Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001065381
Ethics application status
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Approved
Date submitted
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5/08/2026
Date registered
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28/08/2026
Date last updated
Help: Date last updated
22/09/2026
Date data sharing statement initially provided
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28/08/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
An Intravenous versus Oral Crossover study to assess safety, bioavailability and pharmacokinetics of investigational product RLS-2202 in healthy adults compared to oral Seroquel
Scientific title
A Phase 1a, Open-Label, 2-Period, Single-Dose Crossover Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of RLS-2202, an Intra venous (IV) formulation of Quetiapine, Following IV and Oral Administration in Healthy
Adult Volunteers
Additional trial identifiers [1] 318238 0
NIL
Universal Trial Number (UTN)
Trial acronym
PAB-2202-001
Related trial records

Health condition
Health condition(s) studied:
Delirium 342873 0
Acute agitation 343292 0
Condition category
Condition code
Neurological 338988 338988 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
This clinical trial is designed as an open-label, 2-cohort, single-dose crossover study in healthy adults volunteers, aged 18-65 years old. The investigational product is RLS-2202, a intra-venous (I.V) Quetiapine Fumarate formulation and will be compared to oral SEROQUEL®, Quetiapine Fumarate, which is commercially available, via prescription.

The study consists of two cohorts:
Cohort 1 is the exploratory PK and IV dose characterisation, where 4 healthy volunteers will receive a single dose of 25mg oral SEROQUEL® on Day 1, Period 1. Blood sampling over an 8 hour period at pre-dose, 1-2, 10, 30, 60, 90mins, then at 2, 4 and 8 hour will occur to analyse the pharmacokinetics of oral SEROQUEL®. Safety assessments will be performed throughout the 8 hours to ensure wellbeing of volunteers, prior to departing the clinical trial unit. Volunteers will then undergo a washout period of 96 hours before returning to the clinical trial unit for Day 5, Period 2 to receive a single dose of the investigational product, Intra venous RLS-2202, 1mg will be dosed over 1-2 minutes. Blood sampling over an 8 hours period at pre-dose, 1-2, 10, 30, 60, 90mins, then at 2, 4 and 8 hour timepoints to analyse the pharmacokinetics of I.V formulation RLS-2202. Safety assessments will be performed throughout the 8 hours to ensure wellbeing of volunteers, prior to departing the clinical trial unit.

Cohort 2 will consist of 12 healthy adult volunteers who will be admitted to clinic on Day -1 and discharged at Day 7. The volunteers will dosed with IV RLS-2202 at a dose that will be determined by the Safety Review Committee analysis and review of PK data from cohort 1. The Cohort 2 IV dose will not exceed 10mg of RLS-2202. Cohort 2 study design is to determine PK and safety for the determined dose. A single dose will be administered, via I.V. and PK sampling will be conducted over timepoints pre-dose, 1-2mins, 15,20,30 minutes, then at 1,2,4,8,12,24,36 and 48 hours. Safety assessments will also be conducted during this period. The volunteers undergo a washout of 96 hours where a 50mg oral dose of SEROQUEL® will be administered at Day 5. PK sampling will be conducted over a timepoints pre-dose, 15,30,60,90 minutes, 2,3,4,12,24 and 48 hours. Safety assessments will also be conducted during this period. Safety assessments will be performed throughout the confinement period to ensure wellbeing of volunteers and prior to departing the clinical trial unit.
Intervention code [1] 334796 0
Treatment: Drugs
Intervention code [2] 335191 0
Treatment: Other
Intervention code [3] 335192 0
Other interventions
Description of the comparator or control
The comparator for this trial is SEROQUEL®, Quetiapine Fumarate 25mg tablets. This drug is the nominated Reference Listed Drug. For Cohort 1, a 25mg tablet will be taken orally at Day 1. For Cohort 2, two 25mg tablets will be taken orally, on Day 5, for a total of 50mg. This dosing will be conducted during confinement and under supervision.
Control group
Dose comparison

Outcomes
Primary outcome [1] 346248 0
Cohort 1: To assess the Cmax and AUC0-8 of a conservatively estimated IV QTP (Quetiapine fumarate, RLS-2202) dose compared to oral 25 mg of RLD (Reference listed drug Seroquel®), to identify the IV dose most closely matching oral 50 mg systemic exposure.
Timepoint [1] 346248 0
The Cohort 1 timepoints are Pre-dose, 10, 20,30,60, 90 minutes then at 2, 4 and 8 hours. The Cohort 2 timepoints are Pre-dose, 10, 20,30,60 minutes then at 2, 4, 8, 12, 24, 36, 48 and 96 hours.
Primary outcome [2] 346249 0
Cohort 2: To characterise the pharmacokinetic profile of the selected IV dose of RLS-2202 following a single dose administration relative to that of an oral dose of 50mg Quetiapine, used in clinical practice.
Timepoint [2] 346249 0
Pre-dose, 15, 20, 30minutes, then at 1,2,4,8,12,24,36,48 hours for IV dose of RLS-2202 (Dose determined by analysis post Cohort 1) Pre-dose, 15,30,60,90 minutes, then at 2,3,4,8,12,24,36 and 48 hours for oral dose of 50mg Quetiapine Fumarate (Seroquel)
Secondary outcome [1] 465213 0
To evaluate the safety and tolerability of RLS-2202 after a single IV administration and this will be assessed as a composite outcome
Timepoint [1] 465213 0
Cohort 1: Adverse Events (AEs), including Serious Adverse Events, (SAEs), Adverse Events of Special Interest (AESIs), and Suspected Unexpected Serious Adverse Reactions (SUSARs) will be collected from Day -1 to 8 hours post dose for Cohort 1. Cohort 2: Adverse Events (AEs), including Serious Adverse Events, (SAEs), Adverse Events of Special Interest (AESIs), and Suspected Unexpected Serious Adverse Reactions (SUSARs) will be collected from Day -1 to Day 7 post dose for Cohort 2. The ECG parameters being assessed include heart rate, PR interval, QRS duration, QT interval, QTcB, and QTcF. Performed after =10 minutes of supine rest. Vital sign assessments include Tympanic temperature, heart rate, respiratory rate, systolic and diastolic blood pressure (BP). Blood pressure and heart rate will be measured after a minimum of 5 minutes of supine rest using a validated, calibrated oscillometric device. At the Screening visit, BP will be measured in triplicate, with readings taken at least 1 minute apart; the average of the three measurements will be recorded. At all other timepoints, a single BP and heart measurement will be obtained, with repeat assessment performed if results are outside acceptable ranges or clinically abnormal. Respiratory rate and tympanic temperature will be recorded at each scheduled timepoint. Orthostatic vital signs (supine-to-standing BP and heart rate) will be assessed at screening, pre-dose, 60 mins, 90, mins, and 2 hours post-dose, or at any other time point if clinically indicated and at the investigator discretion, after at least 2 minutes of standing. Acceptable ranges for vital signs are as follows: Temperature: 35.5°C to 37.7°C Heart rate: 45 to 100 bpm Respiratory rate: 12 to 22 breaths per minute Systolic BP: 90 to 160 mmHg Diastolic BP: 50 to 95 mmHg Predefined stopping thresholds are as follows: systolic BP 180 mmHg, and diastolic BP 110 mmHg. The clinical laboratory parameters consist of the following; Drugs and Alcohol Screen (Urine drug screen for Amphetamine, Barbiturates, Benzodiazepines, Cocaine, THC, Methadone, Methamphetamine, Opiates, Phencyclidine, Tricyclic Antidepressants, Alcohol breath test). Biochemistry (AST, ALT, ALP, albumin, corrected calcium, chloride, creatinine, direct bilirubin, total bilirubin, urea, total protein, phosphate, potassium, random glucose, sodium, TSH). Haematology (Haemoglobin, haematocrit, WBC (with differential: neutrophils, lymphocytes, monocytes, eosinophils, basophils), RBC, platelet). Urinalysis (Bilirubin, blood, glucose, ketones, leucocyte esterase, creatinine, phosphate, nitrites, specific gravity, pH, protein, urobilinogen. Note: Microscopic examination (if blood or protein is abnormal), Blood or leukocyte esterase only). Serology Test (HIV, Hepatitis B and Hepatitis C).

