Safety and Tolerability Study of LBS-008 in Healthy Adult Subjects After Single and Multiple Doses

Healthy Volunteer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03735810
• Other study ID #: LBS-008-CT01
• Status: Completed
• Phase: Phase 1
• Start date: November 15, 2018
• Est. completion date: September 16, 2019

Study information

• Verified date: August 2019
• Source: RBP4 Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: September 16, 2019
• Est. primary completion date: September 16, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• LBS-008
LBS-008 oral capsules
• Placebos
Oral capsules

Locations

Country	Name	City	State
Australia	Linear Clinical Research	Perth

Sponsors (2)

Lead Sponsor	Collaborator
RBP4 Pty Ltd	Belite Bio, Inc

Country where clinical trial is conducted

Australia, 

Outcome

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