Early PubertyPhase 1NCT04840745
The Safety and Pharmacokinetic/Pharmacodynamic Study of CKD-841 in Postmenopausal Female, Phase 1
A Phase 1 study testing CKD-841 A-1 3.75mg, CKD-841 A-1 1.88mg and CKD-841 D 2.92mg in people with Early Puberty, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
A randomized, single-blinded, parallel design phase I clinical trial to investigate the safety and pharmacokinetics/pharmacodynamics of CKD-841 A-1, CKD-841 D or Leuplin Inj. after subcutaneous injection in postmenopausal female Read more about this study
- Who is it for?
- Ages 40 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Early Puberty
- What is being tested?
- CKD-841 A-1 3.75mg, CKD-841 A-1 1.88mg and CKD-841 D 2.92mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2021to Nov 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 40 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy menopausal female
- β-hCG is negative at screening and before administration of investigational drug
- Infertility by sterilization operation before 5 months from screening excluding ovarian cancer, uterine cancer etc.
- Bwt ≥ 50Kg and Body Mass Index (BMI) ≥ 18.5 and < 28.0
Who cannot join
- History or current condition of disease related to Hepato-biliary system, renal system, nervous system, mental illness, immune system, respiratory system, endocrine system, hemato-oncology, circulatory system, musculoskeletal system or except for that, significant clinical disease
- Uncontrolled diabetes mellitus in the last three months
- Pregnancy or breast feeding
- History of taking medicine such as Leuprorelin acetate or similar affiliation drug within 12 weeks before administration of investigational drug
- Has hypersensitivity to the active ingredient or excipients or same affiliation drug of the investigational drug, hypersensitivity of a medicine contained gelatin especially
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Severance Hospital
Seoul, Yonsei-ro, Seodaemun-gu 50-1, 03722
About this study
Official title: A Randomized, Single-blinded, Parallel Design Phase I Clinical Trial to Investigate the Safety and Pharmacokinetics/Pharmacodynamics of CKD-841 A-1, CKD-841 D or Leuplin Inj. After Subcutaneous Injection in Postmenopausal Female
A randomized, single-blinded, parallel design phase I clinical trial to investigate the safety and pharmacokinetics/pharmacodynamics of CKD-841 A-1, CKD-841 D or Leuplin Inj. after subcutaneous injection in postmenopausal female
Read the detailed description
To investigate the safety and pharmacokinetics/pharmacodynamics of CKD-841 A-1, CKD-841 D or Leuplin Inj. 3.75 mg after subcutaneous injection in postmenopausal female
- Conditions
- Early Puberty
- Being tested
- CKD-841 A-1 3.75mg, CKD-841 A-1 1.88mg, CKD-841 D 2.92mg, Leuplin Inj. 3.75 mg
- Keywords
- CKD-841, Postmenopausal, Leuplin
- Medical subject headings
- Puberty, Precocious
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CKD-841 A-1 3.75mgDrug
Also called CKD-841
Single injection, subcutaneous injection
CKD-841 A-1 1.88mgDrug
Also called CKD-841
Single injection, subcutaneous injection
CKD-841 D 2.92mgDrug
Also called CKD-841
Single injection, subcutaneous injection
Leuplin Inj. 3.75 mgDrug
Also called Leuplin.Inj
Single injection, subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| CKD-841 A-1(=leuprorelin acetate 3.75mg) | Experimental | Investigational drug(=CKD-841 A-1) is prescribed single injection dose by subcutaneous to 8 of randomized subjects once. Receives: Drug: CKD-841 A-1 3.75mg |
| CKD-841 A-1(=leuprorelin acetate 1.88mg) | Experimental | Investigational drug(=CKD-841 A-1) is prescribed single injection dose by subcutaneous to 8 of randomized subjects once. Receives: Drug: CKD-841 A-1 1.88mg |
