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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05053165




Registration number
NCT05053165
Ethics application status
Date submitted
16/09/2021
Date registered
22/09/2021
Date last updated
6/09/2022

Titles & IDs
Public title
A Study to Assess the Safety and Tolerability of LB-P6 and LB-P8 in Healthy Participants
Scientific title
A Phase 1, Randomised, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of LB-P6 or LB-P8 in Healthy Participants
Secondary ID [1] 0 0
LB-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Non-Alcoholic Steatohepatitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Diet and Nutrition 0 0 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LB-P6
Treatment: Drugs - LB-P8
Treatment: Drugs - Placebo

Experimental: A (LB-P6) - Healthy volunteers will be administered once daily orally

Experimental: B (LB-P8) - Healthy volunteers will be administered once daily orally

Experimental: C (Placebo) - Healthy volunteers will be administered once daily orally


Treatment: Drugs: LB-P6
Healthy subjects will be randomized to receive LB-P6 once daily orally

Treatment: Drugs: LB-P8
Healthy subjects will be randomized to receive LB-P8 once daily orally

Treatment: Drugs: Placebo
Healthy subjects will be randomized to receive placebo once daily orally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To assess the safety and tolerability of multiple ascending doses of LB-P6 or LB-P8 in healthy participants through adverse events as assessed by NCI-CTCAE v5.0
Timepoint [1] 0 0
Measurements at Baseline till 14 days after the last dose of study drug

Eligibility
Key inclusion criteria
1. Male or female, aged 18 to 65 years (inclusive at the time of consent).

2. BMI = 18 to = 32 kg/m2 and with weight = 50 kg at Screening.

3. Must have a negative urine drug screen at the Screening Visit and the day before
dosing (Day -1); one repeat urine drug may be conducted for a suspected false positive
result.

4. Female participants should meet 1 of the following criteria before they can
participate in the study:

1. Not of childbearing potential, defined as surgically sterile for at least 12
months prior to screening or postmenopausal

2. Of childbearing potential and agrees to take effective contraceptive measures
throughout the study period from study entry (ie, screening) until at least 3
months after the last dose of IP.

3. Of childbearing potential and in an exclusive relationship with a partner who has
had a bilateral vasectomy at least 6 months prior to study entry.

Female participant of childbearing potential must have a negative serum pregnancy test
at Screening, and a negative urine pregnancy test at Baseline (ie, Day -1), and be
willing to have additional pregnancy tests, as required, throughout the study, at the
discretion of the PI or designee.

5. Male participant: has undergone bilateral vasectomy (at least 6 months prior to study
entry) or agrees to use effective contraceptive measures and not donate sperm
throughout the study period from study entry (ie, Screening) until at least 3 months
after the last dose of IP.

6. Must agree to adhere to the current state and national advice regarding minimising
exposure to COVID-19 from the first Screening Visit until the EOS Visit.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Female participants who are pregnant, lactating, or who plan to become pregnant within
90 days of the EOS Visit.

2. The participant has either a history or presence of any clinically significant
immunological disorder/disease (such as autoimmune diseases, etc.), cardiovascular,
thromboembolic events, respiratory, metabolic, renal, hepatic, gastrointestinal,
endocrinological (particularly diabetes or prediabetes), haematological,
dermatological, venereal, neurological, chronic infectious or psychiatric disease or
other major disorder that, in the opinion of the PI or designee, may interfere with
trial compliance, completion, or accurate assessment of trial outcomes or safety.

3. The participant has taken prescription (including antibiotics and anti-virals) or non
prescription medication, herbal remedies, vitamins or minerals, any probiotics and
yeast supplements within 14 days prior to the first dose of IP unless in the opinion
of the PI or designee the medication will not compromise participant safety or
interfere with study procedures or data validity. Participants may be rescreened after
a washout period of 14 days. Use of contraceptives and paracetamol up to 2 g/day
and/or nonsteroidal anti inflammatory drugs (NSAIDs) for symptomatic relief of minor
symptoms are allowed.

4. The participant has a substance abuse-related disorder or has a history of drug,
alcohol, and/or substance abuse deemed significant by the PI or designee. Any
participant with a positive screen for drugs of abuse or alcohol at Screening or on
Day -1 will also be excluded.

5. The participant has taken any IPs within 30 days prior to the first dose of IP or 5
half-lives, whichever is longer.

6. Positive test result for human immunodeficiency virus (HIV), hepatitis B surface
antigen (HbsAg), or hepatitis C virus antibody (anti-HCV), FOB at Screening.

7. The participant has a fever (body temperature > 38°C) or symptomatic viral or
bacterial infection within 2 weeks prior to admission to the clinical research unit
(CRU).

8. The participant has undergone vaccination (including with a live-attenuated vaccine)
within 30 days prior to Baseline (Day -1) through to the end of the study.

Study design
Purpose of the study
Treatment
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
Other
Other design features
Phase
Phase 1
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
4/01/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/06/2022
Sample size
Target
Accrual to date
Final
31
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Cmax Clinical Research - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
LISCure Biosciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The study is designed to assess the safety and tolerability of multiple ascending doses of
LB-P6 or LB-P8 in healthy participants.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05053165
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05053165