First in Human Study of EI-001 Monoclonal Antibody in Healthy Volunteers

Elixiron Immunotherapeutics (Hong Kong) Ltd.

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: EI-001; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04994912

EI-001-101

Details and patient eligibility

About

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.

Full description

To assess the safety and tolerability of single ascending intravenous (IV) doses of EI-001 in healthy volunteers

To assess the pharmacokinetics (PK) of single ascending IV doses of EI-001 in healthy volunteers

Enrollment: 35 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male or female 18 to ≤ 55 years old at the time of consent.
2. 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.

Exclusion criteria

1. 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.
2. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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35 participants in 2 patient groups, including a placebo group

EI-001

Experimental group

Description:

IV infusion

Treatment:

Drug: EI-001

Placebo

Placebo Comparator group

Description:

IV infusion

Treatment:

Other: Placebo