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

NCT ID: NCT03735810

Last Updated: 2020-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-15
• Study Completion Date: 2019-09-16

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.

Conditions

Healthy Volunteer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

SAD - Cohort 1

50 mg LBS-008 or placebo

Group Type: EXPERIMENTAL

LBS-008

Intervention Type: DRUG

LBS-008 oral capsules

Placebos

Intervention Type: DRUG

Oral capsules

SAD - Cohort 2

100 mg LBS-008 or placebo

Group Type: EXPERIMENTAL

LBS-008

Intervention Type: DRUG

LBS-008 oral capsules

Placebos

Intervention Type: DRUG

Oral capsules

SAD - Cohort 3

200 mg LBS-008 or placebo

Group Type: EXPERIMENTAL

LBS-008

Intervention Type: DRUG

LBS-008 oral capsules

Placebos

Intervention Type: DRUG

Oral capsules

SAD - Cohort 4

400 mg LBS-008 or placebo

Group Type: EXPERIMENTAL

LBS-008

Intervention Type: DRUG

LBS-008 oral capsules

Placebos

Intervention Type: DRUG

Oral capsules

SAD - Cohort 5

25 mg LBS-008 or placebo

Group Type: EXPERIMENTAL

LBS-008

Intervention Type: DRUG

LBS-008 oral capsules

Placebos

Intervention Type: DRUG

Oral capsules

MAD - Cohort 1

10 mg LBS-008 or placebo

Group Type: EXPERIMENTAL

LBS-008

Intervention Type: DRUG

LBS-008 oral capsules

Placebos

Intervention Type: DRUG

Oral capsules

MAD - Cohort 2

25 mg LBS-008 or placebo

Group Type: EXPERIMENTAL

LBS-008

Intervention Type: DRUG

LBS-008 oral capsules

Placebos

Intervention Type: DRUG

Oral capsules

MAD - Cohort 3

5 mg LBS-008 or placebo

Group Type: EXPERIMENTAL

LBS-008

Intervention Type: DRUG

LBS-008 oral capsules

Placebos

Intervention Type: DRUG

Oral capsules

MAD - Cohort 4

12 mg LBS-008 or placebo

Group Type: EXPERIMENTAL

LBS-008

Intervention Type: DRUG

LBS-008 oral capsules

Placebos

Intervention Type: DRUG

Oral capsules

Interventions

LBS-008

LBS-008 oral capsules

Intervention Type: DRUG

Placebos

Oral capsules

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Belite Bio, Inc

INDUSTRY

Sponsor Role: collaborator

RBP4 Pty Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Linear Clinical Research

Perth, , Australia

Countries

Australia

Other Identifiers

LBS-008-CT01

Identifier Type: -

Identifier Source: org_study_id