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

A Randomized, Double-blind, Placebo-controlled Dose Escalation Phase Ia Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of EP-9001A Injection in Healthy Subjects

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: placebo; Drug: EP-9001A

Detailed Description

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.

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

• Study Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: ping feng, MD; Phone Number: +86 153 8821 6625; Email: 617130961@qq.com

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China
      • Recruiting
      • West China Hospital,Sichuan University
      • Contact: ping feng, MD; Phone Number: +86 153 8821 6625; Email: 617130961@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy male or female Chinese volunteers ≥18 and ≤45 years of age at the screening visit;
2. 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);
3. 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;
4. 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;
5. Signed a written informed consent.

Exclusion Criteria:

1. 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;
2. 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;
3. received surgery in the past 3 months or have surgery plan during the trial ;
4. Have used any prescription, over-the-counter or health care products in the past 2 weeks;
5. took more than 10 cigarettes a day or the same amount of tobacco or can not stop tobacco during trial;
6. alcohol breath test positive;
7. History of alcohol abuse within the past 6 months;
8. History of drug abuse, positive results of urine multiple drug tests;
9. 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;
10. Participated in other drug clinical trials in the past 3 months, or plan to participate in other clinical trials during this study;
11. 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;
12. Vaccinated within the past 1 month
13. positive in Hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus antibody, syphilis specific antibody screening;
14. Subjects who are lactating, pregnant or plan to become pregnant or conceive recently;
15. 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;
16. Patients with a history of joint-related events, such as total joint replacement (TJR) surgery, meniscus or knee ligament injury (with or without surgical repair) or joint infection, or bone dislocation, hip dislocation, knee dislocation within 1 year before screening;
17. Kellgren-Lawrence grade ≥ 2 in any major joint (shoulder, hip, knee);
18. History of clinically significant peripheral neuropathy, paresthesia, dysesthesia;
19. History of autonomic neuropathy or diabetic neuropathy;
20. The investigator assesses the poor compliance, or the investigator believes that the subject has any other conditions that are not suitable for participating in this clinical study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Dose-escalation trial	Drug: placebo; placebo
Experimental: EP-9001A; Dose-escalation trial	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; Other Names: NGF mab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
pharmacokinetics of EP-9001A	EP-9001A serum concentrations over time	Baseline to week 8
immunogenicity assessed by ADA	Presence of anti-drug antibodies over time	Baseline to week 8

Collaborators and Investigators

• Sponsor: Chengdu Easton Biopharmaceuticals Co,Ltd

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2022
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: March 4, 2022
• First Submitted That Met QC Criteria: March 4, 2022
• First Posted (Actual): March 14, 2022

Study Record Updates

• Last Update Posted (Actual): April 4, 2022
• Last Update Submitted That Met QC Criteria: March 30, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: EP-9001A-Ia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No