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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03772678
Ethics application status
Date submitted
9/12/2018
Date registered
11/12/2018
Date last updated
18/06/2020

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 - NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Timepoint [1] 0 0
Within 4 days
Primary outcome [2] 0 0
SAD - Adverse Events - NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Timepoint [2] 0 0
Within 7 days
Primary outcome [3] 0 0
MAD - Adverse Events - NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0
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
Gender
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
Basic Science
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
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
Trial website
https://clinicaltrials.gov/show/NCT03772678
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

Summary results
Other publications