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

NCT07256288 | Completed Phase 1 DMC

• 1 other identifier: C-EA5-2301
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs)

  TEAEs were defined as AEs that occurred on or after the date and time of study drug administration, or those that first occurred before dosing but worsened in frequency or severity after study drug administration. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.

  Baseline up to Day 57

Secondary Outcomes (11)

• Maximum Observed Serum Concentration (Cmax) of EA5

  30 minutes predose, 5 minutes, 1, 2, 6, 24, hours postdose, then at Days 3, 4, 8, 15, 29, 43, 57

• Time To Maximum Observed Serum Concentration (Tmax) of EA5

  30 minutes predose, 5 minutes, 1, 2, 6, 24, hours postdose, then at Days 3, 4, 8, 15, 29, 43, 57

• Area Under The Serum Concentration Versus Time Curve From Time Zero To The Time of The Last Quantifiable Concentration (AUC0-t) of EA5

  30 minutes predose, 5 minutes, 1, 2, 6, 24, hours postdose, then at Days 3, 4, 8, 15, 29, 43, 57

• Area Under The Serum Concentration Versus Time Curve From Time Zero (Dosing) To Infinity (AUCinf) of EA5

  30 minutes predose, 5 minutes, 1, 2, 6, 24, hours postdose, then at Days 3, 4, 8, 15, 29, 43, 57

• Terminal Elimination Rate Constant (λz) of Serum EA5

  30 minutes predose, 5 minutes, 1, 2, 6, 24, hours postdose, then at Days 3, 4, 8, 15, 29, 43, 57

Study Arms (6)

EA5 90mg

EXPERIMENTAL

EA5 was administered intravenously.

Drug: EA5

EA5 180mg

EXPERIMENTAL

EA5 was administered intravenously.

Drug: EA5

EA5 360mg

EXPERIMENTAL

EA5 was administered intravenously.

Drug: EA5; Drug: Placebo

EA5 720mg

EXPERIMENTAL

EA5 was administered intravenously.

Drug: EA5; Drug: Placebo

EA5 1440mg

EXPERIMENTAL

EA5 was administered intravenously.

Drug: EA5; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Placebo was administered intravenously.

Drug: EA5

Interventions

EA5 DRUG

All doses of EA5 were administered by IV infusion, using programmable IV infusion pump and IV sets with in-line filters.

EA5 1440mg; EA5 180mg; EA5 360mg; EA5 720mg; EA5 90mg; Placebo

Placebo DRUG

All doses of placebo were administered by IV infusion, using programmable IV infusion pump and IV sets with in-line filters.

EA5 1440mg; EA5 360mg; EA5 720mg

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy subjects aged 18 to 55 years (inclusive), regardless of gender.
• Body weight ≥50 kg (male) or ≥45 kg (female), and a body mass index (BMI) between 18 and 28 kg/m² (inclusive).
• Must have received the meningococcal polysaccharide vaccine MenACWY (containing serogroups A, C, W, and Y) at least two weeks prior to dosing.
• Subjects must be able to communicate effectively with the investigator and are expected to comply with the study procedures as defined in the protocol.
• Subjects must be in good general health, as judged by the investigator based on medical history, physical examination, vital signs, electrocardiogram (ECG), chest X-ray, abdominal ultrasound, and laboratory test results.
• Male subjects agree to use effective contraception (vasectomy, abstinence, or condom) from screening until 6 months after the final study intervention. Female subjects must have a negative blood pregnancy test at screening and baseline. Throughout the study and for 6 months thereafter, all subjects and their partners (if of childbearing potential) must use highly effective non-pharmacological contraception.
• Subjects must provide written informed consent voluntarily before any study-specific procedures are performed.
• Systolic and diastolic blood pressure must be within the normal range, or exhibit abnormalities deemed clinically insignificant by the investigator.

You may not qualify if:

• History of severe drug allergy; or a clear history of allergy and/or known allergy to the investigational product or any of its excipients, which in the opinion of the investigator, renders the subject unsuitable for participation in the study.
• Prior history of splenectomy.
• History of pulmonary tuberculosis.
• Congenital or acquired complement deficiency (e.g., hypocomplementemia).
• Any contraindication to antibiotic prophylaxis (e.g., beta-lactam antibiotics, ciprofloxacin) for meningococcal infection
• Positive test for hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, treponemal antibody (TP-Ab), or hepatitis B virus (HBV) surface antigen (HBsAg) at screening
• Presence of symptoms or a significant history of any major disease, including but not limited to cardiac, hepatic, renal, other acute or chronic gastrointestinal or respiratory diseases; hematological, endocrine, neurological, psychiatric disorders; or any other disease or physiological condition that could interfere with the interpretation of the study results.
• Participation in any clinical trial involving an investigational drug or medical device within 3 months prior to screening, or within 5 half-lives of the previous investigational drug prior to screening (whichever is longer)
• Blood loss or donation \> 400 mL within 3 months prior to screening, or \> 200 mL within 4 weeks prior to screening, or intention to donate blood during the study period
• Average cigarette smoking of ≥5 cigarettes per day within 3 months prior to the study
• Alcohol abuse or regular alcohol consumption exceeding 14 units per week within 6 months prior to screening (1 unit ≈ 360 mL beer, 45 mL 40% spirits, or 150 mL wine), or a positive alcohol breath test at screening.
• History of drug abuse or a positive urine drug screen at screening
• Undergone surgery or received blood or blood product transfusion within 1 month prior to screening。
• Administration of any live or live-attenuated vaccine within 1 month prior to the first dose。
• Use of any prescription drugs, over-the-counter medications, herbal medicines, or vitamins within 14 days or 5 half-lives (whichever is longer) prior to screening。

Sponsors & Collaborators

• Shanghai Lanyi Therapeutics Co., Ltd.: lead

Study Sites (1)

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230601, China

Location

Study Officials

• Wei Hu, Professor

  The Second Hospital of Anhui Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 1, 2025
• Study Start: May 31, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: December 1, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)