| CKD-841 D(=leuprorelin acetate 2.92mg) | Experimental | Investigational drug(=CKD-841 D) is prescribed single injection dose by subcutaneous to 8 of randomized subjects once. Receives: Drug: CKD-841 D 2.92mg |
| Leuplin Inj.(=leuprorelin acetate 3.75mg) | Active comparator | Investigational drug(=Leuplin Inj.)is prescribed single injection dose by subcutaneous to 8 of randomized subjects once. Receives: Drug: Leuplin Inj. 3.75 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK(Cmax)
Cmax(Maximum concentration of drug in plasma) of Leuprorelin
Measured: From before injection to up to 1008 hours post injection
PK(AUClast)
AUClast(Area under the plasma drug concentration-time curve to last measurement) of Leuprorelin
Measured: From before injection to up to 1008 hours post injection
PK(AUCinf)
AUCinf(Area under the plasma drug concentration-time curve extrapolated to infinity) of Leuprorelin
Measured: From before injection to up to 1008 hours post injection
PK(AUC7-t)
AUC7-t(Area under the plasma drug concentration-time curve from 7 days to last measurement) of Leuprorelin
Measured: From before injection to up to 1008 hours post injection
PK(CL/F)
CL/F(Apparent Clearance) of Leuprorelin
Measured: From before injection to up to 1008 hours post injection
PK(Vd/F)
Vd/F(Apparent Volume of Distribution) of Leuprorelin
Measured: From before injection to up to 1008 hours post injection
PK(Tmax)
Tmax(Time to Cmax/Time to Emax) of Leuprorelin
Measured: From before injection to up to 1008 hours post injection
PK(t1/2)
t1/2(Terminal elimination half-life) of Leuprorelin
Measured: From before injection to up to 1008 hours post injection
PD(AUEC0-42d below baseline)
AUEC0-42d below baseline((AUEC that is below the baseline from 0 h to 42 days)) of the rate of change(%) relative to the base of the LH (Luteinizing Hormone), FSH (Follicular Stimulating Hormone), and Estradiol respectively.
Measured: From before injection to up to 1008 hours post injection
PD(AUEC0-28d below baseline)
AUEC0-28d below baseline(AUEC that is below the baseline from 0 h to 28 days) of the rate of change(%) relative to the base of the LH (Luteinizing Hormone), FSH (Follicular Stimulating Hormone), and Estradiol respectively.
Measured: From before injection to up to 1008 hours post injection
PD(Area under the response (% change from baseline) curve)
AUEC(Area under the response (% change from baseline) curve) above baseline of the rate of change(%) relative to the base of the LH (Luteinizing Hormone), FSH (Follicular Stimulating Hormone), and Estradiol respectively.
Measured: From before injection to up to 1008 hours post injection
PD(Tmax)
Tmax(Time to Cmax/Time to Emax) of the rate of change(%) relative to the base of the LH (Luteinizing Hormone), FSH (Follicular Stimulating Hormone), and Estradiol respectively.
Measured: From before injection to up to 1008 hours post injection
PD(Tmin)
Tmin(Time to Emin) of the rate of change(%) relative to the base of the LH (Luteinizing Hormone), FSH (Follicular Stimulating Hormone), and Estradiol respectively.
Measured: From before injection to up to 1008 hours post injection
PD(Emax)
Emax(Maximum % change from baseline of LH/FSH/Estradiol) of the rate of change(%) relative to the base of the LH (Luteinizing Hormone), FSH (Follicular Stimulating Hormone), and Estradiol respectively.
Measured: From before injection to up to 1008 hours post injection
PD(Emin)
Emin(Minimum % change from baseline of LH/FSH/Estradiol) of the rate of change(%) relative to the base of the LH (Luteinizing Hormone), FSH (Follicular Stimulating Hormone), and Estradiol respectively.
Measured: From before injection to up to 1008 hours post injection
Secondary outcomes (1)
Safety Assessment by evaluating adverse events(AEs).
Assessment of the safety of subjects by evaluating adverse events(AEs).
