A First-In-Human study to evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of NT-0249 in Healthy Volunteers.

Phase 1

Completed

• Conditions: Inflammatory and Immune System - Other inflammatory or immune system disorders; Inflammation and Immune System; Inflammation

• Registration Number: ACTRN12622000195752
• Lead Sponsor: odThera

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-02-04
• Study Completion: 2023-02-21
• Last Update Posted: 2 August 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 63

Inclusion Criteria

1.Signed informed consent and willing and able to comply with the study protocol;
2.Healthy men or women, 18 to 55 years of age (inclusive) at screening; health status is verified by absence of evidence of any clinically significant acute disease, or 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 not be pregnant or lactating, and women of child-bearing potential (WOCBP) must agree to remain abstinent or use highly effective contraception, and agree to refrain from donating eggs, for 28 days prior to first dose and until 90 days after their last dose of IMP.
4.Male volunteers agree to use barrier protection when they engage in sexual relations with WOCBP, pregnant or lactating women 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;
5.Body mass index (BMI) between 18.0 and 34.0 kg/m2, inclusive, and with a minimum bodyweight of 50 kg;
6.Has the ability to communicate well with the Investigator and willing to comply with the study restrictions;
7.Has the intention to be reachable by mobile phone or e-mail during the whole study period;

Exclusion Criteria

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 acute 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 consecutive 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 drug hypersensitivity reactions (including skin reactions or anaphylaxis), or other known clinically significant allergies;
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.History of any psychiatric condition that may affect participation in the study or preclude compliance with the protocol;
10.History of convulsions or severe head trauma;
11.Recent (within the last three years) and/or recurrent history of autonomic dysfunction (e.g. recurrent episodes of fainting, palpitations, etc.);
12.History of frequent headaches (either severe in nature or requiring continuous daily treatment or treatment more than three times per week on average) and/or chronic, ongoing migraines;
13.History of malignancy (with the exception of localised basal cell carcinoma of the skin);
14.History of asthma (with the exception of fully resolved childhood asthma);
15.History of porphyria;
16.Any previous organ transplantation or donation;
17.Any surgical or medical condition with the potential to affect drug absorption (e.g. gastrectomy, bowel disease), distribution, metabolism or excretion;
18.Any history of arrhythmias or documented prolonged QTcF-interval (greater than 450 msec in males, greater than 470 msec in females), any previous episode of syncope thought to be of cardiac origin, or a family history of long QT syndrome or unexplained sudden death;
19.Clinically significant ECG abnormalities at screening, admission to the clinical research unit (CRU) or baseline prior to IMP administration including but not limited to:
•PR-interval greater than 220 msec
•QRS duration greater than 120 msec
•QT-interval greater than 500 msec
•QTcF-interval greater than 450 msec in males, greater than 470 msec in females
•pathologic Q wave
•significant ST-T wave changes
•second or third-degree A-V heart block
The ECG reading may be repeated in assessing this criterion if the investigator believes that the values from the original reading were erroneous;
20.Resting vital signs (measured after 5 minutes in the supine position) at screening, admission to the clinical research unit (CRU) or baseline prior to IMP administration as follows:
•Tympanic body temperature greater than or equal to 38.0 °C
•SBP less than or equal to 90 or greater than or equal to 140 mmHg
•DB

Study & Design

• Study Type: Interventional
• Study Design: Not specified