Tolerability of NT-301 Nasal SprayPhase 1APPROVENCT06954428

Clinical Trial of Intranasal Delivery of NT-301

A Phase 1 study testing NT-301 1 mg and NT-301 2 mg in people with Tolerability of NT-301 Nasal Spray and Pharmacokinetics of NT-301 Nasal Spray, run by Nano PharmaSolutions Australia at 2 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Tolerability of NT-301 Nasal Spray, Pharmacokinetics of NT-301 Nasal Spray, Safety of NT-301 Nasal Spray
What is being tested?: NT-301 1 mg and NT-301 2 mg
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 49 participants
Where: 2 sitesAustralia
Study dates: 20 Jun 2025to 12 Dec 2025
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 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Male or female participants aged between 18 and 60 years of age, inclusive at the time of signing the informed consent document.
Body weight ≥50 kg and body mass index (BMI) within the range of 18 to 32 kg/m2 inclusive at screening.
Woman of childbearing potential (WOCBP) or fertile male participants must agree to use an acceptable method of contraception from the start of Screening until 90 days (male participants) or 60 days (female participants) after the final study visit.
WOCBP must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to administration of the first dose of study intervention (including domperidone) and be willing to have additional pregnancy tests, as required, throughout the study.
Participants must be in good general health, as demonstrated at screening and prior to first administration of any study intervention (including domperidone) by the absence of clinically significant (in the opinion of the Investigator) abnormalities based on a medical evaluation including review of medical history, physical examination, safety laboratory tests, vital signs, 12-lead ECG monitoring.
Note: It is the responsibility of the Investigator to assess the clinical significance of any abnormality/ies; however, consultation with the MM may be warranted.

Show all 15Show fewer

Normal vital signs after ≥5 min resting in supine position:
≥90 mmHg and ≤160 mmHg systolic blood pressure (SBP)
≥50 mmHg and ≤95 mmHg diastolic blood pressure (DBP)
≥ 45 bpm and ≤100 bpm heart rate (HR)
Body temperature (tympanic) ≥35.5°C and ≤37.7°C
No clinically significant changes and/or associated symptoms considered related to orthostatic hypotension when measuring blood pressure (BP) and pulse rate (PR) within 2 min of standing from a supine position.
Triplicate 12-lead ECG, taken after ≥5 min in a supine, position, with a QT interval corrected using the Fridericia method (QTcF) ≤ 450 msec for males and ≤ 470 msec for females, PR interval ≤ 220 msec or QRS duration ≤ 120 msec or history of long QT syndrome and no clinically significant abnormalities as judged by the Investigator (or qualified designee).
Willing and able to be confined at the CRU for the study period and adhere to overall study visit schedule, procedures and other protocol requirements, as assessed by the Investigator (or qualified designee).
Understands and voluntarily signs an informed consent document prior to any study related assessments/procedures being conducted.

Who cannot join

Any significant medical condition, physical or psychiatric illness or history of depression that could, in the Investigator's (or qualified designee) opinion, compromise the participant's safety or interfere with the completion of this study.
History of clinically significant CNS, cardiac, pulmonary, metabolic, renal, hepatic, or gastrointestinal (GI) conditions including gastric bypass or other weight loss surgical procedure.
Any condition including the presence of laboratory abnormalities, which according to the Investigator (or qualified designee), places the participant at unacceptable risk if they were to participate in the study or may confound the ability to interpret data from the study. This includes the presence of uncontrolled current illness (e.g., an infection), a viral infection, seasonal allergy, or concurrent skin rash.
Any nasal condition, including nasal congestion, physical blockage of either nostril, deviated septum, structural or anatomical nasal conditions or nasal surgery in the last 6 months. Use of topical nasal medications (e.g., acute or chronic use of prescription or over the counter nasal sprays) that may affect the administration or absorption of the study drug.
Use of 5HT3 antagonists, drugs known to prolong QTc, and use of antihypertensives.
The participant has a medical history of or a positive blood test for human immunodeficiency virus (HIV: HIV, anti-HIV1 and anti-HIV2 antibodies), hepatitis C virus (HCV, anti-HCV antibodies), or hepatitis B surface antigen (HBsAg) at screening.

Show all 23Show fewer

Aspartate transaminase (AST), alanine transaminase (ALT), gamma-glutamyl transferase (GGT), serum creatine, or total bilirubin >1.5x the upper limit of normal (ULN). These laboratory tests may be repeated once if they are abnormal on first screening, and if there is a medical reason to believe the results may be inaccurate. If the repeat test is within the normal range, the participant may be included in the study only if the Investigator (or qualified designee) considers that the previous finding will not compromise the participant's safety and will not interfere with the interpretation of safety data.
A positive drug or alcohol screen. A positive drug or alcohol screen test result may be verified by re-testing at the discretion of the Investigator (or qualified designee), with up to 1 false positive result permitted.
History of regular alcohol consumption within 6 months of screening defined as an average weekly intake of >21 units. One unit is equivalent to 10 g of alcohol and the following can be used as a guide: a half-pint (~240 mL) of beer, 1 glass (125 mL) of wine or 1 (30 mL) measure of spirits.
The participant is unwilling to abstain from alcohol consumption from 24 h prior to treatment with any study intervention (including domperidone) and until discharge from the CRU, and for 24 h prior to all other outpatient visits to the CRU.
The participant is pregnant or planning to become pregnant within 90 days of the study or is breastfeeding.
Major surgery within 4 weeks of screening 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 participant in the opinion of the Investigator (or qualified designee).
Use of tobacco or nicotine products exceeding 5 cigarettes (or equivalent) per week in any form within 30 days prior to treatment with any study intervention (including domperidone), or unwillingness to refrain from smoking, vaping, or using any nicotine products for at least 48 h prior to dosing with any study intervention (including domperidone), the confinement period, and any follow up visits.
The participant uses or is planning to use any prescription or non-prescription medications (with the exception of hormonal contraceptives), herbal and dietary supplements, within 5 days or 5 half-lives (whichever is longer) prior to treatment with any study intervention (including domperidone), unless in the opinion of the PI, local MM and Sponsor medical representative, the medication is not expected to interfere with the study procedures or compromise participant safety
Participation in a clinical trial and receipt of an investigational medication within 90 days, 5 half-lives (if known) or twice the duration of the biological effect of any medication, whichever is longer, prior to the first dose of study intervention.
Use of any strong CYP450-3A4/5 inhibiting or inducing agents within 14 days of dosing with any study intervention (including domperidone) and for the duration of the study.
Consumption of grapefruit, grapefruit juice, star fruit, oranges, orange juice, Seville oranges, within 14 days prior to dosing with any study intervention (including domperidone) and participant is unwilling to abstain from consumption of these products until after discharge from the CRU.
Participant is unwilling to abstain from the consumption of caffeine and/or xanthine containing products (e.g., coffee, tea, chocolate, and caffeine containing sodas, etc.) from time of admission to the CRU on Day -1 until after discharge from the CRU.
Known sensitivity to any study intervention, including NT-301, apomorphine HCl and domperidone.
Loss or donation of whole blood (>499 mL) within 3 months and/or plasma donation within 2 weeks, prior to dosing with any study intervention (including domperidone), or intention to donate blood or blood products during the study.
The participant has a history of cancer, with the exception of basal cell carcinoma or in situ cervical cancer that has been in remission for ≥5 years prior to first dose of study treatment.
Participants with a pre-disposition to nausea and vomiting (e.g., history of severe travel sickness).
The participant is unwilling or unable to follow protocol requirements, including domperidone self-administration and diary completion, and attendance at follow up visit(s), or otherwise unsuitable for study participation in the opinion of the Investigator.

Trial locations and contacts

2 sites in 1 country.

