None listed
Conditions
Brief summary
A double-blind, placebo-controlled, single ascending dose (SAD) study is planned to assess safety, pharmacokinetics (PK), and pharmacodynamics of LBS-008 in healthy adult volunteers. Healthy male or female adults with no significant ocular abnormalities will be enrolled. The plan is to enroll 40 subjects, in five cohorts of eight subjects each; additional cohorts (eight subjects per cohort) may be enrolled if it is deemed appropriate by the sponsor to repeat a dose level or to study another dose level. Within each cohort, six subjects will be randomized to receive active drug and two subjects will receive placebo. Each subject will participate in only one dose level. Subjects will receive single ascending doses of 50, 100, 200, 400, and 25 mg LBS-008 administered as 25 or 200 mg capsules, or an equivalent number of placebo capsules. Each dose cohort will be separated into two groups; a sentinel group of two subjects (one active and one placebo) will be dosed at least 24 hours before the remaining six subjects (five active and one placebo). The MAD portion will start after the completion of Cohort 4 of SAD and will have up to 4 cohorts and up to a total of 32 subjects (8 subjects per cohort). The starting dose of LBS-008 will be 10 mg and the planned doses for subsequent cohorts are 25, 5 and 12 mg. The final doses are determined based on the outcome of SAD portion.
Interventions
The Single Ascending Dose (SAD) portion will have up to 5 cohorts and up to a total of 40 subjects (8 subjects per cohort). The starting dose of LBS-008 will be 50 mg and the planned doses for subsequent cohorts are 100, 200, 400 mg. An additional cohort at 25 mg dose level is determined to further evaluate the safety, PK and PD profile of LBS-008.
The Multiple Ascending Dose (MAD) portion will start after the completion of Cohort 4 of SAD and will have up to 4 cohorts and up to a total of 32 s
The Single Ascending Dose (SAD) portion will have up to 5 cohorts and up to a total of 40 subjects (8 subjects per cohort). The starting dose of LBS-008 will be 50 mg and the planned doses for subsequent cohorts are 100, 200, 400 mg. An additional cohort at 25 mg dose level is determined to further evaluate the safety, PK and PD profile of LBS-008. The Multiple Ascending Dose (MAD) portion will start after the completion of Cohort 4 of SAD and will have up to 4 cohorts and up to a total of 32 subjects (8 subjects per cohort). The starting dose of LBS-008 will be 10 mg and the planned doses for subsequent cohorts are 25, 5 and 12 mg. The final doses are determined based on the outcome of SAD portion. Route of administration: Oral Duration: SAD on Day 1 and MAD from day 1 to day 14 The strategies used to monitor adherence to the study drug will be: administration under direct medical supervision, mouth inspection for checking the ingestion, appropriate record of the dosing information, counts of the number of capsules.
Sponsors
RBP4 Pty Ltd
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1.The subject is male or female, 18 to 65 years of age, inclusive, at screening. 2. The subject voluntarily consents to participate in this study and provides written informed consent before the start of any study-specific procedures. 3. 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. 4. 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. 5. 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. 6. 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. 7. The subject is considered to be in stable health by the investigator. 8. The subject agrees to comply with all protocol requirements.
Exclusion criteria
1.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. 2. Vitamin A deficiency. 3. Any recent viral or bacterial infection. 4. Participated in any clinical study in last 6 weeks. 5. History of significant drug allergy 6. History of significant vision, ocular or retinal disorder. 7. Recent surgery, blood transfusion, drug or alcohol abuse and use of tobacco or nicotine containing products in past month. 8. 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.
Outcome results
None listed