VX-407 for Safety Evaluation
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial evaluates the safety and tolerability of a new treatment, VX-407, in generally healthy individuals. Participants will be divided into groups to receive either a single dose or multiple doses of VX-407, or a placebo (a substance with no active drug) for comparison. It suits those with a body mass index (BMI) between 18.0 and 32.0, weighing over 50 kg, and who are nonsmokers or have quit smoking for at least three months. The study helps researchers understand how the body processes VX-407, which is crucial for future treatments. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that VX-407 is likely to be safe for humans?
Research has shown that VX-407 has undergone safety testing in healthy individuals using both single and multiple doses. These studies found that VX-407 is generally well-tolerated, with most participants not experiencing serious side effects. However, as these are early trials, the full safety profile is still being explored. Participants should be aware that further information will be collected to ensure its safety.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about VX-407 because it represents a potential new approach to treatment. Unlike current options, which often focus on managing symptoms or slowing progression, VX-407 may offer a novel mechanism of action that targets the underlying cause of the condition more directly. This could mean more effective and possibly faster results for patients. Additionally, VX-407 is being tested in both single and multiple dose forms, which could provide flexibility in treatment plans. This adaptability might lead to more personalized care options in the future.
What evidence suggests that VX-407 could be effective?
Research has shown that VX-407 is under study for its potential benefits in kidney health. This trial evaluates the safety of VX-407, with participants randomized into different groups to receive either a single ascending dose, multiple ascending doses, or a placebo. Early trials focus on understanding the drug's mechanism in the body and ensuring its safety. Although limited information exists from human studies, VX-407 is believed to improve kidney function by targeting specific pathways. Initial results appear promising, but further research is necessary to confirm its effectiveness in treating kidney conditions.14678
Are You a Good Fit for This Trial?
This trial is for healthy individuals who can help researchers understand the safety and how the body processes a new drug, VX-407. Specific eligibility criteria are not provided, but typically participants should have no significant health issues.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part A
Participants receive a single ascending dose of VX-407 or placebo
Treatment Part B
Participants receive multiple ascending doses of VX-407 or placebo
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- VX-407
Trial Overview
The study is testing VX-407 to see if it's safe and how it affects the body compared to a placebo (a substance with no active drug). This early-stage trial will help determine appropriate dosages for future studies.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Placebo Group
Participants will be randomized to receive multiple doses of VX-407.
Participants will be randomized to receive a single dose of VX-407.
Participants will be randomized to receive placebo matched to VX-407.
Participants will be randomized to receive placebo matched to VX-407.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vertex Pharmaceuticals Incorporated
Lead Sponsor
Dr. David Altshuler
Vertex Pharmaceuticals Incorporated
Chief Medical Officer since 2020
MD, PhD
Dr. Reshma Kewalramani
Vertex Pharmaceuticals Incorporated
Chief Executive Officer since 2020
MD, trained in internal medicine and nephrology
Citations
NCT07022119 | A Phase 1 Study Evaluating Safety, ...
The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of VX-407 in healthy participants. Detailed Description. This clinical ...
2.
investors.vrtx.com
investors.vrtx.com/news-releases/news-release-details/vertex-announces-key-advancements-across-kidney-portfolioVertex Announces Key Advancements Across Kidney ...
The final study analysis will occur when subjects have at least two years of eGFR data and when approximately 187 composite clinical outcomes ...
NCT07161037 | Phase 2a Study of VX-407 in Participants ...
A phase of research to describe clinical trials that gather more information about a drug's safety and effectiveness by studying different populations and ...
A Phase 1 Study to Evaluate Safety, Tolerability, and ...
The purpose of the study is to evaluate the safety, tolerability, and pharmacokinetic parameters of VX-407 in healthy participants. Description.
VX-407 - Drug Targets, Indications, Patents
Several of these interventions are in ongoing phase 2 or 3 clinical trials evaluating their safety and efficacy and are discussed in this review.
6.
ctv.veeva.com
ctv.veeva.com/study/a-phase-1-study-to-evaluate-safety-tolerability-and-pharmacokinetics-pk-of-vx-407-in-healthy-parA Phase 1 Study to Evaluate Safety, Tolerability, and ...
This Phase 1 study evaluates the safety, tolerability, and pharmacokinetics of VX-407 in healthy participants, using a single ascending dose ...
7.
news.vrtx.com
news.vrtx.com/news-releases/news-release-details/vertex-reports-third-quarter-2025-financial-resultsVertex Reports Third Quarter 2025 Financial Results
Vertex has resumed dosing in the multiple ascending dose (MAD) portion of the Phase 1/2 study of VX-522, a nebulized CFTR mRNA therapy, for ...
8.
ir.zailaboratory.com
ir.zailaboratory.com/news-releases/news-release-details/vertex-announces-key-advancements-across-kidney-portfolioVertex Announces Key Advancements Across Kidney ...
AGLOW is a 52-week single-arm study that will evaluate the effect of VX-407 on height-adjusted total kidney volume (htTKV) in patients with a ...
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