Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05026008




Registration number
NCT05026008
Ethics application status
Date submitted
18/08/2021
Date registered
30/08/2021
Date last updated
22/11/2023

Titles & IDs
Public title
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SR1375
Scientific title
A Randomized, Double-blind, Placebo-controlled, 2-part Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of SR1375 in Healthy Volunteers
Secondary ID [1] 0 0
SR1375-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SR1375
Treatment: Drugs - Matching placebo

Experimental: SR1375 Capsule - Ascending single and multiple doses of SR1375 capsules orally

Experimental: Matching placebo - Ascending single and multiple doses of placebo capsules orally


Treatment: Drugs: SR1375
The subject will be orally administered by single and multiple doses of SR1375 capsules with 240 ml water

Treatment: Drugs: Matching placebo
The subject will be orally administered by single and multiple doses of matching capsules with 240 ml water
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
AE (Adverse Event)
Timepoint [1] 0 0
Up to Day 32
Secondary outcome [1] 0 0
Plasma PK : Tmax
Timepoint [1] 0 0
Up to Day 32
Secondary outcome [2] 0 0
Plasma PK : Ctrough
Timepoint [2] 0 0
Up to Day 32
Secondary outcome [3] 0 0
Plasma PK : AUC0-t
Timepoint [3] 0 0
Up to Day 32
Secondary outcome [4] 0 0
Plasma PK : AUC0-8
Timepoint [4] 0 0
Up to Day 32
Secondary outcome [5] 0 0
Urine PK: Ae
Timepoint [5] 0 0
Up to Day 4
Secondary outcome [6] 0 0
Urine PK: CLr
Timepoint [6] 0 0
Up to Day 4

Eligibility
Key inclusion criteria
Healthy volunteers will be included in the study if they satisfy all the following
criteria:

1. Must have given written informed consent before any study-related activities are
carried out and must be able to understand the full nature and purpose of the trial,
including possible risks and adverse effects.

2. Adult males (for both SAD and MAD stage) and female (only for MAD stage), 18 to 55
years of age (inclusive) at screening.

3. Body mass index (BMI) = 18 and = 32 kg/m2, with a body weight = 50 kg at screening.

4. Use of tobacco or nicotine-containing products:

5. Medically healthy without clinically significant abnormalities at the screening visit,
at check-in on Day -1 and pre-dose on Day 1.

6. Conventional 12-lead ECG recording in triplicate (the mean of triplicate measurements
will be used to determine eligibility at the screening visit, on Day -1 and pre-dose
on Day 1) consistent with normal cardiac conduction and function.

7. Have suitable venous access for blood sampling.

8. Be willing and able to comply with all study assessments and adhere to the protocol
schedule and restrictions.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Volunteers will be excluded from the study if there is evidence of any of the following:

1. History or presence of significant cardiovascular, pulmonary, hepatic, renal,
haematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological
disease, including any acute illness or major surgery within the past three months
determined by the Investigator to be clinically relevant.

2. Any history of malignant disease in the last 10 years (excluding completely treated
cutaneous squamous cell or basal cell carcinoma).

3. Liver function test results (i.e., aspartate aminotransferase [AST], alanine
aminotransferase [ALT], and gamma glutamyl transferase [GGT]) and bilirubin (total,
conjugated and unconjugated) elevated more than 1.5-fold above the upper limit of
normal (ULN).

4. Positive test results for active human immunodeficiency virus (HIV-1 and HIV-2),
hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies at the
screening visit.

5. Presence or having sequelae of gastrointestinal, liver (including Gilbert's syndrome),
kidney, or other conditions known to interfere with the absorption, distribution,
metabolism, or excretion of drugs. Exception: cholecystectomy is allowed.

6. History of substance abuse or alcohol abuse defined as >21 units of alcohol per week
for males and >14 units of alcohol per week for females (for MAD cohorts only). One
unit is equivalent to 8 g of alcohol: a half-pint (~285 mL) of beer, 1 glass (125 mL)
of wine or 1 measure (25 mL) of spirits.

7. Is an employee of an Investigator or Sponsor or an immediate relative of an
Investigator.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/09/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/03/2023
Sample size
Target
Accrual to date
Final
72
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Linear Clinical Research Ltd - Nedlands
Recruitment postcode(s) [1] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
SIMR (Australia) Biotech Pty Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a randomized, double-blind, placebo-controlled, 2-part study to evaluate the safety,
tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of
SR1375 in healthy volunteers
Trial website
https://clinicaltrials.gov/ct2/show/NCT05026008
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Redfern
Address 0 0
Linear Clinical Research
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05026008