Measured: From day1 to day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study startApr 2021 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early PubertyStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Severance Hospital
- Responsible party
- Sponsor
- Investigators
- Min Soo Park, Ph.D, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04840745
- Sponsor's protocol ID
- A55_03PK2023
- Status last verified
- Apr 2021
- First submitted
- 8 Apr 2021
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-blinded, Parallel Design Phase I Clinical Trial to Investigate the Safety and Pharmacokinetics/Pharmacodynamics of CKD-841 A-1, CKD-841 D or Leuplin Inj. After Subcutaneous Injection in Postmenopausal Female
- ClinicalTrials.gov ID
- NCT04840745
- Acronym / sponsor ID
- A55_03PK2023
- Conditions
- Early Puberty
- Keywords
- CKD-841, Postmenopausal, Leuplin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Collaborators
- Severance Hospital
- Study start
- Apr 2021 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 12 Apr 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.
A randomized, single-blinded, parallel design phase I clinical trial to investigate the safety and pharmacokinetics/pharmacodynamics of CKD-841 A-1, CKD-841 D or Leuplin Inj. after subcutaneous injection in postmenopausal female
Detailed description
To investigate the safety and pharmacokinetics/pharmacodynamics of CKD-841 A-1, CKD-841 D or Leuplin Inj. 3.75 mg after subcutaneous injection in postmenopausal female
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CKD-841 A-1(=leuprorelin acetate 3.75mg) | Experimental | Drug: CKD-841 A-1 3.75mgInvestigational drug(=CKD-841 A-1) is prescribed single injection dose by subcutaneous to 8 of randomized subjects once. |
| CKD-841 A-1(=leuprorelin acetate 1.88mg) | Experimental | Drug: CKD-841 A-1 1.88mgInvestigational drug(=CKD-841 A-1) is prescribed single injection dose by subcutaneous to 8 of randomized subjects once. |
| CKD-841 D(=leuprorelin acetate 2.92mg) | Experimental | Drug: CKD-841 D 2.92mgInvestigational drug(=CKD-841 D) is prescribed single injection dose by subcutaneous to 8 of randomized subjects once. |
| Leuplin Inj.(=leuprorelin acetate 3.75mg) | Active comparator | Drug: Leuplin Inj. 3.75 mgInvestigational drug(=Leuplin Inj.)is prescribed single injection dose by subcutaneous to 8 of randomized subjects once. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy menopausal female
- β-hCG is negative at screening and before administration of investigational drug
- Infertility by sterilization operation before 5 months from screening excluding ovarian cancer, uterine cancer etc.
- Bwt ≥ 50Kg and Body Mass Index (BMI) ≥ 18.5 and < 28.0
Key exclusion criteria (5 listed)
- History or current condition of disease related to Hepato-biliary system, renal system, nervous system, mental illness, immune system, respiratory system, endocrine system, hemato-oncology, circulatory system, musculoskeletal system or except for that, significant clinical disease
- Uncontrolled diabetes mellitus in the last three months
- Pregnancy or breast feeding
- History of taking medicine such as Leuprorelin acetate or similar affiliation drug within 12 weeks before administration of investigational drug
- Has hypersensitivity to the active ingredient or excipients or same affiliation drug of the investigational drug, hypersensitivity of a medicine contained gelatin especially
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-841 A-1 3.75mgAlso: CKD-841Single injection, subcutaneous injection | Drug | CKD-841 A-1(=leuprorelin acetate 3.75mg) |
| CKD-841 A-1 1.88mgAlso: CKD-841Single injection, subcutaneous injection | Drug | CKD-841 A-1(=leuprorelin acetate 1.88mg) |
| CKD-841 D 2.92mgAlso: CKD-841Single injection, subcutaneous injection | Drug | CKD-841 D(=leuprorelin acetate 2.92mg) |
| Leuplin Inj. 3.75 mgAlso: Leuplin.InjSingle injection, subcutaneous injection | Drug | Leuplin Inj.(=leuprorelin acetate 3.75mg) |
Primary outcome
PK(Cmax)
Time frame: From before injection to up to 1008 hours post injection
Cmax(Maximum concentration of drug in plasma) of Leuprorelin
PK(AUClast)
Time frame: From before injection to up to 1008 hours post injection
AUClast(Area under the plasma drug concentration-time curve to last measurement) of Leuprorelin
PK(AUCinf)
Time frame: From before injection to up to 1008 hours post injection
AUCinf(Area under the plasma drug concentration-time curve extrapolated to infinity) of Leuprorelin
PK(AUC7-t)
Time frame: From before injection to up to 1008 hours post injection
AUC7-t(Area under the plasma drug concentration-time curve from 7 days to last measurement) of Leuprorelin
PK(CL/F)
Time frame: From before injection to up to 1008 hours post injection
CL/F(Apparent Clearance) of Leuprorelin
PK(Vd/F)
Time frame: From before injection to up to 1008 hours post injection
Vd/F(Apparent Volume of Distribution) of Leuprorelin
PK(Tmax)
Time frame: From before injection to up to 1008 hours post injection
Tmax(Time to Cmax/Time to Emax) of Leuprorelin
PK(t1/2)
Time frame: From before injection to up to 1008 hours post injection
t1/2(Terminal elimination half-life) of Leuprorelin
PD(AUEC0-42d below baseline)
Time frame: From before injection to up to 1008 hours post injection
AUEC0-42d below baseline((AUEC that is below the baseline from 0 h to 42 days)) of the rate of change(%) relative to the base of the LH (Luteinizing Hormone), FSH (Follicular Stimulating Hormone), and Estradiol respectively.
PD(AUEC0-28d below baseline)
Time frame: From before injection to up to 1008 hours post injection
AUEC0-28d below baseline(AUEC that is below the baseline from 0 h to 28 days) of the rate of change(%) relative to the base of the LH (Luteinizing Hormone), FSH (Follicular Stimulating Hormone), and Estradiol respectively.
PD(Area under the response (% change from baseline) curve)
Time frame: From before injection to up to 1008 hours post injection
AUEC(Area under the response (% change from baseline) curve) above baseline of the rate of change(%) relative to the base of the LH (Luteinizing Hormone), FSH (Follicular Stimulating Hormone), and Estradiol respectively.
PD(Tmax)
Time frame: From before injection to up to 1008 hours post injection
Tmax(Time to Cmax/Time to Emax) of the rate of change(%) relative to the base of the LH (Luteinizing Hormone), FSH (Follicular Stimulating Hormone), and Estradiol respectively.
PD(Tmin)
Time frame: From before injection to up to 1008 hours post injection
Tmin(Time to Emin) of the rate of change(%) relative to the base of the LH (Luteinizing Hormone), FSH (Follicular Stimulating Hormone), and Estradiol respectively.
PD(Emax)
Time frame: From before injection to up to 1008 hours post injection
Emax(Maximum % change from baseline of LH/FSH/Estradiol) of the rate of change(%) relative to the base of the LH (Luteinizing Hormone), FSH (Follicular Stimulating Hormone), and Estradiol respectively.
PD(Emin)
Time frame: From before injection to up to 1008 hours post injection
Emin(Minimum % change from baseline of LH/FSH/Estradiol) of the rate of change(%) relative to the base of the LH (Luteinizing Hormone), FSH (Follicular Stimulating Hormone), and Estradiol respectively.
1 secondary outcome
Safety Assessment by evaluating adverse events(AEs).
Time frame: From day1 to day 56
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Individual participant dataSharing planned: No
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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.
Min Soo Park, Ph.D principal investigator
Severance Hospital
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-841 A-1 3.75mg, CKD-841 A-1 1.88mg and CKD-841 D 2.92mg in people with Early Puberty, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
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: status not confirmed, as of the sponsor's last update on 19 Apr 2021. 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 South Korea. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Soo Park, Ph.D (82-2-2228-0401, minspark@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PK(Cmax) (time frame: From before injection to up to 1008 hours post injection). The study lists 15 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 19 Apr 2021.