Healthy VolunteersPhase 1NCT07256288
A Phase Ia Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of EA5 in Healthy Adult Subjects
A Phase 1 study testing EA5 in people with Healthy Volunteers, run by Shanghai Lanyi Therapeutics Co., Ltd. at 1 site in China.
Trial summary
This is a single-center, double-blind, placebo-controlled, dose-escalating Phase Ia clinical study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of a single dose of EA5 in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- EA5
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 31 May 2023to 1 Aug 2024
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects aged 18 to 55 years (inclusive), regardless of gender.
- Body weight ≥50 kg (male) or ≥45 kg (female), and a body mass index (BMI) between 18 and 28 kg/m² (inclusive).
- Must have received the meningococcal polysaccharide vaccine MenACWY (containing serogroups A, C, W, and Y) at least two weeks prior to dosing.
- Subjects must be able to communicate effectively with the investigator and are expected to comply with the study procedures as defined in the protocol.
- Subjects must be in good general health, as judged by the investigator based on medical history, physical examination, vital signs, electrocardiogram (ECG), chest X-ray, abdominal ultrasound, and laboratory test results.
- Male subjects agree to use effective contraception (vasectomy, abstinence, or condom) from screening until 6 months after the final study intervention. Female subjects must have a negative blood pregnancy test at screening and baseline. Throughout the study and for 6 months thereafter, all subjects and their partners (if of childbearing potential) must use highly effective non-pharmacological contraception.
- Subjects must provide written informed consent voluntarily before any study-specific procedures are performed.
- Systolic and diastolic blood pressure must be within the normal range, or exhibit abnormalities deemed clinically insignificant by the investigator.
Who cannot join
- History of severe drug allergy; or a clear history of allergy and/or known allergy to the investigational product or any of its excipients, which in the opinion of the investigator, renders the subject unsuitable for participation in the study.
- Prior history of splenectomy.
- History of pulmonary tuberculosis.
- Congenital or acquired complement deficiency (e.g., hypocomplementemia).
- Any contraindication to antibiotic prophylaxis (e.g., beta-lactam antibiotics, ciprofloxacin) for meningococcal infection
- Positive test for hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, treponemal antibody (TP-Ab), or hepatitis B virus (HBV) surface antigen (HBsAg) at screening
Show all 19Show fewer
- Presence of symptoms or a significant history of any major disease, including but not limited to cardiac, hepatic, renal, other acute or chronic gastrointestinal or respiratory diseases; hematological, endocrine, neurological, psychiatric disorders; or any other disease or physiological condition that could interfere with the interpretation of the study results.
- Participation in any clinical trial involving an investigational drug or medical device within 3 months prior to screening, or within 5 half-lives of the previous investigational drug prior to screening (whichever is longer)
- Blood loss or donation > 400 mL within 3 months prior to screening, or > 200 mL within 4 weeks prior to screening, or intention to donate blood during the study period
- Average cigarette smoking of ≥5 cigarettes per day within 3 months prior to the study
- Alcohol abuse or regular alcohol consumption exceeding 14 units per week within 6 months prior to screening (1 unit ≈ 360 mL beer, 45 mL 40% spirits, or 150 mL wine), or a positive alcohol breath test at screening.
- History of drug abuse or a positive urine drug screen at screening
- Undergone surgery or received blood or blood product transfusion within 1 month prior to screening。
- Administration of any live or live-attenuated vaccine within 1 month prior to the first dose。
- Use of any prescription drugs, over-the-counter medications, herbal medicines, or vitamins within 14 days or 5 half-lives (whichever is longer) prior to screening。
- Presence of any active infection (viral, bacterial, or fungal), including herpes zoster or herpes simplex, within 14 days prior to dosing.
- History of fever (≥38°C) within 7 days prior to the first dose.
- Female subjects who are pregnant or lactating, or who have engaged in unprotected sexual intercourse within 14 days prior to the study.
