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
Overview
- Phase
- Phase 1
- Intervention
- placebo
- Conditions
- Healthy Volunteers
- Sponsor
- Chengdu Easton Biopharmaceuticals Co,Ltd
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Number and severity of Adverse Events，MTD
- Last Updated
- 4 years ago
Overview
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.
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
Investigators
Eligibility Criteria
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;
Arms & Interventions
Placebo
Dose-escalation trial
Intervention: placebo
EP-9001A
Dose-escalation trial
Intervention: EP-9001A
Outcomes
Primary Outcomes
Number and severity of Adverse Events，MTD
Time Frame: Baseline to week 8
All adverse events occurring throughout the study were assessed and graded. the maximum tolerated dose (MTD)
Secondary Outcomes
- pharmacokinetics of EP-9001A(Baseline to week 8)
- immunogenicity assessed by ADA(Baseline to week 8)