臨床研究等提出・公開システム

Date of registration	July. 29, 2019
Last modified on	July. 31, 2019
Trial ID	jRCT2080224808

Scientific Title	Phase 1 trial of adrenomedullin; Single-dose administration study
Public Title	Single-dose administration study of adrenomedullin

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	University of Miyazaki
	Address	5200 Kihara, Kiyotake, Miyazaki, JAPAN
	Phone Number	+81-985-85-0872
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	University of Miyazaki
	Address	5200 Kihara, Kiyotake, Miyazaki, JAPAN
	Phone Number	+81-985-85-0872
	E-mail Address

Recruitment Status	completed

Date of First Enrolment		Nov. 12, 2015
Target Sample Size		24
Study Type		Interventional
Study Design	Study Design	randomized, double-blind, single-center, dose-escalation study
Study Design	Objective	treatment purpose
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	healthy male
	Exclusion Criteria	history of malignancy and/or myocardial infarction systolic blood pressure under 100 mmHg pulse rate under 45 bpm body weight over 90 kg
	Minimum Age	20age old over
	Maximum Age	65age old under
	Gender	Male
Health Condition or Problem Studied		healthy
Intervention(s)		investigational material(s) Generic name etc : adrenomedullin INN of investigational material : adrenomedullin Therapeutic category code : 249 Other hormone preparations (including antihormone preparations) Dosage and Administration for Investigational material : continuous intravenous infusion for 12 hours control material(s) Generic name etc : placebo INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational material : continuous intravenous infusion for 12 hours
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		safety Safety and tolerability
Secondary Outcome		pharmacokinetics pharmacokinetics

Primary Sponsor	University of Miyazaki
Secondary Sponsor	Souseikai Hakata Clinic

Name of Funding Organization	Japan Agency for Medical Research and Development
Name of Research Funding	Practical Research Project for Rare/Intractable Diseases

Name of IRB	Institutional Review Board of University of Miyazaki
Address of IRB	5200 Kihara, Kiyotake, Miyazaki, JAPAN
Phone Number of IRB	+81-985-85-9852
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	May. 28, 2015

Secondary ID No.	JapicCTI-194891
Name of Other Registries

Countries / Regions of Recruitment	Japan