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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/NCT03735810




Registration number
NCT03735810
Ethics application status
Date submitted
7/11/2018
Date registered
8/11/2018
Date last updated
7/01/2020

Titles & IDs
Public title
Safety and Tolerability Study of LBS-008 in Healthy Adult Subjects After Single and Multiple Doses
Scientific 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
Secondary ID [1] 0 0
LBS-008-CT01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LBS-008
Treatment: Drugs - Placebos

Experimental: SAD - Cohort 1 - 50 mg LBS-008 or placebo

Experimental: SAD - Cohort 2 - 100 mg LBS-008 or placebo

Experimental: SAD - Cohort 3 - 200 mg LBS-008 or placebo

Experimental: SAD - Cohort 4 - 400 mg LBS-008 or placebo

Experimental: SAD - Cohort 5 - 25 mg LBS-008 or placebo

Experimental: MAD - Cohort 1 - 10 mg LBS-008 or placebo

Experimental: MAD - Cohort 2 - 25 mg LBS-008 or placebo

Experimental: MAD - Cohort 3 - 5 mg LBS-008 or placebo

Experimental: MAD - Cohort 4 - 12 mg LBS-008 or placebo


Treatment: Drugs: LBS-008
LBS-008 oral capsules

Treatment: Drugs: Placebos
Oral capsules
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Area under the plasma concentration versus time curve from time 0 to the last timepoint with quantifiable concentration (AUC0-t)
Timepoint [1] 0 0
SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28
Primary outcome [2] 0 0
Area under the plasma concentration versus time curve from time 0 extrapolated to infinity (AUC0-inf)
Timepoint [2] 0 0
SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28
Primary outcome [3] 0 0
Maximum observed plasma concentration (Cmax)
Timepoint [3] 0 0
SAD portion: Day 1 to Day 6; MAD portion: Day 1 to Day 28
Primary outcome [4] 0 0
Time to maximum observed plasma concentration (Tmax)
Timepoint [4] 0 0
SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28
Primary outcome [5] 0 0
Terminal elimination rate constant
Timepoint [5] 0 0
SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28
Primary outcome [6] 0 0
Terminal phase half-life (t1/2)
Timepoint [6] 0 0
SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28
Primary outcome [7] 0 0
Apparent total body clearance (CL/F)
Timepoint [7] 0 0
SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28
Primary outcome [8] 0 0
Apparent volume of distribution (Vz/F)
Timepoint [8] 0 0
SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28
Primary outcome [9] 0 0
Number of participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs leading to discontinuation.
Timepoint [9] 0 0
SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28

Eligibility
Key inclusion criteria
- 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- 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.

Study design
Purpose of the study
Basic Science
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 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
15/11/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
16/09/2019
Sample size
Target
Accrual to date
Final
71
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Linear Clinical Research - Perth
Recruitment postcode(s) [1] 0 0
6009 - Perth

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
RBP4 Pty Ltd
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Belite Bio, Inc
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03735810
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/NCT03735810