Clinical Trial of Intranasal Delivery of NT-301

NCT06954428 | Completed Phase 1 DMC FDA Drug FDA Device

• 1 other identifier: NT-301-101
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 2

Brief Summary

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.

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

Outcome Measures

Primary Outcomes (2)

• Safety of NT-301

  Laboratory safety data

  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.

  Enrollment to 7 day post dose

Secondary Outcomes (3)

• Pharmacokinetics of Apomorphine

  Predosing to 24 hours post dosing

• Pharmacokinetics of Apomorphine

  Predose to 24 hour post dose

• Pharmacokinetics of Apomorphine

  Predose to 24 hour post dose

Study Arms (10)

Placebo 1 mg

PLACEBO COMPARATOR

Matching Placebo for 1 mg NT-301

Combination Product: NT-301 1 mg; Combination Product: Placebo 1 mg

Placebo 2 mg

PLACEBO COMPARATOR

Matching placebo for NT-301 2 mg strength

Combination Product: NT-301 2 mg; Combination Product: Placebo 2 mg

NT-301 1 mg

EXPERIMENTAL

NT-301 nasal spray 1 mg strength

Combination Product: NT-301 1 mg

NT-301 2 mg

EXPERIMENTAL

NT-301 nasal spray 2 mg strength

Combination Product: NT-301 2 mg

Placebo 3 mg

PLACEBO COMPARATOR

Matching placebo for NT-301 3 mg

Combination Product: Placebo 3 mg

placebo 4 mg

PLACEBO COMPARATOR

Matching placebo for NT-301 4 mg

Combination Product: Placebo 4 mg

NT-301 3 mg

ACTIVE COMPARATOR

Apomorphine nasal spray 3 mg

Combination Product: NT-301 3 mg

NT-301 4 mg

EXPERIMENTAL

apomorphine nasal spray 4 mg

Combination Product: NT-301 4 mg

BA NT-301 strength 4 mg

EXPERIMENTAL

NT-301 apomorphine nasal spray strength 4 mg

Drug: Active Comparator: Movapo pen

Active Comparator: BA Movapo pen

EXPERIMENTAL

Apomorphine 2 mg sc injection

Drug: Experimental: BA NT-301 strength 4 mg

Interventions

Active Comparator: Movapo pen DRUG

Approved drug in Australia

BA NT-301 strength 4 mg

Experimental: BA NT-301 strength 4 mg DRUG

Combination Product: NT-301 apomorphine nasal spray strength 4 mg given by 2 mg on each nostril (2x2 mg)

Active Comparator: BA Movapo pen

NT-301 1 mg COMBINATION_PRODUCT

unidose of 1 mg apomorphine through nasal spray

NT-301 1 mg; Placebo 1 mg

NT-301 2 mg COMBINATION_PRODUCT

unidose of 2 mg apomorphine through nasal spray

NT-301 2 mg; Placebo 2 mg

Placebo 1 mg COMBINATION_PRODUCT

Matching Placebo to NT-301 1 mg

Placebo 1 mg

Placebo 2 mg COMBINATION_PRODUCT

Matching Placebo to NT-301 2 mg

Placebo 2 mg

Placebo 3 mg COMBINATION_PRODUCT

Matching Placebo to NT-301 3 mg

Placebo 3 mg

NT-301 3 mg COMBINATION_PRODUCT

unidose apomorphine nasal spray 3 mg

NT-301 3 mg

NT-301 4 mg COMBINATION_PRODUCT

unidose apomorphine nasal spray 4 mg

NT-301 4 mg

Placebo 4 mg COMBINATION_PRODUCT

Matching placebo to NT-301 4 mg

placebo 4 mg

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• CMAX Clinical Research Pty Limited: collaborator
• Beyond Drug Development: collaborator
• Nano PharmaSolutions Australia: lead

Study Sites (2)

CMAX Clinical Research Center Pty Limited

Adelaide, South Australia, 5000, Australia

Location

CMAX

Adelaide, South Australia, Australia

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Blinded CRO project manager and medical affairs professional
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single ascending dose trial in the first part (4 cohorts) and cross-over trial of one of the dose against the comparator drug.

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: May 1, 2025
• Study Start: June 20, 2025
• Primary Completion: December 12, 2025
• Study Completion: December 12, 2025
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

AU (2)