Safety and tolerability Phase I study of LBS-008 in healthy adult subjects after single and multiple doses

Phase 1

Completed

• Conditions: Dry age-related macular degeneration; Eye - Normal eye development and function

• Registration Number: ACTRN12618001823268
• Lead Sponsor: RBP4 Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-09
• Study Completion: 2019-09-16
• Last Update Posted: 8 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 71

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the safety and tolerability to LBS-008, access by adverse events, clinical laboratory test result, vital sign measurement, physical examination and 12-lead ECG result.[Monitored daily through Day 8 for SAD; Monitored daily through Day 21 for MAD.];To evaluate the ocular safety by access the slit lamp biomicroscopy, dilated ophthalmoscopy, and intraocular pressure, visual acuity and color vision result.[Monitored daily through day 2 and day 8 of SAD; Monitored on Day 2, 7, 16 and 21 of MAD.<br>];Pharmacokinetics (PK) parameters (AUC0-t, AUC0-inf, Cmax, Tmax, lambda z, t1/2, CL/F, and Vz/F) of administration of LBS-008 subjects.[Blood PK will be collected at Day 1, 2, 3, 4, 5, 6 and 8 after IP administration of SAD. Blood PK will be collected at Day 1, 2, 3, 4, 7, 11, 14, 15, 16, 17, 18, 19, 21 and 28 for MAD after IP administration.<br>]

Secondary Outcome Measures

Name	Time	Method
1. To determine the effects of LBS-008 on plasma levels of RBP4, a PD marker.[Blood collection of RBP4 for SAD will be on Day 1, 2, 3, 4, 5, 6 and 8 after IP administration and on day 1, 2, 3, 4, 7, 11, 14, 15, 16, 17, 18, 19, 21 and 28 for MAD after IP administration.<br>]