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

  • STATUS
    Recruiting
  • End date
    Dec 19, 2022
  • participants needed
    44
  • sponsor
    Chengdu Easton Biopharmaceuticals Co,Ltd
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Updated on 19 April 2022
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Accepts healthy volunteers

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.

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

Details
Condition Healthy Volunteers
Treatment Placebo, EP-9001A
Clinical Study IdentifierNCT05278611
SponsorChengdu Easton Biopharmaceuticals Co,Ltd
Last Modified on19 April 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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
Kellgren-Lawrence grade ≥ 2 in any major joint (shoulder, hip, knee)
History of clinically significant peripheral neuropathy, paresthesia, dysesthesia
History of autonomic neuropathy or diabetic neuropathy
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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