A study to evaluate the safety, tolerability and processing by the body of RO7440688 in healthy volunteers

Phase 1

Completed

• Conditions: Cardiovascular disease; Circulatory System

• Registration Number: ISRCTN15492429
• Lead Sponsor: Genentech, Inc

Brief Summary

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37350225/ (added 08/04/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-10
• Study Completion: 2022-03-21
• Last Update Posted: 22 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

1. Age =18 years and =65 years
2. Ability to comply with the study protocol, in the investigator’s judgment
3. Use of contraceptive measures

Exclusion Criteria

Current participant exclusion criteria as of 05/11/2021:
1. Pregnant or breastfeeding, or intending to become pregnant during the study or within 14 days of last study drug dose for subjects in the SAD and food effect stages and 28 days for subjects in the MAD and DDI stages
2. No comorbid conditions that may interfere with the evaluation of an investigational medical product
3. No history or evidence of substance abuse that would pose a risk to participants safety, interfere with the conduct of the study, or have an impact on the study results
4. History of severe allergic or anaphylactic reactions to human, humanized, or Current treatment with medications that are well known to prolong the QT

Previous participant exclusion criteria:
1. Pregnant or breastfeeding, or intending to become pregnant during the study or within 14 days of last study drug dose for subjects in the SAD and food effect stages and 28 days for subjects in the MAD stage
2. No comorbid conditions that may interfere with the evaluation of an investigational medical product
3. No history or evidence of substance abuse that would pose a risk to participants safety, interfere with the conduct of the study, or have an impact on the study results
4. History of severe allergic or anaphylactic reactions to human, humanized, or Current treatment with medications that are well known to prolong the QT

Study & Design

• Study Type: Interventional
• Study Design: Not specified