Generalized Myasthenia Gravis (gMG)Phase 1NCT07818291
An Open-label, Dose-escalation Phase Ib Study of EA5 Injection in Adults With Anti-AChR Antibody-Positive Generalized Myasthenia Gravis
A Phase 1 study testing EA5 in people with Generalized Myasthenia Gravis (gMG), run by Shanghai Lanyi Therapeutics Co., Ltd. at 2 sites in China.
Trial summary
This is a Phase Ib, open-label, dose-escalation, single-center/multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of multiple doses of EA5 (a humanized anti-complement C5 monoclonal antibody) in adult participants with anti-AChR… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Generalized Myasthenia Gravis (gMG)
- What is being tested?
- EA5
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesChina
- Study dates
- 15 Sep 2026to 31 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged ≥18 years.
- Diagnosis of myasthenia gravis (MG) confirmed by:
- positive serology for anti-acetylcholine receptor (AChR) antibody at screening; and
- any one of the following: abnormal neuromuscular transmission confirmed by repetitive nerve stimulation; history of positive anticholinesterase test (e.g., neostigmine test); or improvement in MG signs after oral cholinesterase inhibitors as assessed by the treating physician.
- Body weight between 40 kg and 100 kg (inclusive) at screening.
- MGFA clinical classification Class II to IVa at screening.
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- MG-ADL total score ≥5 at screening, with more than 50% of the total score from non-ocular symptoms.
- For participants receiving immunosuppressive therapy (IST) (e.g., azathioprine [AZA], mycophenolate mofetil [MMF], methotrexate [MTX], cyclophosphamide [CY]): treatment for ≥6 months prior to screening and stable dose for ≥2 months (calculated as 30 days per month).
- For participants receiving other IST (e.g., cyclosporine [CsA], tacrolimus [TAC]): treatment for ≥3 months prior to screening and stable dose for ≥1 month.
- For participants receiving corticosteroid therapy at enrollment: stable dose (not exceeding 30 mg/day prednisone acetate or equivalent) for ≥28 days prior to screening.
- For participants receiving cholinesterase inhibitor therapy: stable dose for ≥14 days prior to screening.
- At screening, laboratory tests must meet: (a) Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) <1.5×ULN; (b) serum total bilirubin <1.5×ULN (<3×ULN for confirmed Gilbert's syndrome); (c) Hemoglobin ≥100 g/dL; (d) Platelet count >75×10⁹/L; (e) International normalized ratio (INR) and activated partial thromboplastin time (aPTT) <1.5×ULN; (f) serum creatinine <1.5×ULN and eGFR >90 mL/min/1.73m²; (g) basically normal immune function as assessed by the investigator (lymphocyte count ≥1×LLN, IgG ≥1×LLN).
- To reduce the risk of meningococcal infection (Neisseria meningitidis): participants must be vaccinated at least 14 days prior to the first dose of study drug if not vaccinated within the valid coverage period; if vaccinated within 14 days before dosing, antibiotic prophylaxis must be provided until 2 weeks post-vaccination (penicillin V potassium recommended; cefaclor or other antibiotics may be used if penicillin is unavailable or the participant is allergic; fluoroquinolones and macrolides are not recommended).
- To reduce the risk of pneumococcal infection: vaccination against Streptococcus pneumoniae is required; if previously vaccinated, vaccination may be waived during screening; if not previously vaccinated, vaccination must be given at least 14 days prior to the first dose (antibiotic prophylaxis as described in item 11).
- For females of childbearing potential: serum β-HCG pregnancy test must be negative at screening; effective and reliable contraception must be used during the study and for at least 6 months after discontinuation of study intervention (women of childbearing potential are defined as premenopausal women who have not undergone sterilization; menopause is defined as amenorrhea for ≥12 months without alternative medical measures; FSH >40 mIU/mL confirms menopause).
- Male participants must agree to use effective contraceptive measures (vasectomy, abstinence, condom use) throughout the study period (from screening to 6 months after study completion); female participants of childbearing potential must have negative blood pregnancy tests at screening and baseline, and female participants, male participants, and their sexual partners must agree to use contraceptive measures during the study and for 6 months after completion (both pharmacological and non-pharmacological methods are acceptable).
