A Phase I Study to Evaluate LSALT Peptide

Study Overview
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Brief Summary
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A phase I double-blind, placebo-controlled, randomized, single and multiple ascending dose finding study to evaluate the safety and pharmacokinetic profile of LSALT peptide in healthy participants

Official Title
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A Phase I Double-blind, Placebo-controlled, Randomized, Single and Multiple Ascending Dose Finding Study to Evaluate the Safety and Pharmacokinetic Profile of LSALT Peptide in Healthy Participants

Conditions
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None - Study is to Determine Safety in Healthy Participants

Intervention / Treatment
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* Drug: LSALT peptide
* Other: 0.9% Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: No prior history of major organ or systemic disease including diabetes, hypertension, kidney, heart or liver disease. Participants with childhood asthma are acceptable. Normal hematology, clinical chemistry and urinalysis parameters at screening, unless not deemed clinically significant by the investigator. Body Mass Index (BMI) between 18 kg/m2 and 32 kg/m2 (inclusive) Taking no prescription medications 2 weeks prior to admission or over-the-counter medications 7 days prior to admission. Occasional use of paracetamol or ibuprofen (up to 1000 mg and 400 mg/day respectively) are acceptable. Routine vitamins and supplements are permissible at the discretion of the investigator. Able to allow intravenous medication to be administered. Males (along with their female partners) and females of childbearing potential (defined as a female who is not menopausal or surgically sterilized) must be willing to use an acceptable method of birth control during heterosexual activities including a condom and a second highly effective method (i.e., hormonal contraceptive, intra-uterine device) or abstinence for the duration of the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Males should continue with the aforementioned contraception for 90 days after the last dose and females should continue with the aforementioned contraception for 60 days after last dose. Able to understand and willing to sign an ethics committee-approved written informed consent document Non-smokers. Social and light smokers of up to 10 cigarettes per day who can abstain from smoking during the confinement period and have no evidence of underlying lung disease (bronchitis, COPD or reactive airways disease). Willing to remain abstinent from alcohol 24 hours prior to admission and until after the confinement period in the unit. Exclusion Criteria: A history of cardiovascular disease, diabetes or hypertension (>150/90 after 5 minutes sitting), significant neurological, pulmonary (including asthma), hepatic, rheumatic, autoimmune, haematological, metabolic or renal disorder. Prescription medications are prohibited. No prescription medications 2 weeks prior to admission or over-the-counter medications 7 days prior to admission. Occasional use of paracetamol or ibuprofen (up to 1000 mg and 400 mg/day respectively) are acceptable. Routine vitamins and supplements are permissible at the discretion of the investigator. Any moderate or severe allergies, including anaphylaxis, to food, drugs or environmental allergens. Mild allergies such as hayfever may be included. Females who are pregnant or lactating. Women of childbearing potential must have a negative pregnancy test within 14 days of study initiation and at baseline. Consumption of caffeine 48 hours prior to start of study treatment and whilst confined to the unit. History of any psychiatric illness or psychological disorder which may impair the ability to provide written informed consent or participate in the study Clinically significant abnormal laboratory value at screening as determined by the Investigator. Participant is sero-positive to HIV-1 or HIV-2, HCV or HBV. History or presence of alcoholism within two years prior to the first study drug administration or drugs of abuse unless it can be explained to the satisfaction of the investigator that it is due to a standard dose of a prescribed medication and that an adequate wash-out will occur prior to admission. No findings on clinical examination that, in the opinion of the investigator, could compromise the safety of the participant or the results of the study. Blood donation or significant blood loss within 60 days prior to the first study drug administration. Administration of investigational product in another trial within 30 days prior to the first study drug administration or five half-lives, whichever is longer. Surgery within the past 3 months prior to the first study drug administration determined by the PI to be clinically relevant. Active malignancy or history of malignancy in the past 5 years.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>0.9% Saline For SAD and MAD arms. | Other: 0.9% Saline<br>* saline<br>|
| Experimental: Single Ascending Dose - Low Dose<br>LSALT peptide (1mg/mL in 0.9% saline) Single escalating dose - 0.01mg, 0.1mg, 0.3mg, 0.5mg intravenously Escalation to 2.5mg and 5mg doses in next cohorts if no adverse effects are seen after 10-14 days. | Drug: LSALT peptide<br>* novel 16 amino acid peptide<br>|
| Experimental: Single Ascending Dose<br>LSALT peptide (1mg/mL in 0.9% saline) Single dose - 1mg intravenously over 2h Escalation to next dose in next participant every 72h if no adverse effects are seen. | Drug: LSALT peptide<br>* novel 16 amino acid peptide<br>|
| Experimental: Multiple Ascending Dose<br>LSALT peptide (1mg/mL in 0.9% saline) Dose will be determined based on results of SAD arm. LSALT will be administered intravenously once or twice daily for 3 days. | Drug: LSALT peptide<br>* novel 16 amino acid peptide<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low Dose SAD - Adverse events | NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | Within 4 days | 
| SAD - Adverse Events | NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | Within 7 days | 
| MAD - Adverse Events | NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0 | Within 21 days |