NCT03735810

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 8, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

November 15, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 16, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2019

Completed
Last Updated

January 7, 2020

Status Verified

August 1, 2019

Enrollment Period

10 months

First QC Date

November 7, 2018

Last Update Submit

January 3, 2020

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (9)

  • 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

  • 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

  • Maximum observed plasma concentration (Cmax)

    SAD portion: Day 1 to Day 6; MAD portion: Day 1 to Day 28

  • Time to maximum observed plasma concentration (Tmax)

    SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28

  • Terminal elimination rate constant

    SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28

  • Terminal phase half-life (t1/2)

    SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28

  • Apparent total body clearance (CL/F)

    SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28

  • Apparent volume of distribution (Vz/F)

    SAD portion: Day 1 to Day 8; MAD portion: Day 1 to Day 28

  • 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

Study Arms (9)

SAD - Cohort 1

EXPERIMENTAL

50 mg LBS-008 or placebo

Drug: LBS-008Drug: Placebos

SAD - Cohort 2

EXPERIMENTAL

100 mg LBS-008 or placebo

Drug: LBS-008Drug: Placebos

SAD - Cohort 3

EXPERIMENTAL

200 mg LBS-008 or placebo

Drug: LBS-008Drug: Placebos

SAD - Cohort 4

EXPERIMENTAL

400 mg LBS-008 or placebo

Drug: LBS-008Drug: Placebos

SAD - Cohort 5

EXPERIMENTAL

25 mg LBS-008 or placebo

Drug: LBS-008Drug: Placebos

MAD - Cohort 1

EXPERIMENTAL

10 mg LBS-008 or placebo

Drug: LBS-008Drug: Placebos

MAD - Cohort 2

EXPERIMENTAL

25 mg LBS-008 or placebo

Drug: LBS-008Drug: Placebos

MAD - Cohort 3

EXPERIMENTAL

5 mg LBS-008 or placebo

Drug: LBS-008Drug: Placebos

MAD - Cohort 4

EXPERIMENTAL

12 mg LBS-008 or placebo

Drug: LBS-008Drug: Placebos

Interventions

LBS-008DRUG

LBS-008 oral capsules

MAD - Cohort 1MAD - Cohort 2MAD - Cohort 3MAD - Cohort 4SAD - Cohort 1SAD - Cohort 2SAD - Cohort 3SAD - Cohort 4SAD - Cohort 5
PlacebosDRUG

Oral capsules

MAD - Cohort 1MAD - Cohort 2MAD - Cohort 3MAD - Cohort 4SAD - Cohort 1SAD - Cohort 2SAD - Cohort 3SAD - Cohort 4SAD - Cohort 5

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Linear Clinical Research

Perth, 6009, Australia

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2018

First Posted

November 8, 2018

Study Start

November 15, 2018

Primary Completion

September 16, 2019

Study Completion

September 16, 2019

Last Updated

January 7, 2020

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

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.

Locations

AU(1)