A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Escalating Doses of LH-001 in Healthy Participants
Chien-Liang Lin
Summary
The purpose of this clinical trial is to evaluate the safety and tolerability of LH-001 when administered as an oral, single or multiple dose(s) at ascending dose levels in healthy participants.
Description
This is a first-in-human, randomized, double-blinded, placebo-controlled study. This study consists of two parts: (1) single ascending doses in 4 cohorts (SAD) and (2) 14-day multiple ascending doses in 3 cohorts (MAD). Cohorts may be added or removed if needed due to safety considerations or deviations of actual PK parameters from predicted values. The SAD study consists of a screening visit, a 2-day inpatient stay (Day 1-2), a return visit for safety assessments on Day 3, Day 4, and Day 8. The MAD study consists of a screening visit, a 2-day inpatient stay (Day 1-2), daily return for dosin…
Eligibility
- Age range
- 18–60 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Healthy males or females aged 18-60 years at the time of consent * Must provide written informed consent * Physically and mentally able and willing to participate in the safety and other assessments including staying overnight * BMI 18-29.9 kg/m2 * Sexually active male participants, sexually active female participants of childbearing potential, and their sexual partners are to adhere to the contraception requirements. These requirements include utilizing highly effective birth control (including hormonal methods, intrauterine devices, and/or barrier methods) from the scr…
Interventions
- DrugLH-001
LH-001 will be administered oral
- DrugPlacebo
Placebo will be administered oral
Location
- The Ohio State UniversityColumbus, Ohio