NCT04994912

Brief Summary

A First-in-Human, Phase 1, Randomized, Double-Blind, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of EI-001 in Healthy Volunteers.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Oct 2021

Longer than P75 for phase_1 healthy

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 6, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2025

Completed
Last Updated

June 24, 2025

Status Verified

June 1, 2025

Enrollment Period

3.3 years

First QC Date

July 19, 2021

Last Update Submit

June 18, 2025

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

  • safety assessment

    to assess blood pressure

    Day 1

  • safety assessment

    to assess heart rate

    Day 1

  • safety assessment

    to assess respiratory rate

    Day 1

Secondary Outcomes (3)

  • PK assessment

    Day 1

  • PK assessment

    Day 1

  • PK assessment

    Day 1

Study Arms (2)

EI-001

EXPERIMENTAL

IV infusion

Drug: EI-001

Placebo

PLACEBO COMPARATOR

IV infusion

Other: Placebo

Interventions

EI-001DRUG

EI-001 IV infusion

EI-001
PlaceboOTHER

Placebo IV infusion

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male or female 18 to ≤ 55 years old at the time of consent.
  • Healthy on the basis of physical examination, medical history, vital signs, laboratory values and 12-lead ECG performed at Screening. The participant may be included only if the investigator judges any abnormalities or deviations from normal to be not clinically significant.

You may not qualify if:

  • Prior or ongoing medical conditions, medical history, physical findings, or laboratory abnormality that, in the Investigator's (or delegate's) opinion, may require treatment or render the participant unlikely to fully complete the study, or any condition that presents undue risk from the IP or procedures or interfere with study assessments.
  • Have received any IP within 30 days or 5 half-lives prior to Screening (4 months if the previous drug was a new chemical entity), whichever is longer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nucleus Network Pty Ltd

Melbourne, Victoria, 3004, Australia

Location

Huashan Hospital of Fudan University

Shanghai, China

Location

MeSH Terms

Interventions

BL-EI001

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2021

First Posted

August 6, 2021

Study Start

October 1, 2021

Primary Completion

January 7, 2025

Study Completion

February 18, 2025

Last Updated

June 24, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)CN(1)