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

NCT07256288 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2025-12-01

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers

Interventions

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.

Sponsors & Collaborators

  • Shanghai Lanyi Therapeutics Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Wei Hu, Professor · The Second Hospital of Anhui Medical University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-31
Primary Completion
2024-08-01
Completion
2024-08-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07256288 on ClinicalTrials.gov