A study to evaluate the safety of RO7303509 in healthy volunteers

Phase 1

Completed

• Conditions: Inflammation; Signs and Symptoms

• Registration Number: ISRCTN13175485
• Lead Sponsor: Genentech, Inc.

Brief Summary

2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38662148/ (added 26/04/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-20
• Study Completion: 2022-05-19
• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

1. Age =18 years and =75 years
2. Ability to comply with the study protocol, in the investigator’s judgment
3. Use of contraceptive measures

Exclusion Criteria

1. Pregnant or breastfeeding, or intending to become pregnant during the study or within 85 days after the dose of RO7303509
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

Primary Outcome Measures

Name	Time	Method
The safety of single doses of RO7303509 according to the World Health Organization (WHO) Toxicity Grading Scale and vital signs, labs and ECG from baseline to day 85

Secondary Outcome Measures

Name	Time	Method
There are no secondary outcome measures