Pharmacokinetics and Pharmacodynamics Study of LBS-008 in Healthy Volunteers Aged 50-85

• Status: Not yet recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 1b, parallel single-dose study to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of Tinlarebant when administered as an oral dose to elderly healthy volunteers. This study will evaluate 2 dose levels in 2 cohorts comprising up to a total of 16 participants (8 per cohort). Dose levels will be evaluated in parallel.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: RBP4 Pty Ltd
• Collaborator: Belite Bio, Inc

Criteria

Key inclusion criteria:

1. Must have given written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects.

2. Healthy adult male or female, or adult male or female with a stable chronic disease or condition aged 50-85 years of age, inclusive. Adults with stable chronic disease or condition includes adults with no new diagnosis, hospitalisation or changes in medication in the 3 months prior to first dose of study drug on Day 1. Ongoing concomitant medications associated with the stable disease or condition, including over-the-counter (OTC) medications and herbal/vitamin supplements taken by volunteers, will be recorded and reviewed by the PI (or delegate) to determine whether the volunteer is suitable for inclusion in the study. In conducting this review, the PI (or delegate) must consider Exclusion Criteria 11, 12, 13 and 14.

3. The volunteer is considered by the Investigator to be in stable health

Key exclusion criteria :

1. Presence of CS cardiovascular, pulmonary, hepatic, renal, haematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease, or any other condition that, in the opinion of the Investigator, would jeopardise the safety of the participant or the validity of the study results.

2. Had a CS new illness within 1 month prior to the screening visit, with the exception of fully resolved gastrointestinal illness at least 14 days prior to the screening visit, fully resolved minor colds (e.g., only cold and flu-like symptoms) that occurred within 1 month prior to the screening visit, and fully resolved corona virus disease 2019 (COVID-19) infections if resolved at least 14 days prior to the screening visit and 30 days prior to confinement to the clinical facility.

3. A history of uncontrolled hypertension, coronary artery disease, or any other significant cardiovascular disease.

4. A history of uncontrolled diabetes. Volunteers with fully resolved gestational diabetes will be eligible to participate in the study.

5. A history of unexplained loss of consciousness, epilepsy or other seizure disorder, or cerebrovascular disease.