- Inability to complete the study for any other reason, or considered by the investigator to be unsuitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230601
About this study
Official title: A Single-Center, Double-Blind, Placebo-Controlled, Dose-Escalating Phase Ia Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Characteristics of EA5 in a Single Dose in Adult Healthy Subjects
This is a single-center, double-blind, placebo-controlled, dose-escalating Phase Ia clinical study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of a single dose of EA5 in healthy adult subjects.
Read the detailed description
The study plans to enroll up to 28 subjects. Its primary purpose is to conduct a preliminary assessment of the exposure, safety, and pharmacokinetic profile of EA5 in humans, thereby informing the confirmation or adjustment of the formal trial design. The trial is structured into a pilot phase and a formal phase, encompassing a total of five planned dose cohorts: the pilot trial involves two dose groups (90 mg and 180 mg), each with 2 subjects receiving the active drug; the formal trial consists of three dose groups (360 mg, 720 mg, and 1440 mg), where participants are randomized in a 3:1 ratio (6 subjects receiving the active drug EA5 and 2 subjects receiving placebo per cohort), administered via intravenous (IV) infusion.A 57-day observation period was performed for safety, pharmacokinetic, and pharmacodynamic assessments after study drug administration. Antidrug antibody (ADA) levels were monitored in study participants for the duration of the 57-day follow-up period.
- Conditions
- Healthy Volunteers
- Being tested
- EA5, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EA5Drug
All doses of EA5 were administered by IV infusion, using programmable IV infusion pump and IV sets with in-line filters.
PlaceboDrug
All doses of placebo were administered by IV infusion, using programmable IV infusion pump and IV sets with in-line filters.
| Study group | Role | What they receive |
|---|---|---|
| EA5 90mg | Experimental | EA5 was administered intravenously. Receives: Drug: EA5 |
| EA5 180mg | Experimental | EA5 was administered intravenously. Receives: Drug: EA5 |
| EA5 360mg | Experimental | EA5 was administered intravenously. Receives: Drug: EA5; Drug: Placebo |
| EA5 720mg | Experimental | EA5 was administered intravenously. Receives: Drug: EA5; Drug: Placebo |
| EA5 1440mg | Experimental | EA5 was administered intravenously. Receives: Drug: EA5; Drug: Placebo |
| Placebo | Placebo comparator | Placebo was administered intravenously. Receives: Drug: EA5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
TEAEs were defined as AEs that occurred on or after the date and time of study drug administration, or those that first occurred before dosing but worsened in frequency or severity after study drug administration. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Measured: Baseline up to Day 57
Secondary outcomes (11)
Maximum Observed Serum Concentration (Cmax) of EA5
Blood samples were collected for analysis of Cmax
Measured: 30 minutes predose, 5 minutes, 1, 2, 6, 24, hours postdose, then at Days 3, 4, 8, 15, 29, 43, 57
Time To Maximum Observed Serum Concentration (Tmax) of EA5
Blood samples were collected for analysis of Tmax
Measured: 30 minutes predose, 5 minutes, 1, 2, 6, 24, hours postdose, then at Days 3, 4, 8, 15, 29, 43, 57
Area Under The Serum Concentration Versus Time Curve From Time Zero To The Time of The Last Quantifiable Concentration (AUC0-t) of EA5
Blood samples were collected for analysis of AUC0-t
Measured: 30 minutes predose, 5 minutes, 1, 2, 6, 24, hours postdose, then at Days 3, 4, 8, 15, 29, 43, 57
Area Under The Serum Concentration Versus Time Curve From Time Zero (Dosing) To Infinity (AUCinf) of EA5
Blood samples were collected for analysis of AUCinf
Measured: 30 minutes predose, 5 minutes, 1, 2, 6, 24, hours postdose, then at Days 3, 4, 8, 15, 29, 43, 57
Terminal Elimination Rate Constant (λz) of Serum EA5
Blood samples were collected for analysis of λz
Measured: 30 minutes predose, 5 minutes, 1, 2, 6, 24, hours postdose, then at Days 3, 4, 8, 15, 29, 43, 57
Terminal Elimination Half-life (t½) of Serum EA5
Blood samples were collected for analysis of t½
Measured: 30 minutes predose, 5 minutes, 1, 2, 6, 24, hours postdose, then at Days 3, 4, 8, 15, 29, 43, 57
Total Clearance (CL) of EA5
Blood samples were collected for analysis of CL
Measured: 30 minutes predose, 5 minutes, 1, 2, 6, 24, hours postdose, then at Days 3, 4, 8, 15, 29, 43, 57
Percent Change From Baseline in Free Complement Component 5 (C5)
Blood samples were collected for analysis of free C5 concentrations.
