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Completed

NCT Number: NCT03735810

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

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.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Linear Clinical Research

Perth, 6009, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LBS-008

Drug

LBS-008 oral capsules

Placebos

Drug

Oral capsules

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

RBP4 Pty Ltd

Industry

Collaborators

  • Belite Bio, Inc

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 8, 2018
Registry last updated
Jan 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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