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A Phase I Study to Evaluate LSALT Peptide

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03772678
Recruitment Status : Completed
First Posted : December 11, 2018
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
Arch Biopartners Inc.

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

Condition or disease Intervention/treatment Phase
None - Study is to Determine Safety in Healthy Participants Drug: LSALT peptide Other: 0.9% Saline Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Pharmacist not blind
Primary Purpose: Basic Science
Official 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
Actual Study Start Date : June 27, 2019
Actual Primary Completion Date : March 31, 2020
Actual Study Completion Date : March 31, 2020

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




Primary Outcome Measures :
  1. Low Dose SAD - Adverse events [ Time Frame: Within 4 days ]
    NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0

  2. SAD - Adverse Events [ Time Frame: Within 7 days ]
    NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0

  3. MAD - Adverse Events [ Time Frame: Within 21 days ]
    NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03772678


Locations
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Australia, Victoria
Nucleus Network Ltd.
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Arch Biopartners Inc.
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Responsible Party: Arch Biopartners Inc.
ClinicalTrials.gov Identifier: NCT03772678    
Other Study ID Numbers: AB001
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No