NCT04620109

Clinical Evaluation of Safety and Tolerability of KDR2-2 Eye Drops in Healthy Volunteers With Pharmacokinetic Assessment

A Phase 1 Randomized, Double Blinded, Placebo-Controlled Single Dose and Repeat Dose Escalation Study to Evaluate Safety and Tolerability and Pharmacokinetic Characteristics of KDR2-2 in Adult Healthy Male and Female Volunteers

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: Guangzhou HuiBoRui Biological Pharmaceutical Technology Co. Ltd · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A Phase 1 randomized, double blinded, placebo-controlled, single dose escalation (SDE) and repeat dose escalation (RDE) study to evaluate safety and tolerability, and PK of KDR2-2 in healthy volunteers. The planned single dose levels are 0.03, 0.06, 0.12, and 0.24 mg/eye, and repeat dose levels are 0.06, 0.12, and 0.24 mg/eye, QID, × 6 days (one dose in the morning on Day 7). Subjects are randomized to KDR2-2 or placebo dosing (6:2 for SDE, or 8:2 for RDE) in each cohorts of relative dosing levels.

Detailed description

This is a Phase 1 randomized, double blinded, placebo-controlled, single dose and repeat dose escalation study to evaluate safety and tolerability, and PK of KDR2-2 in healthy volunteers. The trial will include a screening period, a treatment period, and a follow-up period of 7 days for single dose escalation (SDE) or repeat dose escalation (RDE) after last administration. The screening period will be up to 28 days prior to investigational product administration. The screening process will initiate upon completion of the informed consent process. Once consent is provided by each participant, a thorough screening process will take place, including detailed medical history, physical examination and ophthalmology examination, vital signs, concomitant medications, safety labs, 12 lead electrocardiogram, serum pregnancy test, urinalysis, serology panel, assessment of inclusion and exclusion criteria. Upon completion of the screening, qualified subjects will be randomized to KDR2-2 or placebo (6:2 for SDE, or 8:2 for RDE). Each enrolled subject will receive one single or repeat assigned dose of KDR2-2 or placebo. The investigator and subjects will be blinded to treatment assignment. During the study, subjects will be evaluated for safety and tolerability, and PK of KDR2-2. In each cohort, a sentinel group of two subjects will be dosed first: one sentinel with KDR2-2, and the other with the placebo. The remaining subjects of the same cohort will be dosed at least 24 hours after sentinel dosing with approval from the principal investigator upon assessing the sentinel group. KDR2-2 or placebo will be topically administered in the right eye as a single or repeat instillation on Day 1. Subjects will have end-of-study (EOS) follow-up visits on Day 8 (±1) for SDE or Day 15 (±1) for RDE. The planned single dose levels are 0.03, 0.06, 0.12, and 0.24 mg/eye, and repeat dose levels are 0.06, 0.12, and 0.24 mg/eye, QID, × 6 days (one dose in the morning on Day 7). The Starting dose of KDR2-2 in repeat dose escalation stage will be at least 2 dose levels below the highest single dose level shown to be safe, for example, if 0.24 mg is proven to be safe during SDE, the starting dose during RDE will be 0.06 mg. Other higher dose level(s) might be optional based on emerging data from this study.

Conditions

• Corneal Neovascularization

Interventions

Type	Name	Description
DRUG	KDR2-2	KDR2-2 is a synthetic anti-angiogenic chemical compound with highly effective inhibition on vascular endothelial growth factor receptor-2 (VEGFR2), and an additional, moderate inhibitory effect on platelet-derived growth factor receptor β (PDGFRβ). KDR2-2 suspension eye drop is in development for the treatment of corneal neovascularization.
DRUG	Placebo	Placebo : the formulation and the product process of placebo are the same as the KDR2-2 eye drops, but without API .

Timeline

• Start date: 2020-08-26
• Primary completion: 2021-03-31
• Completion: 2021-06-30
• First posted: 2020-11-06
• Last updated: 2020-11-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study