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

• ClinicalTrials.gov Identifier: NCT03735810
• Recruitment Status: Completed
• First Posted: November 8, 2018
• Last Update Posted: January 7, 2020
• Sponsor: RBP4 Pty Ltd
• Collaborator: Belite Bio, Inc
• Information provided by (Responsible Party): RBP4 Pty Ltd

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Healthy Volunteer	Drug: LBS-008; Drug: Placebos	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 71 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• 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
• Actual Study Start Date: November 15, 2018
• Actual Primary Completion Date: September 16, 2019
• Actual Study Completion Date: September 16, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: SAD - Cohort 1; 50 mg LBS-008 or placebo	Drug: LBS-008; LBS-008 oral capsules; Drug: Placebos; Oral capsules
Experimental: SAD - Cohort 2; 100 mg LBS-008 or placebo	Drug: LBS-008; LBS-008 oral capsules; Drug: Placebos; Oral capsules
Experimental: SAD - Cohort 3; 200 mg LBS-008 or placebo	Drug: LBS-008; LBS-008 oral capsules; Drug: Placebos; Oral capsules
Experimental: SAD - Cohort 4; 400 mg LBS-008 or placebo	Drug: LBS-008; LBS-008 oral capsules; Drug: Placebos; Oral capsules
Experimental: SAD - Cohort 5; 25 mg LBS-008 or placebo	Drug: LBS-008; LBS-008 oral capsules; Drug: Placebos; Oral capsules
Experimental: MAD - Cohort 1; 10 mg LBS-008 or placebo	Drug: LBS-008; LBS-008 oral capsules; Drug: Placebos; Oral capsules
Experimental: MAD - Cohort 2; 25 mg LBS-008 or placebo	Drug: LBS-008; LBS-008 oral capsules; Drug: Placebos; Oral capsules
Experimental: MAD - Cohort 3; 5 mg LBS-008 or placebo	Drug: LBS-008; LBS-008 oral capsules; Drug: Placebos; Oral capsules
Experimental: MAD - Cohort 4; 12 mg LBS-008 or placebo	Drug: LBS-008; LBS-008 oral capsules; Drug: Placebos; Oral capsules

Outcome Measures

Primary Outcome Measures :

1. 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 ]
2. 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 ]
3. Maximum observed plasma concentration (Cmax) [ Time Frame: SAD portion: Day 1 to Day 6; MAD portion: Day 1 to Day 28 ]
4. Time to maximum observed plasma concentration (Tmax) [ Time Frame: SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28 ]
5. Terminal elimination rate constant [ Time Frame: SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28 ]
6. Terminal phase half-life (t1/2) [ Time Frame: SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28 ]
7. Apparent total body clearance (CL/F) [ Time Frame: SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28 ]
8. Apparent volume of distribution (Vz/F) [ Time Frame: SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28 ]
9. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Australia

Linear Clinical Research

Perth, Australia, 6009

Sponsors and Collaborators

RBP4 Pty Ltd

Belite Bio, Inc

More Information

• Responsible Party: RBP4 Pty Ltd
• ClinicalTrials.gov Identifier: NCT03735810
• Other Study ID Numbers: LBS-008-CT01
• First Posted: November 8, 2018
• Last Update Posted: January 7, 2020
• Last Verified: August 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: 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.

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes