Healthy VolunteersPhase 1NCT04379869
To Evaluate the Safety, Tolerability and Pharmacokinetics of Oral NNZ-2591 in Healthy Volunteers
A Phase 1 study testing NNZ-2591 in people with Healthy Volunteers, run by Neuren Pharmaceuticals Limited at 2 sites in Australia.
Trial summary
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of NNZ-2591 when administered to healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- NNZ-2591
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 2 sitesAustralia
- Study dates
- 29 May 2020to 11 Feb 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female subjects aged 18 to 55 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;
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- 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 1year post- menopause (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.
Who cannot join
- 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].
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- 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.
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Linear Clinical Research, The Queen Elizabeth II Medical Centre
Nedlands, Western Australia, 6009
Scientia Clinical Research
Sydney, New South Wales, 2031
About this study
Official title: A Combined Single Dose and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of NNZ-2591 in Healthy Volunteers
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of NNZ-2591 when administered to healthy volunteers.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- NNZ-2591, Placebo
- Keywords
- Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNZ-2591Drug
Single dose of NNZ-2591
PlaceboDrug
Comparator for double-blind MAD
| Study group | Role | What they receive |
|---|---|---|
| NNZ-2591 Single dose Cohort 1 | Experimental | Single dose of oral NNZ-2591 in healthy volunteers Receives: Drug: NNZ-2591 |
| NNZ-2591 Single dose Cohort 2 | Experimental | Single dose of oral NNZ-2591 in healthy volunteers Receives: Drug: NNZ-2591 |
| NNZ-2591 MAD Cohort 1 | Experimental | Multiple Ascending Dose (MAD) of oral NNZ-2591 in healthy volunteers Receives: Drug: NNZ-2591; Drug: Placebo |
| NNZ-2591 MAD Cohort 2 | Experimental | Multiple Ascending Dose (MAD) of oral NNZ-2591 in healthy volunteers Receives: Drug: NNZ-2591; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability measured through Adverse Events /Serious Adverse Events
The frequency and severity of Adverse Events in healthy volunteers administered single and repeated oral doses of NNZ-2591
Measured: 25 days
Secondary outcomes (4)
Pharmacokinetic - Cmax
Maximum observed plasma concentration (Cmax) of NNZ-2591
Measured: 17 days
Pharmacokinetic - AUC∞
Area under the concentration-time curve from time 0 to infinity of NNZ-2591
Measured: 17 days
Pharmacokinetic - Tmax
Time to Cmax of NNZ-2591
Measured: 17 days
Pharmacokinetic - t1/2
Terminal elimination half-life
Measured: 17 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2020
- Study start29 May 2020
- Primary completion11 Feb 2021
- Study completion11 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Stage 1: Open-label, single dose with 2 dose cohorts. Stage 2: Randomised, Double-blind, Placebo-controlled, Multiple Ascending Dose (MAD) with 2 dose cohorts
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuren Pharmaceuticals Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Shaw, Study director, Neuren PharmaceuticalsJasmine Williams, Principal investigator, Linear Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04379869
- Sponsor's protocol ID
- NEU-2591-HV-001
- Status last verified
- Jul 2021
- First submitted
- 30 Apr 2020
- Last updated
- 9 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Combined Single Dose and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of NNZ-2591 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04379869
- Acronym / sponsor ID
- NEU-2591-HV-001
- Conditions
- Healthy Volunteers
- Keywords
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Neuren Pharmaceuticals LimitedIndustry (pharma, biotech, devices)
- Study start
- 29 May 2020 (actual)
- Primary completion
- 11 Feb 2021 (actual)
- Study completion
- 11 Feb 2021 (actual)
- First posted
- 8 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Stage 1: Open-label, single dose with 2 dose cohorts. Stage 2: Randomised, Double-blind, Placebo-controlled, Multiple Ascending Dose (MAD) with 2 dose cohorts
| Arm | Type | Receives |
|---|---|---|
| NNZ-2591 Single dose Cohort 1 | Experimental | Drug: NNZ-2591Single dose of oral NNZ-2591 in healthy volunteers |
| NNZ-2591 Single dose Cohort 2 | Experimental | Drug: NNZ-2591Single dose of oral NNZ-2591 in healthy volunteers |
| NNZ-2591 MAD Cohort 1 | Experimental | Drug: NNZ-2591, Drug: PlaceboMultiple Ascending Dose (MAD) of oral NNZ-2591 in healthy volunteers |
| NNZ-2591 MAD Cohort 2 | Experimental | Drug: NNZ-2591, Drug: PlaceboMultiple Ascending Dose (MAD) of oral NNZ-2591 in healthy volunteers |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Male or female subjects aged 18 to 55 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;
Key exclusion criteria (20 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NNZ-2591Single dose of NNZ-2591 | Drug | NNZ-2591 MAD Cohort 1, NNZ-2591 MAD Cohort 2, NNZ-2591 Single dose Cohort 1, NNZ-2591 Single dose Cohort 2 |
| PlaceboComparator for double-blind MAD | Drug | NNZ-2591 MAD Cohort 1, NNZ-2591 MAD Cohort 2 |
Primary outcome
Safety and Tolerability measured through Adverse Events /Serious Adverse Events
Time frame: 25 days
The frequency and severity of Adverse Events in healthy volunteers administered single and repeated oral doses of NNZ-2591
4 secondary outcomes
Pharmacokinetic - Cmax
Time frame: 17 days
Pharmacokinetic - AUC∞
Time frame: 17 days
Pharmacokinetic - Tmax
Time frame: 17 days
Pharmacokinetic - t1/2
Time frame: 17 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Shaw study director
Neuren Pharmaceuticals
Jasmine Williams principal investigator
Linear Clinical Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NNZ-2591 in people with Healthy Volunteers, run by Neuren Pharmaceuticals Limited at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability measured through Adverse Events /Serious Adverse Events (time frame: 25 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2021; AzTrials last refreshed its copy on 8 Nov 2026.