New antibiotic formula aims to protect kidneys
NCT ID NCT07502144
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tests whether a new formulation of the antibiotic polymyxin B (VRP-034) is safer for the kidneys than the current version. It involves 48 healthy adult men who will receive one or more doses of either the new or standard drug. Researchers will measure kidney injury markers in urine to see if VRP-034 causes less damage.
Why investors are watching
Venus Remedies is testing VRP-034, a new version of the antibiotic polymyxin B, in a Phase 1 trial with 48 healthy men. The trial checks whether this formulation is safer for the kidneys than the standard drug, which is a last-resort treatment for resistant infections but can cause kidney damage. For a small company, a positive safety signal here could make VRP-034 a more attractive product for hospitals and partners.
If it works: If VRP-034 shows less kidney toxicity while keeping the drug's antibacterial effect, Venus Remedies could position it as a safer alternative to standard polymyxin B. That result might lead to licensing deals or a path toward later-stage trials.
If it fails: Phase 1 trials often fail or show no clear benefit, and this one only measures safety and drug levels in healthy volunteers, not real infections. A negative or unclear result could delay the program and hurt the company's credibility with investors.
AI-written from the trial record. Speculative, and not investment advice.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Apr 2026
An estimate. Start dates often move.
- Expected to finish
-
Dec 2026
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 45 years
- Sex
-
Male participants only
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Healthy adult male human subjects aged between 18 and 45 years, both inclusive. * Subjects weight within normal range according to normal values for Body Mass Index 18.50 to 28.00 kg/m2, both inclusive with minimum of 50 kg weight. * Subjects with normal health as determined by personal medical history, clinical examination and laboratory examinations within the clinically acceptable range. * Subject with creatinine Clearance greater than and equal to 90 ml per min. * Subjects with haemoglobin greater than and equal to 11.5 gm percentage at the time of screening. * Subject should be non smoker, non alcoholic. Further details as mentioned in the approved protocol Exclusion Criteria: * Have significant diseases or clinically significant abnormal findings during screening like medical history, physical examination, laboratory evaluations, ECG, and chest X ray. * History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, urogenital or psychiatric disease or disorder. * Use of any hormone replacement therapy within three months prior to admission. * A depot injection or implant of any drug within three months prior to admission * Subjects with G6PD deficiency. * Abnormal USG KUB or clinically significant findings in volunteers * Difficulty with donating blood. * Positive screening test for any one or more i.e HIV, Hepatitis B and Hepatitis C or syphilis RPR. * Any other issue which, in the judgment of the Investigator, will make the subject ineligible for study participation Further details as mentioned in the approved protocol
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Healthy volunteers are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Veeda Clinical Research Ltd
Ahmedabad, Gujarat, 380015, India
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Scientists probe the nerve highways behind strength gains
- New syphilis test kits put to the test with donated blood
- Can a copy of a blockbuster arthritis drug match the original? scientists test it in healthy people
- Novo nordisk tests Brand-New molecule in humans for the first time
- New sedative candidate goes Head-to-Head with propofol in early human test
- Can a Room-Temperature dairy drink build muscle?