NCT07256288

A Phase Ia Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of EA5 in Healthy Adult Subjects

A Single-Center, Double-Blind, Placebo-Controlled, Dose-Escalating Phase Ia Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Characteristics of EA5 in a Single Dose in Adult Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Shanghai Lanyi Therapeutics Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a single-center, double-blind, placebo-controlled, dose-escalating Phase Ia clinical study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of a single dose of EA5 in healthy adult subjects.

Detailed description

The study plans to enroll up to 28 subjects. Its primary purpose is to conduct a preliminary assessment of the exposure, safety, and pharmacokinetic profile of EA5 in humans, thereby informing the confirmation or adjustment of the formal trial design. The trial is structured into a pilot phase and a formal phase, encompassing a total of five planned dose cohorts: the pilot trial involves two dose groups (90 mg and 180 mg), each with 2 subjects receiving the active drug; the formal trial consists of three dose groups (360 mg, 720 mg, and 1440 mg), where participants are randomized in a 3:1 ratio (6 subjects receiving the active drug EA5 and 2 subjects receiving placebo per cohort), administered via intravenous (IV) infusion.A 57-day observation period was performed for safety, pharmacokinetic, and pharmacodynamic assessments after study drug administration. Antidrug antibody (ADA) levels were monitored in study participants for the duration of the 57-day follow-up period.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	EA5	All doses of EA5 were administered by IV infusion, using programmable IV infusion pump and IV sets with in-line filters.
DRUG	Placebo	All doses of placebo were administered by IV infusion, using programmable IV infusion pump and IV sets with in-line filters.

Timeline

• Start date: 2023-05-31
• Primary completion: 2024-08-01
• Completion: 2024-08-01
• First posted: 2025-12-01
• Last updated: 2025-12-01

Locations

1 site across 1 country: China