CompletedPhase IInterventional

A phase 1 open-label study to assess the safety and PK of novel CBD soft-gel capsule

This study is looking into a new soft-gel capsule form of Cannabidiol (CBD), a natural compound from the cannabis plant. Researchers want to understand how well the body absorbs and uses this new CBD, and to confirm it's safe for healthy people. Currently, many CBD products aren't absorbed very well, making them less effective. This trial will compare two different doses of the new CBD capsule (NW300EMCBD) against an already approved CBD medicine called Epidyolex. Participants will take each type of CBD and have their bodies' response monitored. The aim is to find an improved CBD formulation that works effectively with minimal side effects for future medical uses, potentially for people at high risk of psychosis.

At a glance

Status

Completed

Phase

Phase I

Sponsor

Clerkenwell Health

Enrolment target

Start

26 Aug 2025

Estimated completion

25 Sep 2025

Healthy volunteers. Intended indication is Clinical High Risk for Psychosis (CHR-P).

What is this study about?

This research study is about a new way to take Cannabidiol, or CBD. CBD is a natural substance found in the cannabis plant that scientists believe could help with various medical and mental health problems. There's already a CBD medicine called Epidyolex that's approved for treating epilepsy. However, most CBD products you take by mouth don't get absorbed very well by the body. This means you might need to take a lot of it for it to have an effect.

This study is testing a new CBD capsule that's designed to be much better absorbed by your body. The main goal is to find out if this new CBD is safe for healthy people and to see exactly how your body handles it – how quickly it gets into your system, how long it stays there, and how it's removed. We want to find the best dose and way to give this new CBD so it works well and causes as few side effects as possible.

To do this, we'll be comparing two different doses of this new CBD capsule (called NW300EMCBD) with Epidyolex. This will help us understand if the new CBD is an improvement on what's currently available. While this study is in healthy volunteers, the new CBD is eventually hoped to help people who are at a higher risk of developing psychosis.

Key takeaways

Testing a new CBD capsule to see how well it's absorbed and if it's safe.
Compares the new CBD with an existing CBD medicine called Epidyolex.
For healthy volunteers aged 18-55 years.
Involves multiple clinic stays (about 6 days each) and blood tests.
Study lasts around 105 days in total.
Potential for mild side effects like tiredness or upset stomach; blood draws have minimal risks.

Who may be eligible?

This study is looking for healthy volunteers, both men and women, between 18 and 55 years old. To take part, you need to be generally healthy, which means having no major health problems that show up in medical checks like blood tests or heart scans.

You also need to be at a healthy weight, with your Body Mass Index (BMI) between 19 and 30. It's important that you haven't taken part in another research study in the last 90 days. You also can't use cannabis products (like oils or edibles) in the 28 days before the study starts.

There are also some things you'll need to avoid during the study, like grapefruit, St John’s wort, alcohol, and tobacco for certain periods. You can't be taking most regular medications, but common painkillers like paracetamol are usually okay. You also need to be willing to follow all the study instructions, including eating specific meals and staying at the clinic when required.

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 between 18 and 55 years old?
Are you generally healthy with no major medical conditions?
Is your BMI (Body Mass Index) between 19 and 30?
Have you avoided cannabis products for at least the last 28 days?
Are you able to avoid alcohol, tobacco, grapefruit, and certain herbal remedies during the study?
Are you willing to stay at a clinic for several days during the study?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be one of the healthy volunteers. You'll move through three different treatment periods, and in each one, you'll receive a different CBD treatment in a mixed-up order. These treatments are:

* **Regimen A:** Two 300 mg capsules of the new NW300EMCBD, taken after a high-fat, high-calorie meal. * **Regimen B:** Three 300 mg capsules of the new NW300EMCBD, also taken after a high-fat, high-calorie meal. * **Regimen C:** Doses of Epidyolex solution, given as two separate amounts 12 hours apart, each after a high-fat, high-calorie meal.

After each treatment period, there will be at least a 25-day 'washout' period where you don't take any study medication. For each treatment period, you'll need to stay at a clinical research site for about 6 days (from the day before you take the medicine until 5 days after). After this, you'll have several outpatient visits until the end of that period. Your blood will be taken regularly to see how your body is handling the medication.

Finally, you'll have a last visit about 25 days after your very last dose. The whole study will take around 105 days, including a screening period and all the treatment periods and visits. In total, you can expect about 29 visits, many of which involve staying at the clinic.

Potential risks and benefits

This study is primarily about checking safety, so there's no direct medical benefit to you as a healthy volunteer. However, your participation will help scientists learn more about new CBD treatments, which could potentially help others in the future. Previous studies with CBD have shown it's generally safe and well-tolerated, even at high doses. The most common side effects have been tiredness, upset stomach, and sleep problems. Some people might also feel a little drowsy. The main risks in this study involve the need for regular blood tests. When blood is taken, you might feel a short sting or discomfort. There's a small chance of bruising, swelling, or, very rarely, an infection where the needle went in. Some people might feel dizzy or faint during or after blood draws. Trained medical staff will perform all procedures carefully to keep you safe. Remember, you can choose 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.

Fortrea Clinical Research Unit Limited
City only
Leeds, England

Common questions

What is CBD?

CBD, or Cannabidiol, is a natural compound found in the cannabis plant. It's being studied for its potential health benefits, but it doesn't cause the 'high' associated with cannabis.

What is Epidyolex?

Epidyolex is a CBD-based medicine that is already approved for treating certain types of epilepsy.

Why do I need to eat a high-fat, high-calorie meal?

Eating certain foods can help the body absorb some medicines better, so a specific meal is used to make sure the CBD is absorbed consistently during the study.

Will I have to stay at the clinic?

Yes, for each of the three treatment periods in the study, you will need to stay at the clinic for about 6 days while you take the study medication and have tests.

Can I use other cannabis products?

No, you cannot use any cannabis products, including hemp, oils, edibles, or drinks, for at least 28 days before the study starts and throughout the study period.

How to find out more

Rebeca James

CROteam@clerkenwellhealth.com - Official trial record

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