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Trial registered on ANZCTR

Registration number
Ethics application status
Submitted, not yet approved
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 1 study to evaluate Safety, Tolerability and Pharmacokinetics of LMR-123 in Healthy Subjects
Scientific title
A Phase 1, Randomized, Placebo-controlled Safety, Tolerability and Pharmacokinetic Study of Single Ascending Doses of LMR-123 in Healthy Subjects
Secondary ID [1] 299780 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Ischemic Stroke 315126 0
Condition category
Condition code
Stroke 313446 313446 0 0

Study type
Description of intervention(s) / exposure
Subjects will be administered LMR-123 or matching placebo in cohort 1-6 via intravenous infusion over 30 minutes as below:
• Cohort 1 – 2 mg/kg LMR-123 (n=4), (open label);
• Cohort 2 – 4 mg/kg LMR-123 (n=6), placebo (n=2) (blinded);
• Cohort 3 – 8 mg/kg LMR-123 (n=6), placebo (n=2) (blinded);
• Cohort 4 – 12 mg/kg LMR-123 (n=6), placebo (n=2) (blinded);
• Cohort 5 – 16 mg/kg LMR-123 (n=6), placebo (n=2) (blinded);
• Cohort 6 – 20 mg/kg LMR-123 (n=6), placebo (n=2) (blinded);
Subjects cannot be enrolled in more than one cohort.
Intervention code [1] 316019 0
Treatment: Drugs
Comparator / control treatment
Matching placebo (vehicle lipid emulsion): 10% Soybean Oil, 1.2% Egg Yolk Lecithin, 2.25% Glycerol, appropriate amounts of Sodium Hydroxide, Hydrochloric acid and Water for Injection.
Control group

Primary outcome [1] 321918 0
Evaluate the safety and tolerability of escalating doses of LMR-123 administered as an intravenous injection in healthy subjects compared to placebo.
Timepoint [1] 321918 0
Physical examinations, AEs, vital signs, ECG and clinical laboratory assessments measured throughout the study from screening to End of Study visit to assess any significant changes from baseline results.
Secondary outcome [1] 376709 0
Evaluate Pharmacokinetics of LMR-123 (Cohorts 2-6 only) measuring:
- Area under the serum LMR-123 concentration curve to the last measurable data point;
- Area under the serum LMR-123 concentration curve extrapolated to infinity;
- Peak serum concentration;
- Time to peak serum concentration;
- Elimination half-life;
- Clearance;
- Volume of distribution;
- Individual estimate of the terminal elimination rate constant, calculated using log-linear regression of the terminal portions of the plasma concentration-versus-time curves;
- Mean resistance time.
Timepoint [1] 376709 0
Pharmacokinetic samples are taken during the treatment period for Cohorts 2 - 6; Pre-dose (within 10 minutes), 15, 30, 35, 45 minutes, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 hours on Day 1. 24 hours on Day 2. 48 hours on Day 3 and 72 hours Day 4.
Secondary outcome [2] 376973 0
Identify the structures of LMR-123 metabolites in plasma, urine and fecal samples (subjects in Cohort 4 only)
Timepoint [2] 376973 0
Urine samples are collected at pre-dose (within 2 hours), end of infusion (up to 4 hours), 4-8 hours post-infusion, 8-12 hours post-infusion, 12-48 hours post-infusion, 48-72 hours post-infusion.
Fecal samples are collected pre-dose (within 24 hours) and between 0-72 hours post-infusion.
Plasma samples are collected pre-dose (within 10 minutes), 15, 30, 35, 45 minutes, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72 hours on Day 1. 24 hours on Day 2. 48 hours on Day 3 and 72 hours Day 4.

