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

NCT04840745 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2021-04-19

No results posted yet for this study

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

Conditions

  • Early Puberty

Interventions

DRUG

CKD-841 A-1 3.75mg

Single injection, subcutaneous injection

DRUG

CKD-841 A-1 1.88mg

Single injection, subcutaneous injection

DRUG

CKD-841 D 2.92mg

Single injection, subcutaneous injection

DRUG

Leuplin Inj. 3.75 mg

Single injection, subcutaneous injection

Sponsors & Collaborators

  • Severance Hospital

    collaborator OTHER

  • Chong Kun Dang Pharmaceutical

    lead INDUSTRY

Principal Investigators

  • Min Soo Park, Ph.D · Severance Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-30
Primary Completion
2021-10-31
Completion
2021-11-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04840745 on ClinicalTrials.gov