Clinical trial NCT03735810: Safety and Tolerability Study of LBS-008 in Healthy Adult Subjects After Single and Multiple Doses
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: RBP4 Pty Ltd
Sponsor class: INDUSTRY
Collaborators: name: Belite Bio, Inc
First posted: 2018-11-08
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

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.

Primary outcomes:
measure: Area under the plasma concentration versus time curve from time 0 to the last timepoint with quantifiable concentration (AUC0-t)
timeFrame: SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28
measure: Area under the plasma concentration versus time curve from time 0 extrapolated to infinity (AUC0-inf)
timeFrame: SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28
measure: Maximum observed plasma concentration (Cmax)
timeFrame: SAD portion: Day 1 to Day 6; MAD portion: Day 1 to Day 28
measure: Time to maximum observed plasma concentration (Tmax)
timeFrame: SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28
measure: Terminal elimination rate constant
timeFrame: SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28
measure: Terminal phase half-life (t1/2)
timeFrame: SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28
measure: Apparent total body clearance (CL/F)
timeFrame: SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28
measure: Apparent volume of distribution (Vz/F)
timeFrame: SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28
measure: Number of participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs leading to discontinuation.
timeFrame: SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Perth
country: Australia
facility: Linear Clinical Research
Study officials:
References: