ISRCTN13175485
Completed
Phase 1
A Phase Ia, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of single-ascending doses of RO7303509 in healthy volunteers
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Inflammation
- Sponsor
- Genentech, Inc.
- Enrollment
- 57
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
2024 Results article in https://pubmed.ncbi.nlm.nih.gov/38662148/ (added 26/04/2024)
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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