A Study to Assess the Safety and Tolerability of LB-P6 and LB-P8 in Healthy Participants

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

The study is designed to assess the safety and tolerability of multiple ascending doses of LB-P6 or LB-P8 in healthy participants.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis; Non-Alcoholic Steatohepatitis
• Intervention / Treatment: Drug: LB-P6; Drug: LB-P8; Drug: Placebo

Detailed Description

This is randomised, double-blind, placebo-controlled, single centre study to assess the safety and tolerability of multiple ascending doses of LB-P6 or LB-P8 in healthy participants.

A total of up to 30 healthy participants will be enrolled in 2 cohorts.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • Adelaide, Australia, 5000
    • CMAX Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A (LB-P6); Healthy volunteers will be administered once daily orally	Drug: LB-P6; Healthy subjects will be randomized to receive LB-P6 once daily orally
Experimental: B (LB-P8); Healthy volunteers will be administered once daily orally	Drug: LB-P8; Healthy subjects will be randomized to receive LB-P8 once daily orally
Experimental: C (Placebo); Healthy volunteers will be administered once daily orally	Drug: Placebo; Healthy subjects will be randomized to receive placebo once daily orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Number of participants with treatment related adverse events as assessed by NCI-CTCAE v5.0	Measurements at Baseline till 14 days after the last dose of study drug

Collaborators and Investigators

• Sponsor: LISCure Biosciences

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2022
• Primary Completion (Actual): April 1, 2022
• Study Completion (Actual): June 29, 2022

Study Registration Dates

• First Submitted: September 16, 2021
• First Submitted That Met QC Criteria: September 21, 2021
• First Posted (Actual): September 22, 2021

Study Record Updates

• Last Update Posted (Actual): September 6, 2022
• Last Update Submitted That Met QC Criteria: September 1, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: LB-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No