Healthy VolunteerPhase 1NCT03735810
Safety and Tolerability Study of LBS-008 in Healthy Adult Subjects After Single and Multiple Doses
A Phase 1 study testing LBS-008 in people with Healthy Volunteer, run by RBP4 Pty Ltd at 1 site in Australia.
Trial summary
This is a single center, randomized, double-blind, placebo-controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) study is planned to assess safety, pharmacokinetics (PK), and pharmacodynamics of LBS-008 in healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- LBS-008
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteAustralia
- Study dates
- 15 Nov 2018to 16 Sep 2019
- 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
- The subject is male or female, 18 to 65 years of age, inclusive, at screening.
- The subject voluntarily consents to participate in this study and provides written informed consent before the start of any study-specific procedures.
- The subject is willing and able to remain in the study unit for the entire duration of the confinement period and return for outpatient visits.
- Female subjects must be of nonchildbearing potential (defined as surgically sterile [i.e., had a bilateral tubal ligation, hysterectomy, or bilateral oophorectomy at least 6 months before the dose of study drug] or postmenopausal for at least 1 year before study drug administration confirmed by FSH test at screening; FSH level >40 mIU/mL). Female subjects may also be considered of non-childbearing if they have a confirmed medical condition which would deem the subject as infertile. E.g. MRKH Syndrome (Mullerian Agenesis) or another applicable condition.
- Male subjects must be surgically sterile (i.e., vasectomy) for at least 3 months before screening; or remain abstinent or agree to use a highly effective form of contraception when sexually active with a female partner for 90 days after study drug administration. Highly effective contraception requires use of a condom and appropriate contraceptive measures for your female partner (i.e. oral, injected or implanted hormonal methods, or placement of an intrauterine device or intrauterine system). This requirement does not apply to subjects in a same sex relationship and female partners of non-childbearing potential.
- The subject has a body mass index (BMI) of 18 to 30 kg/m2, inclusive, and weighs 50 to 100 kg (110 to 220 pounds), inclusive, at screening and check-in.
- The subject is considered to be in stable health by the investigator.
- The subject agrees to comply with all protocol requirements.
Who cannot join
- Any significant acute or chronic medical illness including history or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease
- Vitamin A deficiency.
- Any recent viral or bacterial infection.
- Participated in any clinical study in last 6 weeks.
- History of significant drug allergy
- History of significant vision, ocular or retinal disorder.
- Recent surgery, blood transfusion, drug or alcohol abuse and use of tobacco or nicotine containing products in past month.
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECGs, or clinical laboratory determinations Other protocol-defined inclusion/exclusion criteria could apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LBS-008 in Healthy Adult Subjects
This is a single center, randomized, double-blind, placebo-controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) study is planned to assess safety, pharmacokinetics (PK), and pharmacodynamics of LBS-008 in healthy adult volunteers.
- Conditions
- Healthy Volunteer
- Being tested
- LBS-008, Placebos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LBS-008Drug
LBS-008 oral capsules
PlacebosDrug
Oral capsules
| Study group | Role | What they receive |
|---|---|---|
| SAD - Cohort 1 | Experimental | 50 mg LBS-008 or placebo Receives: Drug: LBS-008; Drug: Placebos |
| SAD - Cohort 2 | Experimental | 100 mg LBS-008 or placebo Receives: Drug: LBS-008; Drug: Placebos |
| SAD - Cohort 3 | Experimental | 200 mg LBS-008 or placebo Receives: Drug: LBS-008; Drug: Placebos |
| SAD - Cohort 4 | Experimental | 400 mg LBS-008 or placebo Receives: Drug: LBS-008; Drug: Placebos |
| SAD - Cohort 5 | Experimental | 25 mg LBS-008 or placebo Receives: Drug: LBS-008; Drug: Placebos |
| MAD - Cohort 1 | Experimental | 10 mg LBS-008 or placebo Receives: Drug: LBS-008; Drug: Placebos |
| MAD - Cohort 2 | Experimental | 25 mg LBS-008 or placebo Receives: Drug: LBS-008; Drug: Placebos |
| MAD - Cohort 3 | Experimental | 5 mg LBS-008 or placebo Receives: Drug: LBS-008; Drug: Placebos |
| MAD - Cohort 4 | Experimental | 12 mg LBS-008 or placebo Receives: Drug: LBS-008; Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve from time 0 to the last timepoint with quantifiable concentration (AUC0-t)
Measured: SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28
Area under the plasma concentration versus time curve from time 0 extrapolated to infinity (AUC0-inf)
Measured: SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28
Maximum observed plasma concentration (Cmax)
Measured: SAD portion: Day 1 to Day 6; MAD portion: Day 1 to Day 28
Time to maximum observed plasma concentration (Tmax)
Measured: SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28
Terminal elimination rate constant
Measured: SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28
Terminal phase half-life (t1/2)
Measured: SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28
Apparent total body clearance (CL/F)
Measured: SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28
Apparent volume of distribution (Vz/F)
Measured: SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28
Number of participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs leading to discontinuation.
Measured: SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start15 Nov 2018
- Primary completion16 Sep 2019
- Study completion16 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- RBP4 Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Belite Bio, Inc
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03735810
- Sponsor's protocol ID
- LBS-008-CT01
- Status last verified
- Aug 2019
- First submitted
- 7 Nov 2018
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: After completion of the study, data may be considered for reporting at a scientific meeting or for publication in a scientific journal. In these cases, the sponsor will be responsible for these activities and will work with the investigators to determine how the manuscript is written and edited, the number and order of authors, the publication to which it will be submitted, and any other related issues. The sponsor has final approval authority of all such issues. Data are the property of the sponsor and cannot be published without their prior authorization, but data and any publication thereof will not be unduly withheld.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LBS-008 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT03735810
- Acronym / sponsor ID
- LBS-008-CT01
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- RBP4 Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- Belite Bio, Inc
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 16 Sep 2019 (actual)
- Study completion
- 16 Sep 2019 (actual)
- First posted
- 8 Nov 2018 (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.
