A Phase I Study to Evaluate LSALT Peptide | NCT03772678

NCT03772678

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	0.9% Saline For SAD and MAD arms.	Other: 0.9% Saline
Single Ascending Dose - Low Dose	Experimental	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
Single Ascending Dose	Experimental	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
Multiple Ascending Dose	Experimental	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

Name	Type	Description	Arm Group Labels	Other Names
LSALT peptide	Drug	novel 16 amino acid peptide	Multiple Ascending Dose Single Ascending Dose Single Ascending Dose - Low Dose

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

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

Eligibility Module

Eligibility Criteria

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.

Facility	Status	City	State	ZIP	Country	Contacts
Nucleus Network Ltd.		Melbourne	Victoria	3004	Australia

Arm/Group Information

ID	Title	Description
FG000	LSALT Peptide - 0.01mg	LSALT peptide (1mg/mL in 0.9% saline) single dose intravenously. Escalation to 0.1mg dose in next cohort if no adverse effects are seen after 3 days. LSALT peptide: novel 16 amino acid peptide
FG001	LSALT Peptide - 0.1mg	LSALT peptide (1mg/mL in 0.9% saline) single dose intravenously. Escalation to 0.3mg dose in next cohort if no adverse effects are seen after 3 days. LSALT peptide: novel 16 amino acid peptide
FG002	LSALT Peptide - 0.3mg	LSALT peptide (1mg/mL in 0.9% saline) single dose intravenously. Escalation to 0.5mg dose in next cohort if no adverse effects are seen after 3 days. LSALT peptide: novel 16 amino acid peptide
FG003	LSALT Peptide - 0.5mg	LSALT peptide (1mg/mL in 0.9% saline) single dose intravenously. Escalation to 1.0mg dose in next cohort if no adverse effects are seen after 10-14 days. LSALT peptide: novel 16 amino acid peptide
FG004	LSALT Peptide - 1.0mg	LSALT peptide (1mg/mL in 0.9% saline) single dose - 1.0mg intravenously over 2h. Escalation to next dose (2.5mg) in next cohort if no adverse effects are seen. LSALT peptide: novel 16 amino acid peptide
FG005	LSALT Peptide - 2.5mg	LSALT peptide (1mg/mL in 0.9% saline) single dose - 2.5mg intravenously over 2h. Escalation to next dose (5.0mg) in next cohort if no adverse effects are seen. LSALT peptide: novel 16 amino acid peptide
FG006	LSALT Peptide - 5.0mg	LSALT peptide (1mg/mL in 0.9% saline) single dose - 5.0mg intravenously over 2h. Escalation to multiple ascending dose cohort if no adverse effects are seen. LSALT peptide: novel 16 amino acid peptide
FG007	Placebo - Single Dose	0.9% saline as placebo for single dose cohorts (1.0mg, 2.5mg, 5.0mg)
FG008	LSALT Peptide - 1.0mg, Multiple Ascending Dose	LSALT peptide (1mg/mL in 0.9% saline) single dose (1.0mg) per day intravenously over 2h. LSALT will be administered intravenously once daily for 3 days. LSALT peptide: novel 16 amino acid peptide
FG009	LSALT Peptide - 2.5mg, Multiple Ascending Dose	LSALT peptide (1mg/mL in 0.9% saline) single dose (2.5mg) per day intravenously over 2h. LSALT will be administered intravenously once daily for 3 days. LSALT peptide: novel 16 amino acid peptide
FG010	LSALT Peptide - 5.0mg, Multiple Ascending Dose	LSALT peptide (1mg/mL in 0.9% saline) single dose (5.0mg) per day intravenously over 2h. LSALT will be administered intravenously once daily for 3 days. LSALT peptide: novel 16 amino acid peptide
FG011	Placebo - Multiple Ascending Dose	0.9% saline as placebo for multiple ascending dose cohorts (1.0mg, 2.5mg, 5.0mg)

ID	Title	Description
BG000	LSALT Peptide - 0.01mg	LSALT peptide (1mg/mL in 0.9% saline) single dose intravenously. Escalation to 0.1mg dose in next cohort if no adverse effects are seen after 3 days. LSALT peptide: novel 16 amino acid peptide
BG001	LSALT Peptide - 0.1mg

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

The Safety Population was comprised of all randomised subjects who received any amount of study drug in the single ascending dose and multiple ascending dose cohorts and were based on the actual treatment received, if this differs from that to which the subject was randomised. The Safety Population was used for the summaries of all safety tolerability.

Posted

Number

participants

Within 21 days

ID	Title	Description
OG000	LSALT Peptide - 0.01mg	LSALT peptide (1mg/mL in 0.9% saline) single dose intravenously. Escalation to 0.1mg dose in next cohort if no adverse effects are seen after 3 days. LSALT peptide: novel 16 amino acid peptide

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	LSALT Peptide - 0.01mg	LSALT peptide (1mg/mL in 0.9% saline) single dose intravenously. Escalation to 0.1mg dose in next cohort if no adverse effects are seen after 3 days. LSALT peptide: novel 16 amino acid peptide

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
General Disorders and Administration Site Conditions	Injury, poisoning and procedural complications		Non-systematic Assessment

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jan 30, 2020	May 17, 2022	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Apr 2, 2020	May 17, 2022	SAP_001.pdf
ICF	No	No	Yes	Informed Consent Form	Jun 6, 2019	May 17, 2022	ICF_002.pdf

ID	Term
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations