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Part 2: Cohort 1 VRG50635 for Healthy Subjects

Phase 1
Recruiting
Research Sponsored by Verge Genomics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have a body mass index ≥ 18.5 and ≤ 32 kg/m2 and weigh ≥ 50 kg
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 30
Awards & highlights

Study Summary

"This trial aims to see if VRG50635 is safe for use and how well the body absorbs it."

Who is the study for?
This clinical trial is for healthy individuals who want to participate in a study testing the safety of a new medication. Specific eligibility criteria are not provided, but typically participants should be free from any significant health issues.Check my eligibility
What is being tested?
The trial is examining VRG50635, which is being compared to a placebo (a substance with no active drug). The goal is to see how safe VRG50635 is and how it's processed by the body when taken.See study design
What are the potential side effects?
Since this trial involves healthy volunteers and tests a new drug, potential side effects are unknown. Commonly, such trials look out for any adverse reactions ranging from mild symptoms like headaches or nausea to more serious ones.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My BMI is between 18.5 and 32, and I weigh at least 50 kg.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 30
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 30 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Concentration-time Curve Between Consecutive Doses (AUCtau)
Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUCinf)
Area Under the Concentration-time Curve from Time 0 to 24 Hours Post-dose (AUC0-24)
+5 more

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 2: Cohort 2 VRG50635Experimental Treatment1 Intervention
Participants will receive VRG50635 (Dose Y) for 14 consecutive days.
Group II: Part 2: Cohort 1 VRG50635Experimental Treatment1 Intervention
Participants will receive VRG50635 (Dose X) for 14 consecutive days.
Group III: Part 1: VRG50635 Sequence B, A, CExperimental Treatment1 Intervention
Participants will receive a single dose of VRG50635 in each of 3 treatment periods separated by 14-day washout periods.
Group IV: Part 1: VRG50635 Sequence A, B, CExperimental Treatment1 Intervention
Participants will receive a single dose of VRG50635 in each of 3 treatment periods separated by 14-day washout periods.
Group V: Part 2: Cohort 2 PlaceboPlacebo Group1 Intervention
Participants will receive VRG50635-matching placebo for 14 consecutive days.
Group VI: Part 2: Cohort 1 PlaceboPlacebo Group1 Intervention
Participants will receive VRG50635-matching placebo for 14 consecutive days.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Verge GenomicsLead Sponsor
1 Previous Clinical Trials
50 Total Patients Enrolled

Frequently Asked Questions

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

Do I meet the necessary criteria to participate in this clinical investigation?

"To be eligible for this clinical investigation, participants must be in good health and aged between 19 to 55 years. The trial aims to enroll approximately 30 individuals."

Answered by AI

Are there ongoing efforts to actively enroll participants for this medical study?

"As per clinicaltrials.gov, the current trial is not in active recruitment. It was initially listed on 2/28/2024 and last revised on 2/22/2024. While this specific study does not currently seek participants, there are a substantial number of 796 other ongoing trials that are enrolling individuals at this moment."

Answered by AI

Is the recruitment for this clinical trial restricted to individuals younger than 55 years old?

"Eligible candidates for this research endeavor are individuals aged between 19 and 55 years. Notably, there are 67 trials tailored for those under 18, along with an additional 375 aimed towards participants over the age of 65."

Answered by AI

Is the FDA in agreement with Part 1: VRG50635 Sequence B, A, C?

"Based on the Phase 1 nature of this trial with limited safety and efficacy data, our team at Power rates Part 1: VRG50635 Sequence B, A, C as a level 1 in terms of safety."

Answered by AI

Who else is applying?

What site did they apply to?
Site 001
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study of VRG50635 in Healthy Volunteers
2024. "A Study of VRG50635 in Healthy Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06286475.
All > Omaha
~0 spots leftby May 2024
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