Key inclusion criteria
1. Male or female healthy subjects, aged 18 to 49 years inclusive;
2. Body mass index of >19.0 kg/m2 to <29.0 kg/m2 at screening;
3. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
• Not of childbearing potential, defined as surgically sterile or postmenopausal.
• Of childbearing potential and agrees to use a highly effective method of contraception consistently during the treatment period and for at least 60 days after the last dose of investigational product;
4. A male subject with a female partner of childbearing potential is eligible to participate if he agrees to use acceptable contraception during the treatment period and for at least 60 days after the last dose of investigational product All male subjects must refrain from donating sperm during the treatment period and for at least 60 days after the last dose of investigational product ;
5. Females of childbearing potential must have a negative pregnancy test at screening (serum) and Day 1 (urine)
6. The subject must voluntarily provide written informed consent prior to any study procedures being performed and is willing and able to comply with procedures required in this protocol.
Minimum age
18 Years
Maximum age
49 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
1. History or evidence of a clinically significant disorder.
2. History significant ophthalmic diseases including but not limited to vitreous opacities, glaucoma, cataract, ophthalmic infection and ophthalmic tumor;
3. History or presence of conditions known to interfere with the distribution, metabolism, or excretion of drugs;
4. Unwillingness to abstain from alcohol from 48 hours prior to investigational product administration.
5. A positive urine drug screen or alcohol breath test at screening;
6. Subjects smokes more than 10 cigarettes per day within 3 months of screening
7. History of surgery or major trauma within 12 weeks of screening, or surgery planned during the study;
8. History of significant neurological diseases, including stroke, transient ischemic attacks, seizures, and vascular malformations;
9. Positive screen for human immunodeficiency virus, hepatitis B virus surface antigen or hepatitis C virus antibody;
10. Treatment with any investigational product within 30 days or 5 half-lives
11. Use of prescription or over the counter medications within 14 days of investigational product administration and during the study, with the exception of contraceptive medications, paracetamol and vitamins;
12. History of cancer,
13. History of allergic reactions
14. Subject has a positive test for tuberculosis (TB) during screening or a known history of active or latent TB
15. Donation or collection of more than or equal to 400 mL of blood for any other purpose within 12 weeks more than or equal to 200 mL within 4 weeks, or donation of blood by apheresis within 2 weeks of the planned first dose.
16. Subject does not agree to avoid food or beverages likely to influence liver metabolism 7 days prior to the first dose of the investigational product until the end of study visit;
17. Subject does not agree to refrain from consuming caffeinated beverages from 48 hours before check-in on Day -1 until completion of the confinement period.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Cohort 1 is open label so randomization is not applicable.
For Cohort 2-6, a computer-generated randomization schedule will be prepared by an unblinded statistician prior to the start of the study. At the time of randomization, the subject will be assigned a unique randomization number, which will be allocated sequentially based on the pre-determined randomization schedule, and according to their chronological order of inclusion in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
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 design features
Phase 1
Type of endpoint(s)
Statistical methods / analysis
The sample size for this study is up to 44 subjects (4 subjects are planned for Cohort 1, and 8 subjects are planned for Cohorts 2 to 6). The sample size for each dose cohort has been selected without performing a formal sample size calculation.
In general, data will be summarized using descriptive statistics (mean, median, standard deviation, minimum and maximum) for continuous variables or using frequency counts and percentages for categorical variables, as appropriate to the type of data.

Recruitment status
Not yet recruiting
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 15130 0
CMAX Clinical Research Pty Ltd - Adelaide
Recruitment postcode(s) [1] 28424 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 304232 0
Commercial sector/Industry
Name [1] 304232 0
Australia Medical Industries Pty Ltd
Address [1] 304232 0
73 Bradman Street
Greystanes, NSW 2145, Australia
Country [1] 304232 0
Primary sponsor type
Commercial sector/Industry
Australia Medical Industries Pty Ltd.
73 Bradman Street
Greystanes, NSW 2145, Australia
Secondary sponsor category [1] 304471 0
Name [1] 304471 0
Address [1] 304471 0
Country [1] 304471 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 304693 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 304693 0
Level 3, Roma Mitchell House
136 North Terrace, ADELAIDE SA 5000
Ethics committee country [1] 304693 0
Date submitted for ethics approval [1] 304693 0
Approval date [1] 304693 0
Ethics approval number [1] 304693 0

Brief summary
This first in human study of LMR-123 will investigate the safety, tolerability and PK of single ascending doses of LMR-123 compared to placebo in healthy subjects.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 97890 0
Prof Guy Ludbrook
Address 97890 0
PARC Clinical Research
Royal Adelaide Hospital
Level 4G.1, East Wing,
Port Road, Adelaide
South Australia, 5000
Country 97890 0
Phone 97890 0
+61 8 7074 1258
Fax 97890 0
+61 8 7074 6146
Email 97890 0
Contact person for public queries
Name 97891 0
Prof Guy Ludbrook
Address 97891 0
PARC Clinical Research
Royal Adelaide Hospital
Level 4G.1, East Wing,
Port Road, Adelaide
South Australia, 5000
Country 97891 0
Phone 97891 0
+61 8 7074 1258
Fax 97891 0
+61 8 7074 6146
Email 97891 0
Contact person for scientific queries
Name 97892 0
Mr Jiaxu Wu
Address 97892 0
Australian Medical Industries
73 Bradman Street
Greystanes, NSW 2145
Country 97892 0
Phone 97892 0
+61 413 352 828
Fax 97892 0
Email 97892 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
Protected per data privacy law
What supporting documents are/will be available?
No other documents available
Summary results
No Results