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Trial record 1 of 1 for:    LBS-008
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Safety and Tolerability Study of LBS-008 in Healthy Adult Subjects After Single and Multiple Doses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03735810
Recruitment Status : Completed
First Posted : November 8, 2018
Last Update Posted : January 7, 2020
Sponsor:
Collaborator:
Belite Bio, Inc
Information provided by (Responsible Party):
RBP4 Pty Ltd

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

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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

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




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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03735810


Locations
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Australia
Linear Clinical Research
Perth, Australia, 6009
Sponsors and Collaborators
RBP4 Pty Ltd
Belite Bio, Inc
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Responsible Party: RBP4 Pty Ltd
ClinicalTrials.gov Identifier: NCT03735810    
Other Study ID Numbers: LBS-008-CT01
First Posted: November 8, 2018    Key Record Dates
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.

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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