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To Evaluate the Safety, Tolerability and Pharmacokinetics of Oral NNZ-2591 in Healthy Volunteers

Phase 1
Completed
Conditions
Healthy Volunteers
Interventions
Drug: NNZ-2591
Drug: Placebo
Registration Number
NCT04379869
Lead Sponsor
Neuren Pharmaceuticals Limited
Brief Summary

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of NNZ-2591 when administered to healthy volunteers.

Detailed Description

This study is in two stages:

Stage 1: A First-in-Human (FIH), single dose escalation study of oral NNZ-2591 in healthy volunteers to establish safety, tolerability and pharmacokinetic parameters.

Stage 2: A First-in-Human (FIH), randomised, double-blind, placebo-controlled, Multiple Ascending Dose study (MAD) in healthy volunteers to establish safety, tolerability and pharmacokinetic parameters.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
28
Inclusion Criteria
  1. Male or female subjects aged 18 to 55 years, inclusive;

  2. Weight at screening and admission between 45 kg and 100 kg;

  3. Body mass index (BMI) between 18.0 and 32.0 kg/m2 inclusive;

  4. Healthy as determined by the Investigator based on pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead electrocardiogram (ECG);

  5. Negative tests for Hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV) and human immunodeficiency virus (HIV)-1 and HIV-2 antibody at screening;

  6. Clinical laboratory test results up to >1.5 x Lower Limit of Normal (LLN) or <1.5 x Upper Limit of Normal (ULN) at screening and admission and deemed not clinically significant by the Investigator;

  7. Negative screen for alcohol and drugs of abuse at screening and admission;

  8. Non-smokers or ex-smokers (must have ceased smoking >3 months prior to screening visit);

    If female:

  9. Woman with no childbearing potential by reason of surgery or at least 1year post- menopause (i.e., 12 months post last menstrual period), and menopause confirmed by follicle-stimulating hormone (FSH) testing;

  10. If of childbearing potential, using an effective nonhormonal method of contraception (intrauterine device; condom or occlusive cap [diaphragm or cervical or vault caps]; true abstinence; or vasectomized male partner (provided that he is the sole partner of that subject and had a vasectomy ≥30 days prior to screening) for the duration of the study and up to one month after the last investigational medicinal product (IMP) administration;

  11. Negative serum pregnancy test at screening and negative urine pregnancy test on admission (women of childbearing potential only);

    If male:

  12. Using an effective method of contraception (condom) if sexually active with a female partner of child-bearing potential; true abstinence; or vasectomy ≥30 days prior to screening) throughout the study and for one month after the last IMP administration.

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Exclusion Criteria
  1. Subjects who have a clinically relevant history as determined by the Investigator, or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders;

  2. Fridericia's correction factor for QT (QTcF) > 450 ms for male participants and >470ms for female participants or history of QT interval prolongation.

  3. Have a clinically relevant surgical history, as determined by the Investigator;

  4. Have a history of relevant atopy or drug hypersensitivity;

  5. Have a history of alcoholism or drug abuse;

  6. Consume more than 21 standard drinks a week for males and more than 14 standard drink if female [1 standard drink is any drink containing 10g of alcohol, regardless of container size or alcohol type].

  7. Have a significant infection or known inflammatory process on screening or admission;

  8. Have acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea, heartburn) at the time of screening or admission;

  9. Have used any prescription or non-prescription medicines within 2 weeks of admission, unless in the investigator's opinion will not affect determination of safety or other study assessments. Occasional paracetamol use (up to 2g/day is permitted);

  10. Have received any investigational drug within 30 days prior to screening;

  11. Have used tobacco or nicotine products within 3 months of screening

  12. Have donated or received any blood or blood products within the 3 months prior to screening;

  13. Cannot communicate reliably with the investigator;

  14. Are unlikely to co-operate with the requirements of the study;

  15. Are unwilling or unable to give written informed consent.

    If female:

  16. Pregnancy or breast-feeding;

  17. Woman of childbearing potential not willing to use an accepted effective contraceptive method or using hormonal contraceptives;

    If male:

  18. Not willing to use an accepted effective method of contraception.

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
NNZ-2591 MAD Cohort 2PlaceboMultiple Ascending Dose (MAD) of oral NNZ-2591 in healthy volunteers
NNZ-2591 MAD Cohort 1PlaceboMultiple Ascending Dose (MAD) of oral NNZ-2591 in healthy volunteers
NNZ-2591 MAD Cohort 1NNZ-2591Multiple Ascending Dose (MAD) of oral NNZ-2591 in healthy volunteers
NNZ-2591 Single dose Cohort 1NNZ-2591Single dose of oral NNZ-2591 in healthy volunteers
NNZ-2591 Single dose Cohort 2NNZ-2591Single dose of oral NNZ-2591 in healthy volunteers
NNZ-2591 MAD Cohort 2NNZ-2591Multiple Ascending Dose (MAD) of oral NNZ-2591 in healthy volunteers
Primary Outcome Measures
NameTimeMethod
Safety and Tolerability measured through Adverse Events /Serious Adverse Events25 days

The frequency and severity of Adverse Events in healthy volunteers administered single and repeated oral doses of NNZ-2591

Secondary Outcome Measures
NameTimeMethod
Pharmacokinetic - t1/217 days

Terminal elimination half-life

Pharmacokinetic - AUC∞17 days

Area under the concentration-time curve from time 0 to infinity of NNZ-2591

Pharmacokinetic - Cmax17 days

Maximum observed plasma concentration (Cmax) of NNZ-2591

Pharmacokinetic - Tmax17 days

Time to Cmax of NNZ-2591

Trial Locations

Locations (2)

Scientia Clinical Research

🇦🇺

Sydney, New South Wales, Australia

Linear Clinical Research, The Queen Elizabeth II Medical Centre

🇦🇺

Nedlands, Western Australia, Australia

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