A Phase I Study to Evaluate LSALT Peptide

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

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

Study Overview

• Status: Completed
• Conditions: None - Study is to Determine Safety in Healthy Participants
• Intervention / Treatment: Other: 0.9% Saline; Drug: LSALT peptide

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Nucleus Network Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 0.9% Saline For SAD and MAD arms.	Other: 0.9% Saline; saline
Experimental: Single Ascending Dose - Low Dose; 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; novel 16 amino acid peptide
Experimental: Single Ascending Dose; 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; novel 16 amino acid peptide
Experimental: Multiple Ascending Dose; 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; novel 16 amino acid peptide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Evaluation	To determine the safety and tolerability of 3 single and multiple ascending doses of LSALT peptide (1.0mg, 2.5mg, 5.0mg) in healthy participants.	Within 21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic Evaluation	To evaluate the PK and pharmacodynamics (PD) of LSALT peptide in healthy participants.	Within 21 days

Collaborators and Investigators

• Sponsor: Arch Biopartners Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2019
• Primary Completion (Actual): March 31, 2020
• Study Completion (Actual): March 31, 2020

Study Registration Dates

• First Submitted: December 9, 2018
• First Submitted That Met QC Criteria: December 9, 2018
• First Posted (Actual): December 11, 2018

Study Record Updates

• Last Update Posted (Actual): November 29, 2024
• Last Update Submitted That Met QC Criteria: November 22, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: AB001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No