Eligibility
Key inclusion criteria
Participants who meet all of the following criteria will be eligible to participate:
1) Must be able to provide written, personally signed and dated informed consent to participate in the study before completing any study related procedures.
2) Male or female aged 18 to 65 years, inclusive, at the time of consent.
3) Body mass index (BMI) greater or equal to 18.0 to less than or equal to 30.0 kg per m² with a body weight greater or equal to 50 kg.
4) Nonsmokers or light tobacco/nicotine user (e.g., smokers, electronic cigarettes, vaping, and smokeless tobacco/nicotine products limited to 5 cigarette equivalents per week in last month), that are willing to abstain from nicotine use throughout the study (Day-1 through End of Study).
5) No Clinically significant abnormalities as determined by the Principal Investigator or delegate based on review of medical history, physical examination, ECG, vital signs (including blood pressure and heart rate) and clinical laboratory tests.
6) Females of childbearing potential must agree to use a highly effective method of contraception from the time of consent through to at least 30 days after the last dose of the study drug. Highly effective methods of contraception include established use of a intrauterine device, intrauterine system, contraceptive implant, combined injectable contraceptives, hormonal oral contraceptives when used in combination with male condoms. Sexual abstinence, defined as refraining from heterosexual intercourse, when this is in line with the preferred and usual lifestyle of the participant. Female participants with male partner(s) must utilize highly effective forms of contraception and their male partner(s) must use a male condom. Female of childbearing potential should refrain from donating ova for 30 days after the last dose of study medication.
7) Females of nonchildbearing potential must be postmenopausal (defined as a minimum of 12 consecutive months of spontaneous amenorrhea and / or FSH greater than 40.0 IU/L) or surgically sterile (hysterectomy, bilateral oophorectomy, bilateral salpingectomy, bilateral tubal ligation or bilateral tubal occlusion). Females of nonchildbearing potential are exempt from contraception requirements.
8) Male participants are eligible to participate if they are: Permanently sterile (via a vasectomy performed at least 3 months prior to Screening with documented confirmation of azoospermia, or due to a medical condition); OR
Are non-sterile but agree to use a male condom (barrier contraception) during the study and for at least 90 days after the final dose of the study drug, and their female partner of childbearing potential agrees to use a highly effective method of contraception.

All male participants must refrain from donating sperm during this period.
9) Must not take any prescription with the exception of contraceptives, HRT, or over the counter pain medications during the study unless otherwise approved by the Principal Investigator or delegate.
10) Participants may be included if they have a history of the following conditions, provided they are clinically stable and, in the opinion of the investigator, do not pose an increased risk or interfere with study participation or interpretation of results:
- Prior cholecystectomy (gallbladder removal)
- Gilbert’s syndrome, provided there is no evidence of clinically significant liver dysfunction beyond benign unconjugated hyperbilirubinemia
- History of childhood asthma that is no longer active or requires no ongoing treatment
- History of depression that is stable, adequately managed, and does not interfere with compliance with study procedures