- Capable of understanding the study procedures and methods, willing to sign the Informed Consent Form (ICF), and able to strictly adhere to the clinical study protocol to complete the study.
Who cannot join
- Presence of untreated thymic epithelial tumors (including all types of thymoma or thymic carcinoma), extrathymic germ cell tumor, or other malignant mediastinal masses at the screening visit; or, as judged by the investigator, presence of thymic cysts or other space-occupying lesions requiring immediate intervention.
- History of thymectomy or any other thymic surgery within 12 months prior to screening, or planned thymectomy during the trial period.
- Prior history of thymic tumor is permitted for enrollment only if the subject meets all criteria in either of the following risk groups:
- Low recurrence risk group: Subjects with histopathologically confirmed thymoma of Masaoka-Koga stages I-II (WHO types A, AB, B1, or B2) who meet all of the following criteria are eligible for enrollment in this study:
- Curative treatment (e.g., R0 surgical resection) completed ≥ 12 months prior to the screening visit;
- No clinical evidence of recurrence within 12 months prior to screening;
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- No radiological evidence of recurrence confirmed by contrast-enhanced chest CT or MRI within 6 months prior to randomization.
- High recurrence risk group: Subjects with histopathologically confirmed thymic carcinoma (WHO type C) or Masaoka-Koga stages III-IV thymoma (including WHO type B3) who meet all of the following criteria are eligible for enrollment:
- Curative treatment (surgery with or without radiotherapy/chemotherapy and other combined-modality therapy) completed > 5 years prior to the screening visit;
- No clinical evidence of recurrence within 5 years;
- No evidence of recurrence or distant metastasis confirmed by contrast-enhanced chest CT or MRI within 6 months prior to randomization.
- [Note: If a participant cannot provide complete original histopathology reports or Masaoka-Koga staging records, they must be evaluated according to the high recurrence risk group criteria (i.e., treatment completed > 5 years with no evidence of recurrence).]
- Weakness involving only ocular or periorbital muscles (MGFA Class I).
- Occurrence of MG crisis (MGFA Class V) within 6 months prior to screening.
- Known positive serology for muscle-specific receptor tyrosine kinase (MuSK) or lipoprotein receptor-related protein 4 (LRP4), or negative results for both anti-AChR and anti-MuSK antibodies.
- Pregnant, lactating, or planning to become pregnant during the study period.
- Any systemic bacterial infection or other infection deemed clinically significant by the investigator, or requiring intravenous antibiotic therapy within 28 days prior to the first dose.
- Positive for hepatitis C virus (HCV) antibody at screening (except for those with negative HCV RNA); positive for human immunodeficiency virus (HIV) antibody; positive for anti-Treponema pallidum antibody (TP-Ab) (except for those with negative RPR or TRUST); or positive for hepatitis B virus (HBV) surface antigen (HBsAg) and/or HBV core antibody (HBcAb) with HBV-DNA above the upper limit of detection.
- History of Neisseria meningitidis infection or unresolved meningococcal disease within 6 months prior to screening up to first dose.
- Body temperature ≥38°C within 7 days prior to first treatment.
- Use of intravenous immunoglobulin (IVIg) within 4 weeks prior to first treatment.
- Use of plasma exchange or immunoadsorption within 4 weeks prior to first treatment.
- Prior use of complement inhibitors (e.g., eculizumab, ravulizumab, crovalimab, or other complement inhibitors).
- Use of telitacicept or other B-cell stimulating factor inhibitors within 3 months or 5 half-lives prior to screening (whichever is longer); use of rituximab, ocrelizumab, or other B-cell depletion therapies within 6 months prior to screening.
- Use of human neonatal Fc receptor (FcRn) inhibitors within a period less than 5 half-lives prior to the first dose of study drug.
- History of suicide attempt within the past 12 months, or suicidal ideation or behavior at screening, as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS).
- Participation in any other investigational drug study or exposure to other investigational drugs, devices, or procedures within 30 days prior to screening (investational drugs for complement inhibitors, B-cell depletion therapies, and FcRn inhibitors are governed by exclusion criteria 12, 13, and 14, respectively).
- Suspected allergy to any excipient of the product.
