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Protease Inhibitor
VX-993 for Healthy Adults
Phase 1
Recruiting
Research Sponsored by Vertex Pharmaceuticals Incorporated
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
A total body weight of more than (>) 50 kg
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Summary
"This trial aims to assess how safe and well-tolerated different doses of VX-993 are when given intravenously to healthy volunteers, as well as how the drug moves through the body."
Who is the study for?
This trial is for healthy adults who have a BMI between 18.0 and 32.0, weigh more than 50 kg, and are non-smokers or have quit smoking for at least three months.
What is being tested?
The study is testing the safety and how the body processes different doses of VX-993, a new drug given through an IV, compared to a placebo in people without any health issues.
What are the potential side effects?
Since this is a Phase 1 trial primarily focused on safety and dosage levels, specific side effects of VX-993 are not yet known but will be closely monitored.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I weigh more than 50 kg.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Part B: Multiple Ascending Dose (MAD)Experimental Treatment1 Intervention
Participants will be randomized to receive multiple doses of different dose levels of VX-993. The dose levels will be determined based on the data from Part A.
Group II: Part A: Single Ascending Dose (SAD)Experimental Treatment1 Intervention
Participants will be randomized to receive a single dose of different dose levels of VX-993.
Group III: Placebo Part APlacebo Group1 Intervention
Participants will be randomized to receive placebo matched to VX-993.
Group IV: Placebo Part BPlacebo Group1 Intervention
Participants will be randomized to receive multiple doses of placebo matched to VX-993.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VX-993
2024
Completed Phase 1
~160
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Vertex Pharmaceuticals IncorporatedLead Sponsor
251 Previous Clinical Trials
32,757 Total Patients Enrolled
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1,221 Patients Enrolled for Pain
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