Australia2 sites

CMAX Clinical Research Center Pty Limited
Adelaide, South Australia, 5000
CMAX
Adelaide, South Australia

Other trials in Australia

About this study

Official title: A Phase 1, Two-Part Study of Nasal NT-301 Safety, Tolerability, and Pharmacokinetics in Healthy Volunteers: a Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Investigation Followed by an Open-Label, Two-Way, Two-Period, Crossover Evaluation of NT-301 Bioavailability Compared to Subcutaneous Apomorphine

The purpose of this research project is to investigate the safety and tolerability of an approved drug (Apomorphine) when administered as a nasal powder spray formulation (NT-301) as well as collect information on how NT-301 moves into, through and out of your body, called Pharmacokinetics. The study also aims to compare the safety, tolerability and pharmacokinetics of NT-301 to an injectable Apomorphine product (Movapo Pen), already approved for use in Australia.

Read the detailed description

The study will be conducted in two parts:

Part 1: Single Ascending Dose (SAD)- 4 groups will receive a single dose only. Each group receiving a dose higher than the previous cohort. Some participants will get a nasal spray containing NT-301 and others will get a placebo.

Part 2: Comparison PK study- 2 groups to receive 1 dose of NT-301 and a second single dose of approved medication (Apomorphine injection).

Conditions: Tolerability of NT-301 Nasal Spray, Pharmacokinetics of NT-301 Nasal Spray, Safety of NT-301 Nasal Spray, Performance of NT-301 Nasal Spray Device
Being tested: NT-301 1 mg, NT-301 2 mg, Placebo 1 mg, Placebo 2 mg, Placebo 3 mg
Keywords: Safety, NT-301, tolerability, pharmacokinetics, performance of device

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NT-301 1 mgCombination product
unidose of 1 mg apomorphine through nasal spray
NT-301 2 mgCombination product
unidose of 2 mg apomorphine through nasal spray
Placebo 1 mgCombination product
Matching Placebo to NT-301 1 mg
Placebo 2 mgCombination product
Matching Placebo to NT-301 2 mg
Placebo 3 mgCombination product
Matching Placebo to NT-301 3 mg
NT-301 3 mgCombination product
unidose apomorphine nasal spray 3 mg
NT-301 4 mgCombination product
unidose apomorphine nasal spray 4 mg
Placebo 4 mgCombination product
Matching placebo to NT-301 4 mg
Active Comparator: Movapo penDrug
Approved drug in Australia
Experimental: BA NT-301 strength 4 mgDrug
Combination Product: NT-301 apomorphine nasal spray strength 4 mg given by 2 mg on each nostril (2x2 mg)

Study groups in NCT06954428
Study group	Role	What they receive
Placebo 1 mg	Placebo comparator	Matching Placebo for 1 mg NT-301 Receives: Combination Product: NT-301 1 mg; Combination Product: Placebo 1 mg
Placebo 2 mg	Placebo comparator	Matching placebo for NT-301 2 mg strength Receives: Combination Product: NT-301 2 mg; Combination Product: Placebo 2 mg
NT-301 1 mg	Experimental	NT-301 nasal spray 1 mg strength Receives: Combination Product: NT-301 1 mg
NT-301 2 mg	Experimental	NT-301 nasal spray 2 mg strength Receives: Combination Product: NT-301 2 mg
Placebo 3 mg	Placebo comparator	Matching placebo for NT-301 3 mg Receives: Combination Product: Placebo 3 mg
placebo 4 mg	Placebo comparator	Matching placebo for NT-301 4 mg Receives: Combination Product: Placebo 4 mg
NT-301 3 mg	Active comparator	Apomorphine nasal spray 3 mg Receives: Combination Product: NT-301 3 mg
NT-301 4 mg	Experimental	apomorphine nasal spray 4 mg Receives: Combination Product: NT-301 4 mg
BA NT-301 strength 4 mg	Experimental	NT-301 apomorphine nasal spray strength 4 mg Receives: Drug: Active Comparator: Movapo pen
Active Comparator: BA Movapo pen	Experimental	Apomorphine 2 mg sc injection Receives: Drug: Experimental: BA NT-301 strength 4 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety of NT-301
Laboratory safety data
Measured: Enrollment to 7 days after dosing
Tolerability of NT-301
Nasal examinations by the Quantitative Scoring Scale - Nasal Mucosa (QSS-NM): range 0 to 34.
Measured: Enrollment to 7 day post dose

Secondary outcomes (3)

Pharmacokinetics of Apomorphine
Cmax (ng/mL)
Measured: Predosing to 24 hours post dosing
Pharmacokinetics of Apomorphine
Area under curve (AUC): ng*hr/mL
Measured: Predose to 24 hour post dose
Pharmacokinetics of Apomorphine
Tmax: in hour
Measured: Predose to 24 hour post dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jun 202512 Dec 2025

First posted1 May 2025
Study start20 Jun 2025
Primary completion12 Dec 2025
Study completion12 Dec 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Tolerability of NT-301 Nasal SprayStudies 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: Sequential
Model description: Single ascending dose trial in the first part (4 cohorts) and cross-over trial of one of the dose against the comparator drug.
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 49 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06954428
Sponsor's protocol ID: NT-301-101
Acronym: APPROVE
Status last verified: Feb 2026
First submitted: 7 Mar 2025
Last updated: 19 Feb 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: Yes
Individual data sharing: Undecided

Study at a glance

From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Two-Part Study of Nasal NT-301 Safety, Tolerability, and Pharmacokinetics in Healthy Volunteers: a Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Investigation Followed by an Open-Label, Two-Way, Two-Period, Crossover Evaluation of NT-301 Bioavailability Compared to Subcutaneous Apomorphine
ClinicalTrials.gov ID: NCT06954428
Acronym / sponsor ID: APPROVE / NT-301-101
Conditions: Tolerability of NT-301 Nasal Spray, Pharmacokinetics of NT-301 Nasal Spray, Safety of NT-301 Nasal Spray, Performance of NT-301 Nasal Spray Device
Keywords: Safety, NT-301, tolerability, pharmacokinetics, performance of device
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 49 participants (actual)
Lead sponsor: Nano PharmaSolutions AustraliaIndustry (pharma, biotech, devices)
Collaborators: CMAX Clinical Research Pty Limited, Beyond Drug Development
Study start: 20 Jun 2025 (actual)
Primary completion: 12 Dec 2025 (actual)
Study completion: 12 Dec 2025 (actual)
First posted: 1 May 2025 (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.

Detailed description

The study will be conducted in two parts:

Part 2: Comparison PK study- 2 groups to receive 1 dose of NT-301 and a second single dose of approved medication (Apomorphine injection).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 10
Model description: Single ascending dose trial in the first part (4 cohorts) and cross-over trial of one of the dose against the comparator drug.

Arm	Type	Receives
Placebo 1 mg	Placebo comparator	Combination Product: NT-301 1 mg, Combination Product: Placebo 1 mgMatching Placebo for 1 mg NT-301
Placebo 2 mg	Placebo comparator	Combination Product: NT-301 2 mg, Combination Product: Placebo 2 mgMatching placebo for NT-301 2 mg strength
NT-301 1 mg	Experimental	Combination Product: NT-301 1 mgNT-301 nasal spray 1 mg strength
NT-301 2 mg	Experimental	Combination Product: NT-301 2 mgNT-301 nasal spray 2 mg strength
Placebo 3 mg	Placebo comparator	Combination Product: Placebo 3 mgMatching placebo for NT-301 3 mg
placebo 4 mg	Placebo comparator	Combination Product: Placebo 4 mgMatching placebo for NT-301 4 mg
NT-301 3 mg	Active comparator	Combination Product: NT-301 3 mgApomorphine nasal spray 3 mg
NT-301 4 mg	Experimental	Combination Product: NT-301 4 mgapomorphine nasal spray 4 mg
BA NT-301 strength 4 mg	Experimental	Drug: Active Comparator: Movapo penNT-301 apomorphine nasal spray strength 4 mg
Active Comparator: BA Movapo pen	Experimental	Drug: Experimental: BA NT-301 strength 4 mgApomorphine 2 mg sc injection

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (15 listed)