- Any medical condition that, in the opinion of the investigator, may interfere with the participant's participation in the study, pose any additional risk to the participant, or interfere with the assessment of the participant.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Beijing Hospital
Beijing, Beijing Municipality, 100730
Jian Yin, Master, 010-85132266, M13611177824@163.com
Jian Yin, Master
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040
Jianying Xi, Dr., 021-52889999, xijianying@fudan.edu.cn
Jianying Xi, Dr.
About this study
Official title: An Open-label, Dose-escalation Phase Ib Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of Multiple Doses of EA5 Humanized Monoclonal Antibody in Adult Patients With Anti-AChR Antibody-Positive Generalized Myasthenia Gravis
This is a Phase Ib, open-label, dose-escalation, single-center/multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of multiple doses of EA5 (a humanized anti-complement C5 monoclonal antibody) in adult participants with anti-AChR antibody-positive generalized myasthenia gravis (gMG) who have not previously received complement inhibitor therapy. Approximately 18 participants will be enrolled. The study consists of a screening period (Day -42 to Day -1), a loading period (Day 1 to Day 14), a treatment observation period (Day 15/Week 3 to Day 99/Week 15), and an end-of-study visit (up to Day 155/Week 23). All participants receive a loading does , then are assigned to one of three maintenance dose cohorts: Cohort 1 (Low Dose), Cohort 2 (MID Dose), and Cohort 3 (High Dose). The primary objective is to assess safety and tolerability. Secondary objectives include preliminary efficacy, PK, PD (complement inhibition), and immunogenicity.
- Conditions
- Generalized Myasthenia Gravis (gMG)
- Being tested
- EA5
- Keywords
- EA5, Generalized Myasthenia Gravis, Complement C5 Inhibitor, Phase Ib, Anti-AChR
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EA5Drug
First, administer the loading dose regimen intravenously, then maintain administration subcutaneously every 2 weeks(Q2W).
EA5Drug
First, administer the loading dose regimen intravenously, then maintain administration subcutaneously every 2 weeks(Q2W).
EA5Drug
First, administer the loading dose regimen intravenously, then maintain administration subcutaneously every 4 weeks(Q4W).
| Study group | Role | What they receive |
|---|---|---|
| Administration of low-dose EA5 | Experimental | First, administer the loading dose regimen intravenously, then maintain administration subcutaneously every 2 weeks(Q2W). Receives: Drug: EA5 |
| Administration of mid-dose EA5 | Experimental | First, administer the loading dose regimen intravenously, then maintain administration subcutaneously every 2 weeks(Q2W). Receives: Drug: EA5 |
| Administration of high-dose EA5 | Experimental | First, administer the loading dose regimen intravenously, then maintain administration subcutaneously every 4 weeks(Q4W). Receives: Drug: EA5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Treatment Emergent Adverse Events (TEAEs)
Measured: Baseline up to Week 14
Secondary outcomes (23)
Change and percentage change from baseline in MG-ADL total score.
The proportion of participants who achieve the Myasthenia Gravis Activities of Daily Living Profile (MG-ADL) response , along with the 2-sided 95% CI
Measured: Weeks 2, 4, 8, and 12
Change and percentage change from baseline in QMG total score.
The mean change of quantitative myasthenia gravis (QMG) total score，along with 2-sided 95% CI
Measured: Weeks 2, 4, 8, and 12
Change and percentage change from baseline in MGC total score.
The mean change of myasthenia gravis composite (MGC) total score, along with 2-sided 95% CI
Measured: Weeks 2, 4, 8, and 12
Change and percentage change from baseline in MG-QoL15r scale.
The mean change of revised Myasthenia Gravis Quality of Life 15-Item Scale (MG-QoL 15r scale), along with 2-sided 95% CI
Measured: Weeks 2, 4, 8, and 12]
Proportion of participants achieving MG-ADL response without rescue therapy.
MG-ADL response defined as a decrease of ≥3 points after treatment.
Measured: Weeks 2, 4, 8, and 12
Proportion of participants achieving an improvement of 4, 5, 6, 7, and ≥8 points from baseline in QMG total score without rescue therapy.
