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

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Recruiting
participants needed

30
sponsor

Neuren Pharmaceuticals Limited

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Updated on 19 February 2024

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HIV Infection

body mass index

serum pregnancy test

vasectomy

follicle stimulating hormone

hepatitis b surface antigen

electrocardiogram

drug abuse

hepatitis

illicit drugs

hepatitis b

drugs of abuse

neurologic examination

12 lead electrocardiogram

Summary

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

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), multiple dose escalation study of oral NNZ-2591 in healthy volunteers to establish safety, tolerability and pharmacokinetic parameters.

Details

Condition	Healthy Volunteers
Age	18years - 65years
Treatment	NNZ-2591
Clinical Study Identifier	NCT04379869
Sponsor	Neuren Pharmaceuticals Limited
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Male or female subjects aged 18 to 65 years, inclusive
	Weight at screening and admission between 45 kg and 100 kg
	Body mass index (BMI) between 18.0 and 32.0 kg/m2 inclusive
	Healthy as determined by the Investigator based on pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead electrocardiogram (ECG)
	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
	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
	Negative screen for alcohol and drugs of abuse at screening and admission
	Non-smokers or ex-smokers (must have ceased smoking >3 months prior to screening visit)
	If female
	\. Woman with no childbearing potential by reason of surgery or at least
	year postmenopause (i.e., 12 months post last menstrual period), and
	menopause confirmed by follicle-stimulating hormone (FSH) testing
	\. 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
	\. Negative serum pregnancy test at screening and negative urine pregnancy
	test on admission (women of childbearing potential only)
	If male
	\. 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
Exclusion Criteria
	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
	Fridericia's correction factor for QT (QTcF) > 450 ms for male participants and >470ms for female participants or history of QT interval prolongation
	Have a clinically relevant surgical history, as determined by the Investigator
	Have a history of relevant atopy or drug hypersensitivity
	Have a history of alcoholism or drug abuse
	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]
	Have a significant infection or known inflammatory process on screening or admission
	Have acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea, heartburn) at the time of screening or admission
	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)
	Have received any investigational drug within 30 days prior to screening
	Have used tobacco or nicotine products within 3 months of screening
	Have donated or received any blood or blood products within the 3 months prior to screening
	Cannot communicate reliably with the investigator
	Are unlikely to co-operate with the requirements of the study
	Are unwilling or unable to give written informed consent
	If female
	\. Pregnancy or breast-feeding
	\. Woman of childbearing potential not willing to use an accepted effective
	contraceptive method or using hormonal contraceptives
	If male
	\. Not willing to use an accepted effective method of contraception

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