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

A Phase 1 Randomized, Placebo-Controlled, Double-Blind Study of the Safety, Tolerability and Pharmacological Effects of PT00114 in Healthy Volunteers

This research study, called a Phase 1 trial, is looking at a new medicine called PT00114. This medicine is being developed to help people with mood disorders. For the very first time, this study will give PT00114 to humans – specifically, healthy adult volunteers. The main goals are to check if the medicine is safe, if people can take it without too many problems, and how it works in the body. Researchers want to understand these things before it can be tested in people who actually have mood disorders. Participants will be carefully monitored throughout the study to ensure their well-being.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Protagenic Therapeutics Inc.

Enrolment target

Start

02 Jul 2025

Phase I study in healthy male and female volunteers. Intended indication: mood disorders

What is this study about?

This study is about a new medicine called PT00114. It's designed to help people who experience mood disorders. Before any new medicine can be used widely, it goes through several stages of testing. This particular study is called a 'Phase 1' trial, which is the very first stage where a new medicine is given to people. The main purpose at this early stage is to understand if the medicine is safe for humans and how the body reacts to it. It's crucial to gather this information before the medicine can be tested in people who actually have the condition it's meant to treat.

In this study, researchers are looking for healthy volunteers, both men and women, who are 18 years old or older. You don't need to have a mood disorder to take part in this specific study. By testing the medicine in healthy individuals first, scientists can get a clearer picture of its basic effects on the body without the complications of an existing illness. This helps them learn about the correct dose and any potential side effects.

The information gathered from this Phase 1 trial will be vital. It will help scientists decide if PT00114 is promising enough to move on to the next stages of research, where it would be tested in people living with mood disorders. Your involvement, if you choose to participate, would play an important part in the early development of a potential new treatment.

Key takeaways

This is a first-time-in-human study for a new medicine for mood disorders.
It aims to check the safety and how the body processes the new medicine.
Healthy volunteers, aged 18 and over, are needed.
Participants will receive either the new medicine or a dummy treatment.
Close monitoring will be in place throughout the study.
Your participation could help develop future treatments.

Who may be eligible?

To join this study, you need to be a healthy adult. This means you generally feel well and don't have any significant ongoing health problems. Both men and women are welcome to participate.

You must be at least 18 years old to take part. There is no upper age limit for this study, as long as you meet the other health requirements.

Since this is one of the first times this medicine is being given to humans, the researchers will carefully check your health to make sure it's safe for you to join. They will ask you about your medical history and perform some health checks.

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 generally healthy?
Are you 18 years old or older?
Are you willing to attend clinic visits and potentially stay overnight?
Are you able to follow study instructions carefully?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned to either receive the new medicine (PT00114) or a dummy treatment (placebo). Neither you nor the study team will know which you are receiving – this is known as a 'double-blind' study. You'll have several visits to the study clinic, including some overnight stays, where you'll receive the medicine and have various health checks, such as blood tests, heart readings (ECG), and blood pressure measurements. Researchers will monitor you closely to see how your body reacts to the medicine and if there are any side effects. The total length of your involvement will be explained in detail before you agree to join.

Potential risks and benefits

Every study has potential benefits and risks. You might not directly benefit from taking part, but your involvement will help scientists learn more about this new medicine, which could eventually help others with mood disorders. Potential risks include feeling unwell, allergic reactions, or other side effects from the medicine or procedures like blood tests. You will be closely monitored, and you have the right to withdraw from the study at any time, for any reason, without it affecting your 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
Germany

Common questions

What is a 'Phase 1' study?

It's the first time a new medicine is given to people, usually healthy volunteers, to check its safety and how the body handles it.

What is a 'placebo'?

A placebo is a dummy treatment that looks like the real medicine but contains no active drug. It helps compare the new medicine's effects.

Will I know if I'm getting the real medicine or the placebo?

No, this is a 'double-blind' study, meaning neither you nor the study team will know. This helps make the study results more accurate.

What are mood disorders?

Mood disorders are conditions that affect a person's emotional state, such as depression or bipolar disorder. This medicine aims to help these conditions.

Do I have to pay to participate?

No, you will not have to pay to be in the study, and some studies offer payment for your time and travel expenses.