Male or female participants aged between 18 and 60 years of age, inclusive at the time of signing the informed consent document.
Body weight ≥50 kg and body mass index (BMI) within the range of 18 to 32 kg/m2 inclusive at screening.
Woman of childbearing potential (WOCBP) or fertile male participants must agree to use an acceptable method of contraception from the start of Screening until 90 days (male participants) or 60 days (female participants) after the final study visit.
WOCBP must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to administration of the first dose of study intervention (including domperidone) and be willing to have additional pregnancy tests, as required, throughout the study.
Participants must be in good general health, as demonstrated at screening and prior to first administration of any study intervention (including domperidone) by the absence of clinically significant (in the opinion of the Investigator) abnormalities based on a medical evaluation including review of medical history, physical examination, safety laboratory tests, vital signs, 12-lead ECG monitoring.

Key exclusion criteria (23 listed)

Any significant medical condition, physical or psychiatric illness or history of depression that could, in the Investigator's (or qualified designee) opinion, compromise the participant's safety or interfere with the completion of this study.
History of clinically significant CNS, cardiac, pulmonary, metabolic, renal, hepatic, or gastrointestinal (GI) conditions including gastric bypass or other weight loss surgical procedure.
Any condition including the presence of laboratory abnormalities, which according to the Investigator (or qualified designee), places the participant at unacceptable risk if they were to participate in the study or may confound the ability to interpret data from the study. This includes the presence of uncontrolled current illness (e.g., an infection), a viral infection, seasonal allergy, or concurrent skin rash.
Any nasal condition, including nasal congestion, physical blockage of either nostril, deviated septum, structural or anatomical nasal conditions or nasal surgery in the last 6 months. Use of topical nasal medications (e.g., acute or chronic use of prescription or over the counter nasal sprays) that may affect the administration or absorption of the study drug.
Use of 5HT3 antagonists, drugs known to prolong QTc, and use of antihypertensives.

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
NT-301 1 mgunidose of 1 mg apomorphine through nasal spray	Combination product	NT-301 1 mg, Placebo 1 mg
NT-301 2 mgunidose of 2 mg apomorphine through nasal spray	Combination product	NT-301 2 mg, Placebo 2 mg
Placebo 1 mgMatching Placebo to NT-301 1 mg	Combination product	Placebo 1 mg
Placebo 2 mgMatching Placebo to NT-301 2 mg	Combination product	Placebo 2 mg
Placebo 3 mgMatching Placebo to NT-301 3 mg	Combination product	Placebo 3 mg
NT-301 3 mgunidose apomorphine nasal spray 3 mg	Combination product	NT-301 3 mg
NT-301 4 mgunidose apomorphine nasal spray 4 mg	Combination product	NT-301 4 mg
Placebo 4 mgMatching placebo to NT-301 4 mg	Combination product	placebo 4 mg
Active Comparator: Movapo penApproved drug in Australia	Drug	BA NT-301 strength 4 mg
Experimental: BA NT-301 strength 4 mgCombination Product: NT-301 apomorphine nasal spray strength 4 mg given by 2 mg on each nostril (2x2 mg)	Drug	Active Comparator: BA Movapo pen

Primary outcome

Safety of NT-301
Time frame: Enrollment to 7 days after dosing
Laboratory safety data
Tolerability of NT-301
Time frame: Enrollment to 7 day post dose
Nasal examinations by the Quantitative Scoring Scale - Nasal Mucosa (QSS-NM): range 0 to 34.

3 secondary outcomes

Pharmacokinetics of Apomorphine
Time frame: Predosing to 24 hours post dosing
Pharmacokinetics of Apomorphine
Time frame: Predose to 24 hour post dose
Pharmacokinetics of Apomorphine
Time frame: Predose to 24 hour post dose

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 19 Feb 2026.
Individual participant dataSharing planned: Undecided

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.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 15 inclusion and 23 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 19 Feb 2026. 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. Some participants in this study may receive a placebo. 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 of NT-301 (time frame: Enrollment to 7 days after dosing). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06954428.

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 19 Feb 2026.