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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.

Tracking Information
First Submitted Date  ICMJE December 9, 2018
First Posted Date  ICMJE December 11, 2018
Last Update Posted Date June 18, 2020
Actual Study Start Date  ICMJE June 27, 2019
Actual Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2018)
  • Low Dose SAD - Adverse events [ Time Frame: Within 4 days ]
    NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0
  • SAD - Adverse Events [ Time Frame: Within 7 days ]
    NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0
  • MAD - Adverse Events [ Time Frame: Within 21 days ]
    NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Original Primary Outcome Measures  ICMJE
 (submitted: December 9, 2018)
Adverse events [ Time Frame: Within 7 days ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase I Study to Evaluate LSALT Peptide
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Pharmacist not blind
Primary Purpose: Basic Science
Condition  ICMJE None - Study is to Determine Safety in Healthy Participants
Intervention  ICMJE
  • Drug: LSALT peptide
    novel 16 amino acid peptide
  • Other: 0.9% Saline
    saline
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    0.9% Saline For SAD and MAD arms.
    Intervention: Other: 0.9% 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.
    Intervention: Drug: LSALT 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.
    Intervention: Drug: LSALT 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.
    Intervention: Drug: LSALT peptide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 16, 2020)
52
Original Estimated Enrollment  ICMJE
 (submitted: December 9, 2018)
40
Actual Study Completion Date  ICMJE March 31, 2020
Actual Primary Completion Date March 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03772678
Other Study ID Numbers  ICMJE AB001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Arch Biopartners Inc.
Study Sponsor  ICMJE Arch Biopartners Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Arch Biopartners Inc.
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP