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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03772678




Registration number
NCT03772678
Ethics application status
Date submitted
9/12/2018
Date registered
11/12/2018

Titles & IDs
Public title
A Phase I Study to Evaluate LSALT Peptide
Scientific title
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
Secondary ID [1] 0 0
AB001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
None - Study is to Determine Safety in Healthy Participants 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LSALT peptide
Other interventions - 0.9% Saline

Placebo comparator: Placebo - 0.9% Saline For SAD and MAD arms.

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.

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.

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.


Treatment: Drugs: LSALT peptide
novel 16 amino acid peptide

Other interventions: 0.9% Saline
saline
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Low Dose SAD - Adverse events
Timepoint [1] 0 0
Within 4 days
Primary outcome [2] 0 0
SAD - Adverse Events
Timepoint [2] 0 0
Within 7 days
Primary outcome [3] 0 0
MAD - Adverse Events
Timepoint [3] 0 0
Within 21 days

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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 design
Purpose of the study
Other
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
Parallel
Other design features
Phase
Phase 0
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
27/06/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/03/2020
Sample size
Target
Accrual to date
Final
52
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Ltd. - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Arch Biopartners Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03772678