Measured: Baseline, Day 57
Percent Change From Baseline in Total Complement C5
Blood samples were collected for analysis of total C5 concentrations.
Measured: Baseline, Day 57
Percent Change From Baseline in determination of terminal complement activity in serum
Blood samples were collected for analysis of determination of terminal complement activity
Measured: Baseline, Day 57
Percentage of Participants With Positive Anti-Drug Antibody (ADA)
lood samples were collected to evaluate antibody response through development of ADAs.
Measured: Baseline up to Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start31 May 2023
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
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
- Sequential
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Lanyi Therapeutics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wei Hu, Professor, Principal investigator, The Second Hospital of Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07256288
- Sponsor's protocol ID
- C-EA5-2301
- Status last verified
- Oct 2025
- First submitted
- 20 Nov 2025
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Double-Blind, Placebo-Controlled, Dose-Escalating Phase Ia Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Characteristics of EA5 in a Single Dose in Adult Healthy Subjects
- ClinicalTrials.gov ID
- NCT07256288
- Acronym / sponsor ID
- C-EA5-2301
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Shanghai Lanyi Therapeutics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 May 2023 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 1 Dec 2025 (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 single-center, double-blind, placebo-controlled, dose-escalating Phase Ia clinical study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of a single dose of EA5 in healthy adult subjects.
Detailed description
The study plans to enroll up to 28 subjects. Its primary purpose is to conduct a preliminary assessment of the exposure, safety, and pharmacokinetic profile of EA5 in humans, thereby informing the confirmation or adjustment of the formal trial design. The trial is structured into a pilot phase and a formal phase, encompassing a total of five planned dose cohorts: the pilot trial involves two dose groups (90 mg and 180 mg), each with 2 subjects receiving the active drug; the formal trial consists of three dose groups (360 mg, 720 mg, and 1440 mg), where participants are randomized in a 3:1 ratio (6 subjects receiving the active drug EA5 and 2 subjects receiving placebo per cohort), administered via intravenous (IV) infusion.A 57-day observation period was performed for safety, pharmacokinetic, and pharmacodynamic assessments after study drug administration. Antidrug antibody (ADA) levels were monitored in study participants for the duration of the 57-day follow-up period.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| EA5 90mg | Experimental | Drug: EA5EA5 was administered intravenously. |
| EA5 180mg | Experimental | Drug: EA5EA5 was administered intravenously. |
| EA5 360mg | Experimental | Drug: EA5, Drug: PlaceboEA5 was administered intravenously. |
| EA5 720mg | Experimental | Drug: EA5, Drug: PlaceboEA5 was administered intravenously. |
| EA5 1440mg | Experimental | Drug: EA5, Drug: PlaceboEA5 was administered intravenously. |
| Placebo | Placebo comparator | Drug: EA5Placebo was administered intravenously. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Healthy subjects aged 18 to 55 years (inclusive), regardless of gender.
- Body weight ≥50 kg (male) or ≥45 kg (female), and a body mass index (BMI) between 18 and 28 kg/m² (inclusive).
- Must have received the meningococcal polysaccharide vaccine MenACWY (containing serogroups A, C, W, and Y) at least two weeks prior to dosing.
- Subjects must be able to communicate effectively with the investigator and are expected to comply with the study procedures as defined in the protocol.
- Subjects must be in good general health, as judged by the investigator based on medical history, physical examination, vital signs, electrocardiogram (ECG), chest X-ray, abdominal ultrasound, and laboratory test results.
Key exclusion criteria (19 listed)
- History of severe drug allergy; or a clear history of allergy and/or known allergy to the investigational product or any of its excipients, which in the opinion of the investigator, renders the subject unsuitable for participation in the study.
- Prior history of splenectomy.
- History of pulmonary tuberculosis.
- Congenital or acquired complement deficiency (e.g., hypocomplementemia).
- Any contraindication to antibiotic prophylaxis (e.g., beta-lactam antibiotics, ciprofloxacin) for meningococcal infection
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 |
|---|---|---|
| EA5All doses of EA5 were administered by IV infusion, using programmable IV infusion pump and IV sets with in-line filters. | Drug | EA5 1440mg, EA5 180mg, EA5 360mg, EA5 720mg, EA5 90mg, Placebo |
| PlaceboAll doses of placebo were administered by IV infusion, using programmable IV infusion pump and IV sets with in-line filters. | Drug | EA5 1440mg, EA5 360mg, EA5 720mg |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Baseline up to Day 57
TEAEs were defined as AEs that occurred on or after the date and time of study drug administration, or those that first occurred before dosing but worsened in frequency or severity after study drug administration. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
11 secondary outcomes
Maximum Observed Serum Concentration (Cmax) of EA5
Time frame: 30 minutes predose, 5 minutes, 1, 2, 6, 24, hours postdose, then at Days 3, 4, 8, 15, 29, 43, 57
Time To Maximum Observed Serum Concentration (Tmax) of EA5
Time frame: 30 minutes predose, 5 minutes, 1, 2, 6, 24, hours postdose, then at Days 3, 4, 8, 15, 29, 43, 57
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: 30 minutes predose, 5 minutes, 1, 2, 6, 24, hours postdose, then at Days 3, 4, 8, 15, 29, 43, 57
Area Under The Serum Concentration Versus Time Curve From Time Zero (Dosing) To Infinity (AUCinf) of EA5
Time frame: 30 minutes predose, 5 minutes, 1, 2, 6, 24, hours postdose, then at Days 3, 4, 8, 15, 29, 43, 57
Terminal Elimination Rate Constant (λz) of Serum EA5
Time frame: 30 minutes predose, 5 minutes, 1, 2, 6, 24, hours postdose, then at Days 3, 4, 8, 15, 29, 43, 57
Terminal Elimination Half-life (t½) of Serum EA5
Time frame: 30 minutes predose, 5 minutes, 1, 2, 6, 24, hours postdose, then at Days 3, 4, 8, 15, 29, 43, 57
Total Clearance (CL) of EA5
Time frame: 30 minutes predose, 5 minutes, 1, 2, 6, 24, hours postdose, then at Days 3, 4, 8, 15, 29, 43, 57
Percent Change From Baseline in Free Complement Component 5 (C5)
Time frame: Baseline, Day 57
Percent Change From Baseline in Total Complement C5
Time frame: Baseline, Day 57
Percent Change From Baseline in determination of terminal complement activity in serum
Time frame: Baseline, Day 57
Percentage of Participants With Positive Anti-Drug Antibody (ADA)
Time frame: Baseline up to Day 57
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- 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.
Wei Hu, Professor principal investigator
The Second Hospital of Anhui Medical University
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 EA5 in people with Healthy Volunteers, run by Shanghai Lanyi Therapeutics 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 8 inclusion and 19 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: finished, as of the sponsor's last update on 1 Dec 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment Emergent Adverse Events (TEAEs) (time frame: Baseline up to Day 57). 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 1 Dec 2025.