臨床研究等提出・公開システム

Date of registration	Jan. 15, 2018
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080223775

Scientific Title	A Phase I Single-Dose Study of RO7046015 in Healthy Japanese Men
Public Title	A Phase I Single-Dose Study of RO7046015 in Healthy Japanese Men

Completion Date or Terminated date
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	Chugai Pharmaceutical Co., Ltd.
	Address	clinical-trials@chugai-pharm.co.jp
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	Chugai Pharmaceutical Co., Ltd.
	Address	clinical-trials@chugai-pharm.co.jp
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		24
Study Type		Interventional
Study Design	Study Design	placebo-controlled, randomized, double-blind, dose-escalation study
Study Design	Objective
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	1. Healthy Japanese man who is 21 to 65 years of age at the time of informed consent. 2. Body weight of >45 kg and <=110 kg at screening. Body mass index (weight [kg]/[height {m}]2) of 18 to <=32 kg/m2 at screening. 3. Consent by partner of childbearing potential to use a contraceptive method (hormonal contraceptives, intrauterine device, barrier method [excluding rhythm method], etc.) from 30 days before administration of the IMP until 174 days after administration. 4. Written informed consent.
	Exclusion Criteria	1. Clinically significant illness or clinically significant surgery within 4 weeks before starting administration of the IMP. 2. Participation in a clinical study and treatment with an IMP (including placebo) within 4 months (or 5 half-lives of the other IMP, whichever is longer) before enrollment. 3. Vaccination with a live or inactivated vaccine within 30 days before enrollment, or anticipated vaccination with a live or inactivated vaccine during the study period. 4. Use of systemic corticosteroids or other immunomodulators within 30 days before enrollment. 5. Use of prescription drugs within 14 days before enrollment. However, subjects will be permitted to use products that do not result in systemic exposure and would therefore have no effect even if they were used, such as topical antiseptics and eye-drops.
	Minimum Age	21age old over
	Maximum Age	65age old under
	Gender	Male
Health Condition or Problem Studied		Healthy adults
Intervention(s)		investigational material(s) Generic name etc : RO7046015 INN of investigational material : prasinezumab Therapeutic category code : 116 Antiperkinsonism agents Dosage and Administration for Investigational material : intravenous
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		safety, tolerability
Secondary Outcome		pharmacokinetics

Primary Sponsor	CHUGAI PHARMACEUTICAL CO., LTD.
Secondary Sponsor	Roche/Prothena

Name of Funding Organization
Name of Research Funding

Name of IRB
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-183831
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
9	Dec. 17, 2018	(this page)	Changes
8	Aug. 27, 2018	Detail	Changes
7	Aug. 27, 2018	Detail	Changes
6	April. 18, 2018	Detail	Changes
5	April. 18, 2018	Detail	Changes
4	Feb. 20, 2018	Detail	Changes
3	Feb. 20, 2018	Detail	Changes
2	Jan. 15, 2018	Detail	Changes
1	Jan. 15, 2018	Detail

List of change history