CompletedPhase IInterventional

A study in healthy male and female volunteers to assess how different formulations of the test medicine (VDPHL01) are taken up by the body

Pattern hair loss affects up to half of all men and women. Researchers are developing a new tablet called VDPHL01 to treat it. Before testing this medicine in people with hair thinning, scientists need to see how the human body takes it in and processes it. In this Phase 1 trial, healthy men and women aged 18 to 55 will try five new slow-release recipes of the medicine and compare them with an approved medicine called minoxidil. Volunteers will complete six separate study periods over roughly 14 weeks. Each period includes a three-night stay in a specialist clinic. Doctors will monitor blood levels, heart rhythm, and overall health to find out which recipe works best and whether it causes any unwanted side effects. Taking part helps researchers develop more effective, convenient treatments for hair loss in the future.

At a glance

Status

Completed

Phase

Phase I

Sponsor

Veradermics Inc

Enrolment target

Start

04 Oct 2023

Estimated completion

13 Feb 2024

Androgenetic alopecia

What is this study about?

Pattern hair loss, also known as androgenetic alopecia, is the most common cause of thinning hair, affecting around half of men and women. It occurs when hair follicles react strongly to natural body hormones, causing the normal hair growth cycle to shorten. Over time, hair strands become thinner, shorter, and less visible.

While treatments such as minoxidil tablets already exist, scientists want to improve how these medicines work. This study tests an experimental tablet named VDPHL01. The researchers have designed modified-release versions of the tablet, which are engineered to release the medicine gently into the bloodstream over several hours rather than all at once.

Because this is an early Phase 1 study, it is carried out in healthy volunteers rather than people seeking hair loss treatment. The main purpose is to measure how quickly the body absorbs the medicine, how long it stays in the blood, and whether food changes how it works. By comparing these new versions with standard minoxidil, researchers can choose the best formula to move forward into future clinical trials.

Key takeaways

Phase 1 study testing five new recipes of a hair loss tablet (VDPHL01).
Open to healthy men and women aged 18 to 55.
Requires six separate clinic stays of three nights each over about 14 weeks.
Compares the new tablet against an already approved minoxidil tablet.
No direct health benefit, but participants receive financial compensation for their time.

Who may be eligible?

This study is open to healthy men and women aged between 18 and 55. To qualify, you must weigh at least 50 kg and have a body mass index (BMI) between 18.0 and 32.0. Because one part of the test checks how food affects absorption, you must be comfortable eating a set high-fat breakfast that contains pork.

You cannot take part if you have major medical conditions affecting your heart, liver, kidneys, or digestive system, or if you have a history of gallstones or gallbladder surgery. You will also be excluded if your blood pressure drops significantly when you stand up, if you have active allergies, or if you test positive for infections such as hepatitis or HIV. Staff will also check that your arm veins are suitable for routine blood draws.

Women who could become pregnant must agree to use highly effective contraception during the study. This is because the medicine has not been proven safe for unborn babies. Pregnant or breastfeeding women cannot join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you in good health and aged between 18 and 55?
Do you weigh at least 50 kg with a BMI between 18.0 and 32.0?
Are you free from major heart, kidney, liver, or gut disorders?
Are you able to spend three nights at a time staying in a clinic across six visits?
Are you willing to eat a high-fat breakfast that includes pork on one visit?
If applicable, are you able to use highly effective contraception throughout the study?

Answer every question to see your result.

What does participation involve?

Taking part lasts up to 14 weeks and is split into six separate periods. For each period, you will stay in a clinic for three nights, with at least one week at home between stays. Across five visits, you will take a single dose of the new test tablet (usually on an empty stomach, but once after a high-fat breakfast). During one visit, you will take a single tablet of an approved minoxidil medicine instead. Medical staff will perform regular health checks, including blood tests, urine tests, blood pressure measurements, and heart traces (ECGs). About five days after your final dose, the team will call you at home for a quick follow-up to check how you are feeling.

Potential risks and benefits

Because you are joining as a healthy volunteer, this study will not provide any direct health benefits to you, but your participation helps scientists create better hair loss treatments for others. You will receive financial compensation for your time, travel, and overnight stays. Potential risks include mild medicine side effects such as light-headedness or headaches, minor bruising or soreness from blood tests, and slight skin redness from heart monitor stickers. A medical team will look after you throughout your clinic stays. Taking part is completely voluntary, and you are free to leave the study at any time.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Quotient Sciences Limited
City only
Nottingham, England

Common questions

Will this study cure or improve my own hair loss?

No. This trial is designed only to measure how the human body handles the medicine in healthy individuals. It is not intended to treat hair thinning in participants.

Will I be paid for taking part?

Yes. Healthy volunteer studies provide a set payment (stipend) to cover your time, travel expenses, and the inconvenience of overnight clinic stays.

What happens during the overnight stays?

You will stay in a comfortable clinical research ward for three nights per visit. Staff will give you your study dose, provide your meals at scheduled times, and take regular blood and heart measurements.

Why do I have to eat a high-fat breakfast with pork?

In one part of the trial, scientists need to see if food changes the way the tablet is digested. Using an identical high-fat meal for everyone ensures the results are fair and reliable.

Can I leave the study early if I change my mind?

Yes. You have the right to leave the trial at any point, for any reason, without any penalty.

How to find out more

Phil Evans

recruitment@weneedyou.co.uk +44 (0)330 303 1000 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.