This is a single center, randomized, double-blind, placebo-controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) study is planned to assess safety, pharmacokinetics (PK), and pharmacodynamics of LBS-008 in healthy adult volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| SAD - Cohort 1 | Experimental | Drug: LBS-008, Drug: Placebos50 mg LBS-008 or placebo |
| SAD - Cohort 2 | Experimental | Drug: LBS-008, Drug: Placebos100 mg LBS-008 or placebo |
| SAD - Cohort 3 | Experimental | Drug: LBS-008, Drug: Placebos200 mg LBS-008 or placebo |
| SAD - Cohort 4 | Experimental | Drug: LBS-008, Drug: Placebos400 mg LBS-008 or placebo |
| SAD - Cohort 5 | Experimental | Drug: LBS-008, Drug: Placebos25 mg LBS-008 or placebo |
| MAD - Cohort 1 | Experimental | Drug: LBS-008, Drug: Placebos10 mg LBS-008 or placebo |
| MAD - Cohort 2 | Experimental | Drug: LBS-008, Drug: Placebos25 mg LBS-008 or placebo |
| MAD - Cohort 3 | Experimental | Drug: LBS-008, Drug: Placebos5 mg LBS-008 or placebo |
| MAD - Cohort 4 | Experimental | Drug: LBS-008, Drug: Placebos12 mg LBS-008 or placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- The subject is male or female, 18 to 65 years of age, inclusive, at screening.
- The subject voluntarily consents to participate in this study and provides written informed consent before the start of any study-specific procedures.
- The subject is willing and able to remain in the study unit for the entire duration of the confinement period and return for outpatient visits.
- Female subjects must be of nonchildbearing potential (defined as surgically sterile [i.e., had a bilateral tubal ligation, hysterectomy, or bilateral oophorectomy at least 6 months before the dose of study drug] or postmenopausal for at least 1 year before study drug administration confirmed by FSH test at screening; FSH level >40 mIU/mL). Female subjects may also be considered of non-childbearing if they have a confirmed medical condition which would deem the subject as infertile. E.g. MRKH Syndrome (Mullerian Agenesis) or another applicable condition.
- Male subjects must be surgically sterile (i.e., vasectomy) for at least 3 months before screening; or remain abstinent or agree to use a highly effective form of contraception when sexually active with a female partner for 90 days after study drug administration. Highly effective contraception requires use of a condom and appropriate contraceptive measures for your female partner (i.e. oral, injected or implanted hormonal methods, or placement of an intrauterine device or intrauterine system). This requirement does not apply to subjects in a same sex relationship and female partners of non-childbearing potential.
Key exclusion criteria (8 listed)
- Any significant acute or chronic medical illness including history or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease
- Vitamin A deficiency.
- Any recent viral or bacterial infection.
- Participated in any clinical study in last 6 weeks.
- History of significant drug allergy
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 |
|---|---|---|
| LBS-008LBS-008 oral capsules | Drug | MAD - Cohort 1, MAD - Cohort 2, MAD - Cohort 3, MAD - Cohort 4, SAD - Cohort 1, SAD - Cohort 2, SAD - Cohort 3, SAD - Cohort 4, SAD - Cohort 5 |
| PlacebosOral capsules | Drug | MAD - Cohort 1, MAD - Cohort 2, MAD - Cohort 3, MAD - Cohort 4, SAD - Cohort 1, SAD - Cohort 2, SAD - Cohort 3, SAD - Cohort 4, SAD - Cohort 5 |
Primary outcome
Area under the plasma concentration versus time curve from time 0 to the last timepoint with quantifiable concentration (AUC0-t)
Time frame: SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28
Area under the plasma concentration versus time curve from time 0 extrapolated to infinity (AUC0-inf)
Time frame: SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28
Maximum observed plasma concentration (Cmax)
Time frame: SAD portion: Day 1 to Day 6; MAD portion: Day 1 to Day 28
Time to maximum observed plasma concentration (Tmax)
Time frame: SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28
Terminal elimination rate constant
Time frame: SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28
Terminal phase half-life (t1/2)
Time frame: SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28
Apparent total body clearance (CL/F)
Time frame: SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28
Apparent volume of distribution (Vz/F)
Time frame: SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28
Number of participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs leading to discontinuation.
Time frame: SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28
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 7 Jan 2020.
- Individual participant dataSharing planned: No. After completion of the study, data may be considered for reporting at a scientific meeting or for publication in a scientific journal. In these cases, the sponsor will be responsible for these activities and will work with the investigators to determine how the manuscript is written and edited, the number and order of authors, the publication to which it will be submitted, and any other related issues. The sponsor has final approval authority of all such issues. Data are the property of the sponsor and cannot be published without their prior authorization, but data and any publication thereof will not be unduly withheld.
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Screening Protocol
Pain
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 LBS-008 in people with Healthy Volunteer, run by RBP4 Pty Ltd 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 8 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 7 Jan 2020. 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?
Area under the plasma concentration versus time curve from time 0 to the last timepoint with quantifiable concentration (AUC0-t) (time frame: SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28). The study lists 9 primary outcomes in all. 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 7 Jan 2020.