Rheumatoid ArthritisPhase 1NCT05053165
A Study to Assess the Safety and Tolerability of LB-P6 and LB-P8 in Healthy Participants
A Phase 1 study testing LB-P6 and LB-P8 in people with Rheumatoid Arthritis and Non-Alcoholic Steatohepatitis, run by LISCure Biosciences at 1 site in Australia.
Trial summary
The study is designed to assess the safety and tolerability of multiple ascending doses of LB-P6 or LB-P8 in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis, Non-Alcoholic Steatohepatitis
- What is being tested?
- LB-P6 and LB-P8
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteAustralia
- Study dates
- 4 Jan 2022to 29 Jun 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, aged 18 to 65 years (inclusive at the time of consent).
- BMI ≥ 18 to ≤ 32 kg/m2 and with weight ≥ 50 kg at Screening.
- 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.
- Female participants should meet 1 of the following criteria before they can participate in the study:
- Not of childbearing potential, defined as surgically sterile for at least 12 months prior to screening or postmenopausal
- 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.
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- 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.
- 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.
- 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.
Who cannot join
- Female participants who are pregnant, lactating, or who plan to become pregnant within 90 days of the EOS Visit.
- 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.
- 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.
- 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.
- The participant has taken any IPs within 30 days prior to the first dose of IP or 5 half-lives, whichever is longer.
- Positive test result for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus antibody (anti-HCV), FOB at Screening.
- 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).
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
The study is designed to assess the safety and tolerability of multiple ascending doses of LB-P6 or LB-P8 in healthy participants.
Read the 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.
- Being tested
- LB-P6, LB-P8, Placebo
- Medical subject headings
- Arthritis, Rheumatoid, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LB-P6Drug
Healthy subjects will be randomized to receive LB-P6 once daily orally
LB-P8Drug
Healthy subjects will be randomized to receive LB-P8 once daily orally
PlaceboDrug
Healthy subjects will be randomized to receive placebo once daily orally
| Study group | Role | What they receive |
|---|---|---|
| A (LB-P6) | Experimental | Healthy volunteers will be administered once daily orally Receives: Drug: LB-P6 |
| B (LB-P8) | Experimental | Healthy volunteers will be administered once daily orally Receives: Drug: LB-P8 |
| C (Placebo) | Experimental | Healthy volunteers will be administered once daily orally Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Measurements at Baseline till 14 days after the last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start4 Jan 2022
- Primary completion1 Apr 2022
- Study completion29 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- LISCure Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05053165
- Sponsor's protocol ID
- LB-001
- Status last verified
- Sep 2022
- First submitted
- 16 Sep 2021
- Last updated
- 6 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05053165
- Acronym / sponsor ID
- LB-001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- LISCure BiosciencesIndustry (pharma, biotech, devices)
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 29 Jun 2022 (actual)
- First posted
- 22 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is designed to assess the safety and tolerability of multiple ascending doses of LB-P6 or LB-P8 in healthy participants.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A (LB-P6) | Experimental | Drug: LB-P6Healthy volunteers will be administered once daily orally |
| B (LB-P8) | Experimental | Drug: LB-P8Healthy volunteers will be administered once daily orally |
| C (Placebo) | Experimental | Drug: PlaceboHealthy volunteers will be administered once daily orally |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female, aged 18 to 65 years (inclusive at the time of consent).
- BMI ≥ 18 to ≤ 32 kg/m2 and with weight ≥ 50 kg at Screening.
- 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.
- Female participants should meet 1 of the following criteria before they can participate in the study:
- 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.
Key exclusion criteria (8 listed)
- Female participants who are pregnant, lactating, or who plan to become pregnant within 90 days of the EOS Visit.
- 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.
- 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.
- 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.
- The participant has taken any IPs within 30 days prior to the first dose of IP or 5 half-lives, whichever is longer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LB-P6Healthy subjects will be randomized to receive LB-P6 once daily orally | Drug | A (LB-P6) |
| LB-P8Healthy subjects will be randomized to receive LB-P8 once daily orally | Drug | B (LB-P8) |
| PlaceboHealthy subjects will be randomized to receive placebo once daily orally | Drug | C (Placebo) |
Primary outcome
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
Time frame: Measurements at Baseline till 14 days after the last dose of study drug
Number of participants with treatment related adverse events as assessed by NCI-CTCAE v5.0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LB-P6 and LB-P8 in people with Rheumatoid Arthritis and Non-Alcoholic Steatohepatitis, run by LISCure Biosciences at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Measurements at Baseline till 14 days after the last dose of study drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2022; AzTrials last refreshed its copy on 7 Nov 2026.