Skip to content

A study to evaluate the safety of RO7303509 in healthy volunteers

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

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13175485
Enrollment
57
Registered
2020-08-20
Start date
2020-09-29
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammation Signs and Symptoms

Interventions

Current intervention as of 22/07/2022: Participants will be randomized to the treatment arms through an interactive voice or web-based response system (IxRS). In this single-ascending dose (SAD) study

Sponsors

Genentech, Inc.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
There are no secondary outcome measures

Countries

United States of America

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 8, 2026