adverse events (AEs) (time frame: Treatment duration up to 4 days). The study lists 7 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 4 May 2022.