Effects of NT-0796 in Healthy Volunteers and Patients with Parkinson’s Disease

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Nodthera Limited

Participant type

Healthy volunteers, Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

12 Apr 2023 → 18 Dec 2023

Decision date (initial)

2023-04-12

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

NodThera Ltd

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Safety, Pharmacodynamic, Pharmacokinetic

To evaluate the safety and tolerability of the NT-0796 suspension capsule formulation in healthy volunteers and patients with Parkinson’s disease.

Secondary objectives 3

1. To evaluate the pharmacokinetic (PK) profile of NT-0796 in a suspension capsule formulation in healthy volunteers and patients with Parkinson’s disease.
2. To evaluate the pharmacodynamic (PD) properties of NT-0796 in a suspension capsule formulation in healthy volunteers and patients with Parkinson’s disease.
3. To evaluate PK & PD properties of NT-0796 in cerebrospinal fluid (CSF) samples in healthy volunteers and patients with Parkinson’s disease.

Conditions and MedDRA coding

Parkinson's Disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. 1. Men or women who have signed informed consent and are willing and able to comply with the study protocol;
2. 2. 18 to 75 years of age (inclusive) at screening;
3. 3. Willing and able to undergo CSF collections via a lumbar puncture;
4. 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. 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;

Exclusion criteria 4

1. 1. Pregnant (known to be pregnant, or with a positive pregnancy test at screening or baseline prior to IMP administration) or lactating females;
2. 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. 3. Any confirmed drug hypersensitivity reactions (including skin reactions or anaphylaxis), or other known clinically significant allergies;
4. 4. History of any psychiatric condition or cognitive dysfunction that may affect participation in the study or preclude compliance with the protocol;

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Incidence of treatment-emergent adverse events (TEAEs)
2. Changes in clinical laboratory values

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Auxiliary 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Nodthera Limited

Sponsor organisation

Nodthera Limited

Address

Mansion House, Chesterford Park, Little Chesterford Chesterford Park Little Chesterford

City

Saffron Walden

Postcode

CB10 1XL

Country

United Kingdom

Scientific contact point

Organisation

Nodthera Limited

Contact name

Sarah Director

Public contact point

Organisation

Nodthera Limited

Contact name

Sarah Director

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 2 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications