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

NCT05278611 | Unknown Phase 1

• 1 other identifier: EP-9001A-Ia
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Number and severity of Adverse Events，MTD

  All adverse events occurring throughout the study were assessed and graded. the maximum tolerated dose (MTD)

  Baseline to week 8

Secondary Outcomes (2)

• pharmacokinetics of EP-9001A

  Baseline to week 8

• immunogenicity assessed by ADA

  Baseline to week 8

Study Arms (2)

EP-9001A

EXPERIMENTAL

Dose-escalation trial

Drug: EP-9001A

Placebo

PLACEBO COMPARATOR

Dose-escalation trial

Drug: placebo

Interventions

EP-9001A DRUG

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

Also known as: NGF mab

EP-9001A

placebo DRUG

placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female Chinese volunteers ≥18 and ≤45 years of age at the screening visit;
• Body weight ≥ 45.0 kg for female subjects and ≥ 50.0 kg for male subjects with a body mass index (BMI) between 19.0 and 26.0 kg/m2( including border value);
• Subjects during the trial (female subjects from 14 days before dosing, male subjects from dosing) to 3 months after the end of the trial without fertility or sperm/egg donation plan and voluntarily take effective physical contraception measures;
• According to the results of physical examination, vital signs, ECG and clinical laboratory tests during the screening period, all the test results are normal or abnormal without clinical significance as judged by the investigator;
• Signed a written informed consent.

You may not qualify if:

• history of allergic diseases (including but not limited to asthma, urticaria, allergic rhinitis), or a history of drug allergy, or a history of allergy to the test drug ingredients;
• history of clinical serious diseases and not cured, such as motor (muscle and bone) system, digestive system, respiratory system, genitourinary system, blood (hematopoietic) system, circulatory system, nervous system, mental system, endocrine system, cardiovascular system and metabolic abnormalities;
• received surgery in the past 3 months or have surgery plan during the trial ;
• Have used any prescription, over-the-counter or health care products in the past 2 weeks;
• took more than 10 cigarettes a day or the same amount of tobacco or can not stop tobacco during trial;
• alcohol breath test positive;
• History of alcohol abuse within the past 6 months;
• History of drug abuse, positive results of urine multiple drug tests;
• Drink excessive tea, grapefruit juice, coffee or caffeinated beverages (an average of more than 8 cups per day, 200 mL per cup) every day in the past 1 month;
• Participated in other drug clinical trials in the past 3 months, or plan to participate in other clinical trials during this study;
• Blood loss/blood donation of more than 400 mL in the past 3 months (except for female physiological blood loss), or receiving blood transfusion or use of blood products, or planning to donate blood during the trial or within 1 month after the end of the trial;
• Vaccinated within the past 1 month
• positive in Hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus antibody, syphilis specific antibody screening;
• Subjects who are lactating, pregnant or plan to become pregnant or conceive recently;
• Patients with a history of bone or joint diseases, including but not limited to osteoarthritis, pathological fractures, osteonecrosis, rheumatoid arthritis, neuropathic arthritis, lupus erythematosus or inflammatory joint diseases;

Sponsors & Collaborators

• Chengdu Easton Biopharmaceuticals Co,Ltd: lead

Study Sites (1)

West China Hospital，Sichuan University

Chengdu, Sichuan, China

RECRUITING

Central Study Contacts

ping feng, MD

CONTACT

+86 153 8821 6625; 617130961@qq.com

Study Design

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

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: March 14, 2022
• Study Start: March 23, 2022
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2022
• Last Updated: April 4, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)