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a Safety and Tolerability Study of EP-9001A in Healthy Volunteers

NCT05278611 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2022-04-04

No results posted yet for this study

Summary

Nerve Growth Factor（NGF）plays an important role in the pathogenesis of neuropathic pain including cancer pain. EP-9001A is a humanized monoclonal antibody targeting NGF, thus thought to alleviate neuropathic pain though the blockade of NGF signal pathway.

The primary objective of the study is to assess the safety and tolerability of a single dose of subcutaneous (SC) administered EP-9001A in healthy Chinese subjects.

Conditions

  • Healthy Volunteers

Interventions

DRUG

EP-9001A

The initial dose of the study was set as 1 mg, and the doses were escalated sequentially in the order of 1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg, and 25 mg

DRUG

placebo

placebo

Sponsors & Collaborators

  • Chengdu Easton Biopharmaceuticals Co,Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-03-23
Primary Completion
2022-09-30
Completion
2022-12-31

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 NCT05278611 on ClinicalTrials.gov