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Effects of NT-0796 in Healthy Volunteers and Patients with Parkinson’s Disease
EU CTIS ID: 2023-503203-29-00
What this study is testing
To evaluate the safety and tolerability of the NT-0796 suspension capsule formulation in healthy volunteers and patients with Parkinson’s disease.
- Human Pharmacology (Phase I)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Men or women who have signed informed consent and are willing and able to comply with the study protocol;
- 2. 18 to 75 years of age (inclusive) at screening;
- 3. Willing and able to undergo CSF collections via a lumbar puncture;
- 4. Women of child-bearing potential (WOCBP) must agree to remain abstinent or use highly effective contraception (as defined in section 5.5), and agree to refrain from donating eggs, for 28 days prior to first dose and until 90 days after their last dose of IMP, as defined in the contraceptive requirements section of the full protocol;
- 5. Male participants agree to use barrier protection when they engage in sexual relations with WOCBP for the duration of their participation in the study and until 90 days after their last dose of IMP; they also agree to request their female partners to use an effective method of contraception if they are WOCBP, pregnant or lactating;
You likely can't join if
- 1. Pregnant (known to be pregnant, or with a positive pregnancy test at screening or baseline prior to IMP administration) or lactating females;
- 2. Any confirmed or suspected disease or condition associated with immune system impairment, including auto-immune diseases, HIV, asplenia or recurrent severe infections, or use of chronic (more than 14 consecutive days) immunosuppressant or immunomodulatory drugs within the 6 months prior to IMP administration, or isolated (non-chronic) use within 30 days prior to IMP administration;
- 3. Any confirmed drug hypersensitivity reactions (including skin reactions or anaphylaxis), or other known clinically significant allergies;
- 4. History of any psychiatric condition or cognitive dysfunction that may affect participation in the study or preclude compliance with the protocol;
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.