Effects of NT-0796 in Healthy Volunteers and Patients with Parkinson’s Disease
Key facts
- Where
- Groningen, HollandiaSee the site
- Phase
- 1. fázis
Where in Hollandia
- QPS Netherlands B.V.Groningen, HollandiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Nodthera Limited
- Trial code
- EU 2023-503203-29-00
- Record updated
- 2023. szeptember 11.
- Original description
To evaluate the safety and tolerability of the NT-0796 suspension capsule formulation in healthy volunteers and patients with Parkinson’s disease.Read full original descriptionShow less
An Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NT-0796 in Healthy Volunteers and Patients with Parkinson’s Disease.
To evaluate the safety and tolerability of the NT-0796 suspension capsule formulation in healthy volunteers and patients with Parkinson’s disease.
Inclusion: Men or women who have signed informed consent and are willing and able to comply with the study protocol; 18 to 75 years of age (inclusive) at screening; Willing and able to undergo CSF collections via a lumbar puncture; 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; 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.
Exclusion: Pregnant (known to be pregnant, or with a positive pregnancy test at screening or baseline prior to IMP administration) or lactating females; 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; Any confirmed drug hypersensitivity reactions (including skin reactions or anaphylaxis), or other known clinically significant allergies; History of any psychiatric condition or cognitive dysfunction that may affect participation in the study or preclude compliance with the protocol.