Measured: Weeks 2, 4, 8, and 12
Maximum Observed Serum Concentration (Cmax) of EA5
Measured: Baseline up to Week 23
Area Under The Serum Concentration Versus Time Curve From Time Zero To The Time of The Last Quantifiable Concentration (AUC0-t) of EA5
Measured: Baseline up to Week 23
Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC0-∞) of EA5
Measured: Baseline up to Week 23
Minimum Steady-State Concentration (Cmin,ss) of EA5
Measured: Baseline up to Week 23
Maximum Steady-State Concentration (Cmax,ss) of EA5
Measured: Baseline up to Week 23
Average Steady-State Concentration (Cav.ss) of EA5
Measured: Baseline up to Week 23
Steady-State Trough Concentration (Ctrough,ss) of EA5
Measured: Baseline up to Week 23
Time to Maximum Steady-State Concentration (Tmax,ss) of EA5
Measured: Baseline up to Week 23
Area Under the Concentration-Time Curve over One Dosing Interval at Steady State (AUC0-τ) of EA5
Measured: Baseline up to Week 23
Degree of Fluctuation of EA5
Measured: Baseline up to Week 23
Serum total complement hemolytic activity (CH50
Measured: Baseline up to Week 23
Serum total C5 concentration
Measured: Baseline up to Week 23
Serum free C5 concentration
Measured: Baseline up to Week 23
Concentrations of plasma soluble C5b-9 (sC5b-9)
Concentration of plasma soluble Complement 5b-9 (sC5b-9)
Measured: Baseline up to Week 23
Anti-acetylcholine receptor antibody (AChR-Ab) titer
Measured: Baseline up to Week 23
Incidence of anti-drug antibodies (ADA) against the humanized monoclonal antibody EA5
Measured: Baseline up to Week 23
Incidence of Incidence of neutralizing antibodies (NAb) against the humanized monoclonal antibody EA5
Measured: Baseline up to Week 23
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start15 Sep 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Myasthenia Gravis (gMG)Studies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Lanyi Therapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07818291
- Sponsor's protocol ID
- C-EA5-2502
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Dose-escalation Phase Ib Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of Multiple Doses of EA5 Humanized Monoclonal Antibody in Adult Patients With Anti-AChR Antibody-Positive Generalized Myasthenia Gravis
- ClinicalTrials.gov ID
- NCT07818291
- Acronym / sponsor ID
- C-EA5-2502
- Conditions
- Generalized Myasthenia Gravis (gMG)
- Keywords
- EA5, Generalized Myasthenia Gravis, Complement C5 Inhibitor, Phase Ib, Anti-AChR
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Shanghai Lanyi Therapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 14 Sep 2026 (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.
This is a Phase Ib, open-label, dose-escalation, single-center/multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of multiple doses of EA5 (a humanized anti-complement C5 monoclonal antibody) in adult participants with anti-AChR antibody-positive generalized myasthenia gravis (gMG) who have not previously received complement inhibitor therapy. Approximately 18 participants will be enrolled. The study consists of a screening period (Day -42 to Day -1), a loading period (Day 1 to Day 14), a treatment observation period (Day 15/Week 3 to Day 99/Week 15), and an end-of-study visit (up to Day 155/Week 23). All participants receive a loading does , then are assigned to one of three maintenance dose cohorts: Cohort 1 (Low Dose), Cohort 2 (MID Dose), and Cohort 3 (High Dose). The primary objective is to assess safety and tolerability. Secondary objectives include preliminary efficacy, PK, PD (complement inhibition), and immunogenicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Administration of low-dose EA5 | Experimental | Drug: EA5First, administer the loading dose regimen intravenously, then maintain administration subcutaneously every 2 weeks(Q2W). |
| Administration of mid-dose EA5 | Experimental | Drug: EA5First, administer the loading dose regimen intravenously, then maintain administration subcutaneously every 2 weeks(Q2W). |
| Administration of high-dose EA5 | Experimental | Drug: EA5First, administer the loading dose regimen intravenously, then maintain administration subcutaneously every 4 weeks(Q4W). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Male or female aged ≥18 years.
- Diagnosis of myasthenia gravis (MG) confirmed by:
- Body weight between 40 kg and 100 kg (inclusive) at screening.
- MGFA clinical classification Class II to IVa at screening.
- MG-ADL total score ≥5 at screening, with more than 50% of the total score from non-ocular symptoms.
Key exclusion criteria (29 listed)
- Presence of untreated thymic epithelial tumors (including all types of thymoma or thymic carcinoma), extrathymic germ cell tumor, or other malignant mediastinal masses at the screening visit; or, as judged by the investigator, presence of thymic cysts or other space-occupying lesions requiring immediate intervention.
- History of thymectomy or any other thymic surgery within 12 months prior to screening, or planned thymectomy during the trial period.
- Prior history of thymic tumor is permitted for enrollment only if the subject meets all criteria in either of the following risk groups:
- Low recurrence risk group: Subjects with histopathologically confirmed thymoma of Masaoka-Koga stages I-II (WHO types A, AB, B1, or B2) who meet all of the following criteria are eligible for enrollment in this study:
- Curative treatment (e.g., R0 surgical resection) completed ≥ 12 months prior to the screening visit;
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 |
|---|---|---|
| EA5First, administer the loading dose regimen intravenously, then maintain administration subcutaneously every 2 weeks(Q2W). | Drug | Administration of low-dose EA5 |
| EA5First, administer the loading dose regimen intravenously, then maintain administration subcutaneously every 2 weeks(Q2W). | Drug | Administration of mid-dose EA5 |
| EA5First, administer the loading dose regimen intravenously, then maintain administration subcutaneously every 4 weeks(Q4W). | Drug | Administration of high-dose EA5 |
Primary outcome
Incidence and Severity of Treatment Emergent Adverse Events (TEAEs)
Time frame: Baseline up to Week 14
23 secondary outcomes
Change and percentage change from baseline in MG-ADL total score.
Time frame: Weeks 2, 4, 8, and 12
Change and percentage change from baseline in QMG total score.
Time frame: Weeks 2, 4, 8, and 12
Change and percentage change from baseline in MGC total score.
Time frame: Weeks 2, 4, 8, and 12
Change and percentage change from baseline in MG-QoL15r scale.
Time frame: Weeks 2, 4, 8, and 12]
Proportion of participants achieving MG-ADL response without rescue therapy.
Time frame: Weeks 2, 4, 8, and 12
Proportion of participants achieving an improvement of 4, 5, 6, 7, and ≥8 points from baseline in QMG total score without rescue therapy.
Time frame: Weeks 2, 4, 8, and 12
Maximum Observed Serum Concentration (Cmax) of EA5
Time frame: Baseline up to Week 23
Area Under The Serum Concentration Versus Time Curve From Time Zero To The Time of The Last Quantifiable Concentration (AUC0-t) of EA5
Time frame: Baseline up to Week 23
Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC0-∞) of EA5
Time frame: Baseline up to Week 23
Minimum Steady-State Concentration (Cmin,ss) of EA5
Time frame: Baseline up to Week 23
Maximum Steady-State Concentration (Cmax,ss) of EA5
Time frame: Baseline up to Week 23
Average Steady-State Concentration (Cav.ss) of EA5
Time frame: Baseline up to Week 23
Steady-State Trough Concentration (Ctrough,ss) of EA5
Time frame: Baseline up to Week 23
Time to Maximum Steady-State Concentration (Tmax,ss) of EA5
Time frame: Baseline up to Week 23
Area Under the Concentration-Time Curve over One Dosing Interval at Steady State (AUC0-τ) of EA5
Time frame: Baseline up to Week 23
Degree of Fluctuation of EA5
Time frame: Baseline up to Week 23
Serum total complement hemolytic activity (CH50
Time frame: Baseline up to Week 23
Serum total C5 concentration
Time frame: Baseline up to Week 23
Serum free C5 concentration
Time frame: Baseline up to Week 23
Concentrations of plasma soluble C5b-9 (sC5b-9)
Time frame: Baseline up to Week 23
Anti-acetylcholine receptor antibody (AChR-Ab) titer
Time frame: Baseline up to Week 23
Incidence of anti-drug antibodies (ADA) against the humanized monoclonal antibody EA5
Time frame: Baseline up to Week 23
Incidence of Incidence of neutralizing antibodies (NAb) against the humanized monoclonal antibody EA5
Time frame: Baseline up to Week 23
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EA5 in people with Generalized Myasthenia Gravis (gMG), run by Shanghai Lanyi Therapeutics Co., Ltd. at 2 sites 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 17 inclusion and 29 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: opening soon, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianying Xi, Doctor (021-52889999, xijianying@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Severity of Treatment Emergent Adverse Events (TEAEs) (time frame: Baseline up to Week 14). 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 14 Sep 2026.