AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

A Pilot, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Tolerability, Safety, and Pharmacokinetics of a Single Intra-articular Injection of CNTX-0066 in Participants with Chronic, Moderate-to-Severe Osteoarthritis Knee Pain

This research study is looking at a new potential treatment called CNTX-0066 for adults who have ongoing, moderate to severe knee pain caused by osteoarthritis. Osteoarthritis is a condition where the cartilage in the knee joint wears down. This is a very early-stage study, often called a 'Phase I' study. This means the main goals are to carefully check how safe the new medicine is, how well people tolerate it (meaning, if they have side effects), and how the body processes the medicine after a single injection directly into the knee joint. Participants will be randomly assigned to receive either the new medicine or a placebo (a dummy injection that looks the same but contains no active medicine). The aim is to gather initial information to see if this treatment might be useful in the future to help people with knee osteoarthritis pain.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Centrexion Therapeutics Corp.

Enrolment target

Start

24 Feb 2026

Osteoarthritis of the knee

What is this study about?

If you experience ongoing pain in your knee due to osteoarthritis, you know how much it can affect your daily life. This research study is trying to understand more about a new medicine called CNTX-0066, which is designed to be injected directly into the knee joint. The goal is to see if this medicine could potentially help people manage their moderate to severe osteoarthritis knee pain.

This is a 'Phase I' study, which means it's one of the very first times this medicine is being tested in people. Because it's so early, the main things the researchers want to find out are how safe the medicine is and if people can comfortably tolerate it without too many side effects. They also want to learn how your body handles the medicine – how long it stays in your system and how it's processed.

Participants in this study will receive a single injection directly into their knee. Some people will get the new medicine, while others will get a placebo. A placebo is a substance that looks exactly like the medicine but doesn't contain any active ingredients. This helps researchers compare the effects of the new medicine accurately. This careful approach helps doctors learn if the new medicine is promising enough to test further in larger studies, with the ultimate hope of finding better ways to help people with knee osteoarthritis.

Key takeaways

This study is testing a new injection for knee osteoarthritis pain.
It's an early-stage study focusing on safety and how the body handles the medicine.
Participants will receive either the new medicine or a placebo injection.
The study is for adults aged 18 and over with moderate to severe knee pain.
Taking part helps advance research, but direct benefit isn't guaranteed.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for adults aged 18 and over who have long-lasting, moderate to severe pain in their knee due to osteoarthritis. Both men and women can take part. To be considered, your knee pain should be present most days and be at a level that significantly affects you.

There will be other specific health requirements for joining the study. For example, the study team will need to check your general health, any other medical conditions you might have, and medications you are currently taking. These checks are important to ensure your safety if you participate.

If you're interested, the study team will go through a full list of these requirements with you to see if the study would be a good fit. It’s always best to discuss your individual situation with them or your own doctor.

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 ongoing, moderate to severe pain in your knee due to osteoarthritis?
Are you willing to discuss your full medical history and current medications with the study team?
Are you able to attend regular follow-up appointments at the study clinic?
Are you comfortable with receiving an injection into your knee joint?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first go through a screening process to make sure you meet all the requirements. This might involve a physical exam, blood tests, and other health checks. If you're eligible, you will be in the study for a period of time, likely several weeks or months (the exact duration will be explained by the study team).

A key part of the study involves receiving a single injection of either the study medicine (CNTX-0066) or a placebo directly into your affected knee joint. Neither you nor the study doctors will know whether you received the active medicine or the placebo. After the injection, you will have several follow-up visits to the clinic. During these visits, the study team will closely monitor your health, ask about any pain or side effects you might be experiencing, and collect blood samples to understand how your body is handling the medicine. You may also need to fill out questionnaires about your pain and daily activities. The study will end with a final follow-up assessment.

Potential risks and benefits

Like all medical studies, there are potential benefits and risks. You might not directly benefit from taking part, as some participants will receive a placebo, and the new medicine is still in its early testing stages. However, you would be helping researchers learn more about knee osteoarthritis and potentially contribute to developing new treatments for others in the future. Potential risks might include discomfort or bruising at the injection site, or possible side effects from the study medicine itself, though patient safety is closely monitored. You will receive a full explanation of all possible side effects before you decide to join. It is very important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Denmark

Common questions

What is osteoarthritis of the knee?

Osteoarthritis is a common condition where the smooth cartilage covering the ends of bones in your knee joint gradually wears down. This can cause pain, stiffness, and swelling.

What does 'Phase I' mean for a study?

A 'Phase I' study is an early stage of clinical research. Its main purpose is to test the safety of a new medicine, find the right dose, and see how the body handles it.

What is a placebo?

A placebo is an inactive substance that looks exactly like the medicine being tested but contains no active drug. It helps researchers compare the effects of the actual medicine.

Will I know if I get the actual medicine or the placebo?

No, this is a 'double-blind' study, meaning neither you nor the study doctor will know whether you received the active medicine or the placebo until after the study is complete. This helps keep the results unbiased.

Why is this study important?

This study is important because it's helping researchers investigate a new potential way to treat knee pain caused by osteoarthritis. Finding new treatments could help improve the quality of life for many people.