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RO7223280 for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 19 months
Awards & highlights

Study Summary

This trial is testing a new drug, RO7223280, to see if it is safe and effective. The study has 3 parts. In the first part, healthy people will get a single dose of the drug to see how it affects them. In the second part, healthy people will get multiple doses of the drug to see how it affects them. The third part will test the drug in healthy elderly people.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 19 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 19 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Participants with Adverse Events (AEs)
Secondary outcome measures
Plasma Concentrations of RO7223280 at specified timepoints
Urine Concentrations of RO7223280 at specified timepoints

Trial Design

3Treatment groups
Experimental Treatment
Group I: Part 3 (Elderly)Experimental Treatment1 Intervention
In this cohort, a minimum of 4 participants and a maximum of 12 participants will receive a single IV dose of RO7223280 or placebo (3:1 ratio of active:placebo treatment).
Group II: Part 2 (MAD)Experimental Treatment1 Intervention
In each dose cohort, a minimum of 4 participants and a maximum of 12 participants will receive either multiple IV doses of RO72232809 or placebo once-daily for 10 days (3:1 ratio of active:placebo treatment).
Group III: Part 1 (SAD)Experimental Treatment1 Intervention
Due to mandatory sentinel dosing, participants will be divided into two groups: 2 participants will be dosed on one day (sentinel group with 1 on active treatment and 1 on placebo) and remaining participants of the dose cohort (randomized as 5 on active treatment and 1 on placebo) at the earliest 24 hours after the first dosing occasion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RO7223280
2020
Completed Phase 1
~180

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,088,930 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,199 Previous Clinical Trials
888,378 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What have the assessments disclosed regarding RO7223280's safety for patients?

"RO7223280 has yet to accumulate ample evidence of its safety and efficacy, therefore the score is 1 on a scale from 1-3."

Answered by AI

Does this trial still have open enrollment?

"Affirmative, the information available on clinicaltrials.gov confirms that this medical trial is actively recruiting patients. It was first posted on December 7th 2020 and its most recent update was November 16th 2022. The study aims to recruit 204 individuals from one single site."

Answered by AI

Is this research study open to seniors aged 75 and up?

"To meet trial enrollment requirements, patients must be between 18 and 64 years of age. There are additionally 50 studies for minors and 373 clinical trials targeting the elderly population."

Answered by AI

Do I meet the qualifications to participate in this trial?

"This clinical trial has a 204 person capacity and is searching for healthy subjects between the ages of 18-64 to fill their slots."

Answered by AI

How many participants are allowed to join this experiment?

"Affirmative, according to information found on clinicaltrials.gov this trial is still in search of participants. This study was initially posted at the start of December 2020 and recently modified on November 16th 2022. The target number of patients needed is 204 across one medical centre."

Answered by AI

Who else is applying?

What state do they live in?
Wisconsin
How old are they?
18 - 65
What site did they apply to?
Covance Clinical Research Unit, Inc
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Recent research and studies
clinicaltrials.govStudy
A Study To Investigate The Safety, Tolerability And Pharmacokinetics (PK) Of RO7223280 Following Intravenous Administration In Healthy Participants
2020. "A Study To Investigate The Safety, Tolerability And Pharmacokinetics (PK) Of RO7223280 Following Intravenous Administration In Healthy Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04605718.
~29 spots leftby Apr 2025
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