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NCT05462522 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of RO7303509 in Participants With Systemic Sclerosis
A Phase 1 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
NCT05462522 is a Phase 1 study that has completed, run by Genentech. The registered enrollment target is 56 participants.
The verdict
NCT05462522, a Phase 1 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of RO7303509 treatment in participants with systemic sclerosis (SSc) during a multiple-ascending-dose (MAD) portion of the trial. In the MAD phase, increasing doses of study drug will be tested sequentially. For each dose tested, the MAD stage will consist of a treatment period of 12 weeks followed by either a safety follow-up period of 13 weeks or continued treatment in an optional open-label safety extension (OSE) stage of 52 weeks to assess the long-term safety. All patients in the OSE stage will receive RO7303509 and no patient will receive placebo.
Interventions
- DRUG Placebo
- DRUG RO7303509
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2023-01-16 |
| Est. Completion | 2025-07-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05462522
The ClinicalTrials.gov registry entry for NCT05462522 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05462522 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05462522 about?
NCT05462522 is a clinical study titled "A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of RO7303509 in Participants With Systemic Sclerosis". The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of RO7303509 treatment in participants with systemic sclerosis (SSc) during a multiple-ascending-dose (MAD) portion of the trial. In the MAD phase, increasing doses of study drug will be tested sequentially....
What is the current status of trial NCT05462522?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2023-01-16. Estimated completion is 2025-07-11.
What interventions are being tested in trial NCT05462522?
The interventions under investigation include: Placebo (DRUG), RO7303509 (DRUG).
Who is sponsoring clinical trial NCT05462522?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
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