CompletedPhase 1ACTRN12619001609145

A Phase 1 study to evaluate Safety, Tolerability and Pharmacokinetics of LMR-123 in Healthy Subjects

A Phase 1, Randomized, Placebo-controlled Safety, Tolerability and Pharmacokinetic Study of Single Ascending Doses of LMR-123 in Healthy Subjects

Sponsor

Australia Medical Industries Pty Ltd.

Enrollment

52 participants

Start Date

Jan 21, 2020

Study Type

Interventional

Conditions

Acute Ischemic Stroke

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.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 49 Yearss

Inclusion Criteria10

Male or female healthy subjects, aged 18 to 49 years inclusive;
Body mass index of >19.0 kg/m2 to <29.0 kg/m2 at screening;
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;
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 ;
Females of childbearing potential must have a negative pregnancy test at screening (serum) and Day 1 (urine)
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.
Be of East Asian/South East Asian descent: Both parents must be from China, Hong Kong, Japan, Macau, Mongolia, North Korea, South Korea, Taiwan, Indochinese Peninsula comprising of Cambodia, Laos, Myanmar, Peninsula Malaysai, Thailand, Vietnam, Malay Archipelago/Nusantara comprising of the Andaman and Nicobar
Islands (India), Brunei, East Malaysia, East Timor, Indonesia (except Western New Guinea), Phillipines and Singapore.

Exclusion Criteria17

History or evidence of a clinically significant disorder.
History significant ophthalmic diseases including but not limited to vitreous opacities, glaucoma, cataract, ophthalmic infection and ophthalmic tumor;
History or presence of conditions known to interfere with the distribution, metabolism, or excretion of drugs;
Unwillingness to abstain from alcohol from 48 hours prior to investigational product administration.
A positive urine drug screen or alcohol breath test at screening;
Subjects smokes more than 10 cigarettes per day within 3 months of screening
History of surgery or major trauma within 12 weeks of screening, or surgery planned during the study;
History of significant neurological diseases, including stroke, transient ischemic attacks, seizures, and vascular malformations;
Positive screen for human immunodeficiency virus, hepatitis B virus surface antigen or hepatitis C virus antibody;
Treatment with any investigational product within 30 days or 5 half-lives
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;
History of cancer,
History of allergic reactions
Subject has a positive test for tuberculosis (TB) during screening or a known history of active or latent TB
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.
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;
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.

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Interventions

Subjects will be administered LMR-123 or matching placebo in cohort 1-7 via intravenous infusion over 30 minutes on day 1 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); • Cohort 7 (Subjects of East Asian & South East Asian descent only) -12mg/Kg LMR-123 (n=6), placebo (n=2) (blinded)