Parkinson’s disease is a condition that affects movement, causing symptoms such as slowness, stiffness, tremor, and balance problems. Many people take levodopa to manage these symptoms. Over time, the medication can start to wear off before the next dose is due. Those periods when symptoms return are often called “OFF time,” and they are common first thing in the morning.

The purpose is to evaluate the safety and tolerability of an investigational treatment in adults with Parkinson’s disease and motor fluctuations, to measure how the body processes it, and to explore its effects on the motor features of Parkinson’s disease.

Yes. This is a randomized, placebo-controlled study. Participants are assigned by chance to receive either the investigational treatment or placebo. Across each group of 8 participants, 6 receive the investigational treatment and 2 receive placebo. You, the study doctor, and the team assessing you will not know which one you receive.

It is given one time, as an injection under the skin of the abdomen. The dose is delivered over about 10 minutes using a small device that attaches to the skin and is then removed. The device is fully mechanical, with no electronics, and the needle is inserted once for that single delivery. There are no daily injections and no pills as part of the study treatment.

Screening period: up to 28 days

In-clinic stay: about 8 days. You are admitted the day before your study dose, the dose is given on Day 1, and you go home on the morning of Day 8

Follow-up visit: about one week after you leave the clinic

Overall, participation may last up to about 6½ weeks, depending on scheduling and study completion. Participation is always voluntary.

You will stay at the research clinic and be monitored by the study team. Your heart rhythm is recorded continuously by a telemetry device, with brief breaks allowed so you can shower and stretch. The study team will assess your movement at set times each day and check the injection site. Meals are provided.

Your usual Parkinson’s medications will be temporarily adjusted on some days so the study team can assess you in the OFF state. Medications may be held overnight and for up to about 6 hours after study dosing on specified days. If you or the study doctor feel that your medication needs to be restarted sooner, it may be restarted according to the study protocol.

All study related care is provided at no cost, this includes

– Assigned study drug

– Clinic visits and the in-clinic stay

– Study-related procedures, tests, or exams