NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JAPIC ID: JapicCTI-183831

Registered date:

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

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedHealthy adults
Date of first enrollment01/1/2018
Target sample size24
Countries of recruitment
Study typeINTERVENTIONAL
Intervention(s)Intervention name : RO7046015 INN of the intervention : prasinezumab Dosage And administration of the intervention : intravenous Control intervention name : null

Outcome(s)

Primary Outcomesafety, tolerability
Secondary Outcomepharmacokinetics

Key inclusion & exclusion criteria

Age minimum21
Age maximum65
GenderMale
Include criteria1. 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.
Exclude criteria1. 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.

Related Information

Contact

public contact
Name Chugai Pharmaceutical Co., Ltd. Clinical trials information
Address clinical-trials@chugai-pharm.co.jp
Telephone
E-mail
Affiliation
scientific contact
Name Chugai Pharmaceutical Co., Ltd. Clinical trials information
Address clinical-trials@chugai-pharm.co.jp
Telephone
E-mail
Affiliation