Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A Phase I (First-in-Human) Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CAN10, an Anti-IL1RAP Monoclonal Antibody, in Healthy Subjects and in Subjects with Mild to Moderate Plaque Psoriasis

This research is looking at a new potential medicine called CAN10. It's designed to treat plaque psoriasis, a condition that causes red, scaly patches on the skin. The main aims of this study are to see how safe CAN10 is, if people can tolerate it well (meaning if they have uncomfortable side effects), and how the body handles the medicine. Researchers also want to understand how CAN10 affects the body. It's a very early-stage study, meaning it's the first time this medicine is being given to people. It will first involve healthy volunteers, and then people who have mild to moderate plaque psoriasis will be included.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Otsuka Pharmaceutical Development & Commercialization Inc.

Enrolment target

112

Start

10 Aug 2023

Plaque psoriasis

What is this study about?

This study is a very early step in developing a new medicine, CAN10, for plaque psoriasis. Plaque psoriasis is a common skin condition where skin cells grow too quickly, leading to red, flaky, crusty patches covered with silvery scales. The new medicine, CAN10, is a type of 'monoclonal antibody' which is a special protein designed to target specific things in the body, in this case, something called IL1RAP, which is thought to play a role in psoriasis.

The main goals of this study are to make sure CAN10 is safe for people and to see what dose might be best. The researchers will also be watching to see how the body absorbs, uses, and gets rid of the medicine. It's called a 'first-in-human' study because it's the very first time this particular treatment is being given to people, both healthy volunteers and those with plaque psoriasis.

Understanding how CAN10 works and whether it has any unwanted side effects now could help doctors and scientists decide if it's worth continuing to test it in larger studies for people with plaque psoriasis in the future.

Key takeaways

This is an early study of a new medicine for psoriasis.
It's checking safety and how the medicine works in the body.
Both healthy people and those with mild to moderate psoriasis can join.
Participants may receive the new medicine or a dummy treatment.
Regular health checks and clinic visits are part of taking part.

Who may be eligible?

This study is looking for both healthy volunteers and people who have been diagnosed with mild to moderate plaque psoriasis. Participants must be at least 18 years old; there isn't an upper age limit mentioned.

Because this is a very early study, the specific medical 'ins and outs' of who can join will be quite detailed. For people with psoriasis, the study will likely be looking for those whose condition is not too severe, as they specify 'mild to moderate'.

If you're interested, the research team will ask you questions about your general health, any other medical conditions you have, and any medicines you are currently taking. This is to make sure the study is safe for you and that the results will be clear.

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 18 years old or older?
Do you have plaque psoriasis, or are you healthy and willing to be a volunteer?
Are you able to attend regular clinic visits?
Are you comfortable with receiving either the new medicine or a placebo?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to a clinic over a period of time. You would have detailed health checks, including blood tests, and possibly other assessments like skin exams for psoriasis. You would receive the study medicine, CAN10, or a placebo (a dummy medicine with no active ingredients). Which one you receive is decided by chance, and neither you nor the study team will know during the study – this is called 'double-blind'. After receiving the treatment, there would be follow-up visits to monitor your health and how the medicine is affecting you. The total duration of your involvement, including all visits and follow-up, would be fully explained before you agree to take part.

Potential risks and benefits

Potential benefits of joining could include contributing to medical science and potentially receiving a new treatment that might help your psoriasis if you have the condition. However, because this is an early-stage study, the main aim is to understand safety, not necessarily to treat your psoriasis effectively. Potential risks could include side effects from the study medicine, similar to any medicine you take. There might also be discomfort from assessments like blood tests. You will be given all the information about potential risks and benefits before you agree to join, and you are free to withdraw from the study at any time without giving a reason.

Locations (1)

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

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Unverified
Germany

Common questions

What is a 'first-in-human' study?

It means this is the very first time this new medicine is being given to people, starting with healthy volunteers, to check its safety and how the body handles it.

What is plaque psoriasis?

It's a skin condition that causes red, scaly, and itchy patches on the skin, often on the elbows, knees, scalp, and lower back.

Will I definitely get the new medicine?

No, some participants will receive the new medicine (CAN10), and others will receive a placebo (a dummy treatment). Neither you nor the doctors will know which you are getting during the study.

How long will the study last if I join?

The exact length would be explained by the study team, but it will involve several visits to the clinic over a period of time, followed by further check-ups.

Can I leave the study at any time?

Yes, you are always free to leave the study at any point, for any reason, and it will not affect your future medical care.