Individuals with these conditions may be enrolled at the principal investigator or delegate’s discretion, provided all other inclusion and exclusion criteria are met.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
Any of the following medical conditions:
a. Any significant acute illness within 30 days prior to Screening which, in the opinion of the Principal Investigator or delegate and / or study Medical Monitor, could interfere with the participant's safety or study objectives.
b. History of hypotension (systolic BP < 95) or orthostatic hypotension (systolic BP less than 90, or a greater than 20mmHg fall in systolic BP on standing) at screening, OR in the morning prior to dosing
c. Positive tests at Screening for HIV, hepatitis B or hepatitis C.
d. Previous malignant disease (except basal cell carcinoma of skin and cervical
carcinoma in situ/dysplasia).
2) Must not have a history of organic heart disease including coronary artery disease, myocardial infarction, angina, clinically significant abnormal ECGs, QTcF interval greater than 450 msec for males and grater than 470 msec for females, congestive heart failure, valvular heart disease and congenital heart disease.
3) Use of concomitant medications that prolong the QT/QTc interval or triptan medications
for migraine headaches within 28 days before dosing.
4) Must not have a history of excessive alcohol use (on average more than 14 standard drinks per week), or any other substance use disorder (excluding nicotine) currently or within 1 year prior to enrolment based on the discretion of the investigator.
5) Must not test positive for a substance of abuse or have a positive alcohol breath test at the time of screening or check in. Re-tests will not be allowed for a positive screen of an illicit drug or alcohol.
6) Positive pregnancy test at screening or check in or is breastfeeding/lactating.
7) Symptoms or history suggestive of a recent systemic illness or febrile illness within 7 days prior to check in based on the Principal Investigator or delegate’s discretion. Participants with a positive test for flu, or other viral infections may isolate and be rescreened for the study.
8) Cannot tolerate venipuncture, has poor venous access that would cause difficulty for collecting blood samples and absence of tattoos at intended injection site that in the opinion of the Investigator would obscure the evaluation of local injection site reactions.
9) Use of any prescription medication (excluding contraceptives) within 14 days or 5 half-lives (whichever is longer) prior to first dose.
10) Use of over-the-counter medications, herbal and nutritional supplements including St. John’s Wort within 14 days or 5 half-lives (whichever is longer) prior to first dose.
11) Use of CYP450 3A inhibitors or inducers within 28 days before dosing.
12) Donation of greater than 450 mL blood within 3 months, or plasma and platelet donation within 6 weeks, prior to first dose.
13) Hypersensitivity or contraindication to QTP or any excipient of the IV or oral
formulations.
14) Has taken other investigational drug or participated in any clinical study within 30 days prior to dosing or is currently participating in another clinical study.
15) Clinically significant laboratory (blood or urine) abnormality as defined by the investigator. Liver enzymes (Total Bilirubin, AST/ALT, ALP, GGT) may not be greater than 1.5 times the upper limit of normal (ULN) at baseline (day -1 for Period 1). If values exceed this
threshold, repeat testing may be performed at the discretion of the investigator; eligibility
will be based on the repeat result.
16) Unwilling or unlikely to comply with the requirements of the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/08/2026
Actual
31/08/2026
Date of last participant enrolment
Anticipated
4/11/2026
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
16
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 29954 0
CMAX Clinical Research Pty Ltd - Adelaide
Recruitment postcode(s) [1] 46318 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 322653 0
Commercial sector/Industry
Name [1] 322653 0
Patrys Ltd
Country [1] 322653 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Patrys Ltd
Address
Country
Australia
Secondary sponsor category [1] 325317 0
None
Name [1] 325317 0
Address [1] 325317 0
Country [1] 325317 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320895 0
Bellberry Human Research Ethics Committee F
Ethics committee address [1] 320895 0
Ethics committee country [1] 320895 0
Australia
Date submitted for ethics approval [1] 320895 0
23/06/2026
Approval date [1] 320895 0
27/08/2026
Ethics approval number [1] 320895 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 151994 0
Dr Sepehr Shakib
Address 151994 0
CMAX Clinical Research 21/24 North Terrace, Adelaide, 5000, South Australia
Country 151994 0
Australia
Phone 151994 0
+61 411 100 278
Fax 151994 0
Email 151994 0
[email protected]
Contact person for public queries
Name 151995 0
Dr Samantha South
Address 151995 0
Patrys Ltd. 168 Stirling Highway, Nedlands 6009 Western Australia
Country 151995 0
Australia
Phone 151995 0
+61 421 117 241
Fax 151995 0
Email 151995 0
[email protected]
Contact person for scientific queries
Name 151996 0
Dr Samantha South
Address 151996 0
Patrys Ltd. 168 Stirling Highway, Nedlands 6009 Western Australia
Country 151996 0
Australia
Phone 151996 0
+61 421 117 241
Fax 151996 0
Email 151996 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Not applicable for this study



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.