SAD and MAD of NT-0167 in healthy volunteers

Suspended

Conditions: Neurodegenerative diseases
Inflammatory disorders

Registration Number: NL-OMON23660

Lead Sponsor: odThera

Brief Summary: .A.

Detailed Description: Not available

Recruitment & Eligibility

Status: Suspended

Sex: Not specified

Target Recruitment: 80

Inclusion Criteria

Eligible subjects must meet all of the following inclusion criteria at screening:
1. Signed informed consent and willing and able to comply with the study protocol;
2. Healthy men or women of non-child bearing potential (WONCBP), 18 to 55 years of age (inclusive) at screening. The health status is verified by absence of evidence of any clinically significant active or uncontrolled
chronic disease following a detailed medical history, a complete physical examination including vital signs, laboratory measurements, and 12-lead ECG;
3. Female subjects must be of non-childbearing potential in accordance with one of the following definitions:
• Surgically sterile (by hysterectomy and/or bilateral oophorectomy and/or bilateral salpingectomy) as documented
by a surgical report or by ultrasound, or
• Post-menopausal (age-appropriate spontaneous amenorrhoea for =12 months and follicle-stimulating hormone (FSH) = 40 IU/mL together with the absence of oral contraceptive use for >12 months);
4. Male volunteers agree to use barrier protection when they engage in sexual relations with women of childbearing potential (WOCBP) or lactating women for the duration of their participation in the study and until 90 days after EOS.
5. Body mass index (BMI) between 18 and 32 kg/m2, inclusive, and with a minimum bodyweight of 50 kg;
6. Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions.
7. Have the intention to be reachable by mobile phone or e-mail during the whole study period

Exclusion Criteria

Eligible subjects must not meet any of the following exclusion criteria at screening or pre-dose:
1. Lactating females;
2. Female volunteers with a positive pregnancy test at screening or baseline prior to IMP administration;
3. Evidence (including symptoms, physical signs, and/or laboratory values) of any active or chronic disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study, or that would pose an unacceptable risk to the
subject in the opinion of the investigator;
4. Any confirmed or suspected disease or condition associated with immune system impairment, including auto-immune diseases, HIV, asplenia or recurrent severe infections.
5. Use of chronic (more than 14 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;
6. Any history of severe allergic reaction(s);
7. Any confirmed significant drug hypersensitivity reactions (including skin reactions or anaphylaxis), or known allergies (non-active hay fever is acceptable);
8. History of clinically significant systemic disorders including haematological, renal, endocrine, gastrointestinal, hepatic, cardiovascular, pulmonary, dermatological and neurological
disorders, or other conditions which could interfere with the interpretation of the study results or compromise the health of the volunteers;
9. Any history of psychiatric condition that may affect participation in the study or preclude compliance with the protocol;
10. Receipt of any vaccination, other than an influenza vaccine, within 3 months of IMP administration.
11. Participation in an investigational drug, vaccine or device study within 3 months prior to first dosing or plans to participant in other investigational drug, vaccine or device research during the study period.
12. Any nutrients known to modulate CYP enzymes activity (e.g., grapefruit or Seville orange containing products or quinine containing drinks (tonic water or bitter lemon)) will not be permitted from 5 days before dosing until the final PK sample is collected;
13. Donation (or loss) of whole blood of 400 ml or more during the 12 weeks prior to IMP administration;
14. Donation of plasma or platelets during the 8 weeks prior to IMP administration;
15. Any other known factor, condition, or disease that, in the opinion of the Investigator, might interfere with treatment compliance, study conduct or interpretation of the results, or may compromise volunteer safety.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tolerability / safety endpoints<br>• Treatment-emergent (serious) adverse events ((S)AEs)<br>• Clinical laboratory tests<br>o Haematology<br>o Chemistry<br>o Urinalysis<br>o Coagulation<br>o Thyroid function tests<br>• Vital signs<br>o Pulse Rate (bpm)<br>o Systolic blood pressure (mmHg)<br>o Diastolic blood pressure (mmHg)<br>o Respiratory Rate (breaths/min)<br>• Electrocardiogram (ECG)<br>o Heart Rate (HR) (bpm), PR-, QRS-, and QTcF-intervals<br>o Morphological abnormalities<br>• Holter ECG (not in Food cohort)<br>• Physical examination<br>• Weight (only during MAD cohorts)

Secondary Outcome Measures