Healthy VolunteersPhase 1NCT05278611
a Safety and Tolerability Study of EP-9001A in Healthy Volunteers
A Phase 1 study testing EP-9001A in people with Healthy Volunteers, run by Chengdu Easton Biopharmaceuticals Co,Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- EP-9001A
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 23 Mar 2022to Dec 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital，Sichuan University
Chengdu, Sichuan
ping feng, MD, +86 153 8821 6625, 617130961@qq.com
About this study
Official title: 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.
Read the 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
- Conditions
- Healthy Volunteers
- Being tested
- EP-9001A, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EP-9001ADrug
Also called NGF mab
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
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| EP-9001A | Experimental | Dose-escalation trial Receives: Drug: EP-9001A |
| Placebo | Placebo comparator | Dose-escalation trial Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and severity of Adverse Events，MTD
All adverse events occurring throughout the study were assessed and graded. the maximum tolerated dose (MTD)
Measured: Baseline to week 8
Secondary outcomes (2)
pharmacokinetics of EP-9001A
EP-9001A serum concentrations over time
Measured: Baseline to week 8
immunogenicity assessed by ADA
Presence of anti-drug antibodies over time
Measured: Baseline to week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start23 Mar 2022
- Primary completionSep 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu Easton Biopharmaceuticals Co,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05278611
- Sponsor's protocol ID
- EP-9001A-Ia
- Status last verified
- Mar 2022
- First submitted
- 4 Mar 2022
- Last updated
- 4 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05278611
- Acronym / sponsor ID
- EP-9001A-Ia
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Chengdu Easton Biopharmaceuticals Co,LtdIndustry (pharma, biotech, devices)
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 14 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EP-9001A | Experimental | Drug: EP-9001ADose-escalation trial |
| Placebo | Placebo comparator | Drug: placeboDose-escalation trial |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (20 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EP-9001AAlso: NGF mabThe 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 | EP-9001A |
| placeboplacebo | Drug | Placebo |
Primary outcome
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)
2 secondary outcomes
pharmacokinetics of EP-9001A
Time frame: Baseline to week 8
immunogenicity assessed by ADA
Time frame: Baseline to week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EP-9001A in people with Healthy Volunteers, run by Chengdu Easton Biopharmaceuticals Co,Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ping feng, MD (+86 153 8821 6625, 617130961@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and severity of Adverse Events，MTD (time frame: Baseline to week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2022.