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

A PHASE 1, RANDOMIZED, DOUBLE-BLIND, PARALLEL AND PLACEBO-CONTROLLED SINGLE AND MULTIPLE ASCENDING DOSE TRIAL INVESTIGATING SAFETY, TOLERABILITY AND PHARMACOKINETICS OF LIB-01 IN HEALTHY PARTICIPANTS

This study is looking at a new potential medicine called LIB-01. It's designed for men who experience erectile dysfunction. This is an early-stage study, meaning it's the very first time this medicine is being tested in people. The main goals are to check if LIB-01 is safe to use, how well healthy men tolerate it, and how the body handles the medicine – for example, how much is absorbed and how quickly it's removed. Participants will be healthy men, and they'll either receive the new medicine or a dummy treatment (placebo). This helps us understand the medicine's effects better. It's an important step in developing new treatments.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Dicot AB, Dicot AB

Enrolment target

Start

14 Aug 2023

Erectile dysfunction

What is this study about?

This clinical trial is all about a new medicine, called LIB-01, which is being developed to help men with erectile dysfunction. Erectile dysfunction is when a man has difficulty getting or keeping an erection firm enough for sex. This can be a distressing condition, so new treatments are always being explored.

This particular study is a very early step in the research process. It's called a 'Phase 1' study, which means it's the first time this new medicine is being given to humans. Up until now, it would have only been tested in laboratories. The main purpose at this stage isn't to see if it cures erectile dysfunction, but rather to make sure it's safe for people to take.

Researchers will be carefully watching for any side effects and will also study how the medicine behaves in the body – for example, how much of it gets into the bloodstream and how long it stays there. Some participants will receive the actual medicine, while others will receive a 'placebo' – a dummy pill that looks just like the real medicine but contains no active ingredients. This is a common and important way to understand the medicine's true effects. By understanding safety and how the body processes LIB-01, this study lays the groundwork for future research into its potential to treat erectile dysfunction.

Key takeaways

This study is testing a new medicine (LIB-01) for erectile dysfunction for the first time in healthy men.
The main goals are to check the medicine's safety, how well it's tolerated, and how the body processes it.
Participants will either receive the new medicine or a dummy treatment (placebo).
It's an early-stage study, focusing on safety rather than whether it cures the condition yet.
You must be an adult male and in good general health to be considered.
Participation involves regular clinic visits and close medical monitoring.

Who may be eligible?

This study is specifically looking for healthy male volunteers. You would need to be at least 18 years old to take part. There isn't an upper age limit mentioned, but you would still need to be in good general health.

Being 'healthy' means you don't have any significant ongoing medical conditions, and you're not taking medications that could interfere with the study. The medical team will do thorough checks to confirm your health status and make sure it's safe for you to participate.

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 a man?
Are you 18 years old or older?
Are you generally in good health?
Are you able to attend regular clinic appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would first have a screening visit to make sure you're suitable. This would involve medical checks and tests. If you qualify, you'd be given either the new medicine (LIB-01) or a placebo. You wouldn't know which one you're receiving, and neither would the study team, until the end of the trial.

The study involves taking the medicine in different doses, both a single dose and then multiple doses over a period. You would have regular visits to the clinic for check-ups, blood tests, and to report any side effects. The study team will explain exactly how many visits, how long each visit might be, and the total duration of your participation, including any follow-up appointments after you stop taking the medicine.

Potential risks and benefits

Taking part in a trial always has potential benefits and risks. A potential benefit is contributing to medical science and helping to develop new treatments for erectile dysfunction, which could help many men in the future. You would also receive close medical attention and monitoring. However, there are potential risks, including side effects from the new medicine, which are currently unknown and will be closely monitored. There's also the chance you might receive the placebo and not the active medicine. You have the right 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
Sweden

Common questions

What is 'Phase 1' of a clinical trial?

Phase 1 is the very first stage where a new medicine is given to people. The main goal is to check its safety and how the body handles it, rather than yet testing if it works for a specific condition.

What does 'placebo-controlled' mean?

It means some participants will receive the new medicine, while others will receive a 'dummy' pill that looks the same but has no active ingredients. This helps researchers truly see the effects of the medicine.

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

No, neither you nor the study team will know during the study. This is called 'double-blind' and it helps make sure the results are fair and unbiased.

What does 'erectile dysfunction' mean?

Erectile dysfunction is when a man regularly has trouble getting or keeping an erection firm enough for sexual activity.

Will I be paid for taking part?

The study team will provide full details about reimbursement for your time and travel expenses. This will be explained clearly during the consent process.