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

Phase 1

• Conditions: Healthy adults

• Registration Number: JPRN-jRCT2080223775
• Lead Sponsor: CHUGAI PHARMACEUTICAL CO., LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-15
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: Male
• Target Recruitment: 24

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified