The Safety and Pharmacokinetic/Pharmacodynamic Study of CKD-841 in Postmenopausal Female, Phase 1

Chong Kun Dang

Status and phase: Unknown; Phase 1

Conditions: Early Puberty

Treatments: Drug: Leuplin Inj. 3.75 mg; Drug: CKD-841 D 2.92mg; Drug: CKD-841 A-1 3.75mg; Drug: CKD-841 A-1 1.88mg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04840745

A55_03PK2023

Details and patient eligibility

About

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

Full 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

Enrollment: 32 estimated patients

Sex: Female

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 4 patient groups

CKD-841 A-1(=leuprorelin acetate 3.75mg)

Experimental group

Description:

Investigational drug(=CKD-841 A-1) is prescribed single injection dose by subcutaneous to 8 of randomized subjects once.

Treatment:

Drug: CKD-841 A-1 3.75mg

CKD-841 A-1(=leuprorelin acetate 1.88mg)

Experimental group

Description:

Investigational drug(=CKD-841 A-1) is prescribed single injection dose by subcutaneous to 8 of randomized subjects once.

Treatment:

Drug: CKD-841 A-1 1.88mg

CKD-841 D(=leuprorelin acetate 2.92mg)

Experimental group

Description:

Investigational drug(=CKD-841 D) is prescribed single injection dose by subcutaneous to 8 of randomized subjects once.

Treatment:

Drug: CKD-841 D 2.92mg

Leuplin Inj.(=leuprorelin acetate 3.75mg)

Active Comparator group

Description:

Investigational drug(=Leuplin Inj.)is prescribed single injection dose by subcutaneous to 8 of randomized subjects once.

Treatment:

Drug: Leuplin Inj. 3.75 mg