Clinical trial NCT04840745: The Safety and Pharmacokinetic/Pharmacodynamic Study of CKD-841 in Postmenopausal Female, Phase 1
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Early Puberty
Keywords: CKD-841
Postmenopausal
Leuplin
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
Collaborators: name: Severance Hospital
First posted: 2021-04-12
Enrollment: 32
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: PK(Cmax)
timeFrame: From before injection to up to 1008 hours post injection
measure: PK(AUClast)
timeFrame: From before injection to up to 1008 hours post injection
measure: PK(AUCinf)
timeFrame: From before injection to up to 1008 hours post injection
measure: PK(AUC7-t)
timeFrame: From before injection to up to 1008 hours post injection
measure: PK(CL/F)
timeFrame: From before injection to up to 1008 hours post injection
measure: PK(Vd/F)
timeFrame: From before injection to up to 1008 hours post injection
measure: PK(Tmax)
timeFrame: From before injection to up to 1008 hours post injection
measure: PK(t1/2)
timeFrame: From before injection to up to 1008 hours post injection
measure: PD(AUEC0-42d below baseline)
timeFrame: From before injection to up to 1008 hours post injection
measure: PD(AUEC0-28d below baseline)
timeFrame: From before injection to up to 1008 hours post injection
measure: PD(Area under the response (% change from baseline) curve)
timeFrame: From before injection to up to 1008 hours post injection
measure: PD(Tmax)
timeFrame: From before injection to up to 1008 hours post injection
measure: PD(Tmin)
timeFrame: From before injection to up to 1008 hours post injection
measure: PD(Emax)
timeFrame: From before injection to up to 1008 hours post injection
measure: PD(Emin)
timeFrame: From before injection to up to 1008 hours post injection
Secondary outcomes:
measure: Safety Assessment by evaluating adverse events(AEs).
timeFrame: From day1 to day 56
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
state: Yonsei-ro, Seodaemun-gu 50-1
Study officials:
affiliation: Severance Hospital
name: Min Soo Park, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: