Rheumatoid Arthritis (RA)Phase 1NCT07182656
Safety, Tolerability, and PK/PD of CIGB-814 in Chinese Health Participants
A Phase 1 study testing CIGB-814 (single-dose group) and CIGB-814 (multiple-dose group) in people with Rheumatoid Arthritis (RA), run by Yi Fang at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of CIGB-814 for injection after single and multiple administrations in healthy participants. Secondary objectives include the assessment of preliminary pharmacodynamics (PD) and immunogenicity. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- What is being tested?
- CIGB-814 (single-dose group) and CIGB-814 (multiple-dose group)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 18 Aug 2025to 30 Apr 2026
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must meet all of the following criteria to be eligible for the study:
- Healthy male or female participants aged 18 to 45 years, inclusive.
- Male participants weighing at least 50.0 kg, and female participants weighing at least 45.0 kg, with a body mass index (BMI) between 19.0 and 26.0 kg/m², inclusive (BMI = weight [kg] / height² [m²]).
- Able to communicate effectively with the investigators, understand and comply with all study requirements, and willing to adhere strictly to the study procedures and follow-up schedule. Participants must provide written informed consent prior to any study-related procedures.
- From the date of signing the informed consent until 6 months after study completion, participants must not have plans for conception. Female participants must not have plans to donate oocytes and agree to use reliable contraception to avoid pregnancy. Male participants must not have plans to donate sperm and agree to use reliable contraception to prevent pregnancy of their partner.
Who cannot join
- Participants meeting any of the following criteria will be excluded from the study:
- 1.History or presence of any clinically significant disease, including but not limited to:
- Respiratory (e.g., past or active tuberculosis), cardiovascular, gastrointestinal, urinary, musculoskeletal, endocrine (e.g., adrenal insufficiency), neurological or psychiatric (e.g., epilepsy), hematologic (particularly any hemolytic disorders such as glucose-6-phosphate dehydrogenase [G6PD] deficiency or paroxysmal nocturnal hemoglobinuria [PNH]), immune system disorders, or known significant bleeding tendencies;
- Fever or infectious disease within 3 days prior to screening;
- History of gastrointestinal, liver, or kidney diseases, including prior partial resection of these organs;
- Severe infection, trauma, or surgery within 12 weeks prior to screening, or planned surgery during the study deemed unsuitable by the investigator;
Show all 26Show fewer
- Clinically significant acute illness (e.g., gastrointestinal disorders, infections) within 4 weeks prior to screening;
- Chronic pain (persistent or recurrent for >3 months) or currently experiencing acute pain (<3 months).
- 2.History of significant allergies, including known hypersensitivity to any investigational product or its components, food allergies, pollen allergies, or other allergic conditions.
- 3.Smoking more than 5 cigarettes per day (or equivalent tobacco use) within 3 months prior to screening, or inability to abstain from tobacco during the study.
- 4.History of alcohol abuse, average alcohol consumption ≥14 units/week within 3 months prior to screening (1 unit = 10 mL ethanol, e.g., 200 mL beer [5%], 25 mL spirits [40%], or 83 mL wine [12%]), positive alcohol breath test at admission, or inability to abstain from alcohol during the study.
- 5.Excessive consumption of tea, coffee, or other caffeinated beverages (average >8 cups/day, 1 cup = 250 mL) within 3 months prior to screening.
- 6.Inability to refrain from caffeine-containing foods or beverages (e.g., coffee, strong tea, cola, chocolate) within 72 hours prior to admission or during the study, or consumption of other foods affecting drug absorption, distribution, metabolism, or excretion (e.g., dragon fruit, mango, grapefruit, pomelo, orange, starfruit, guava).
- 7.Participation in another clinical trial involving drugs or devices within 3 months prior to screening, or use of investigational products prior to first admission.
- 8.Vaccination (including but not limited to COVID-19, tetanus, rabies, HPV) within 2 months prior to screening.
- 9.Blood donation or significant blood loss (≥400 mL) within 3 months prior to screening, transfusion or use of blood products within 3 months prior, blood loss ≥200 mL within 30 days, or plasma/aphresis donation within 7 days prior.
- 10.Use of prescription drugs, over-the-counter drugs, herbal medicines, or dietary supplements within 14 days prior to screening or between screening and first admission.
- 11.History of syncope related to needles or blood, difficulty with blood collection, or orthostatic hypotension.
- 12.Special dietary requirements preventing adherence to a standardized diet.
- 13.History of substance abuse or drug addiction, or positive test for addictive substances (methamphetamine, MDMA, THC, morphine, ketamine) on the day of admission.
- 14.Pregnant or breastfeeding women, or women of childbearing potential with a positive pregnancy test.
- 15.Abnormal vital signs, physical examination, laboratory tests, ECG, CT, or ultrasound deemed clinically significant by the investigator.
- 16.Women using oral contraceptives within 30 days prior to screening or during the study, or long-acting estrogen/progestin injections or implants within 6 months prior to screening or during the study.
- 17.Positive test for hepatitis B surface antigen, hepatitis C antibody, HIV antibody, or syphilis (Treponema pallidum) antibody.
- 18.Any other condition or factor deemed by the investigator to make the participant unsuitable for the study.
- Chronic pain is defined as persistent or recurrent pain lasting more than 3 months. Acute pain is defined as pain lasting less than 3 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 101149
Yi Fang, MD, 010-66583834, fygk7000@163.com
About this study
Official title: A Phase I Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Pharmacodynamics of Single and Multiple Doses of CIGB-814 in Healthy Participants
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of CIGB-814 for injection after single and multiple administrations in healthy participants. Secondary objectives include the assessment of preliminary pharmacodynamics (PD) and immunogenicity. Exploratory objectives are to investigate changes in immune cell subsets and signaling pathways following multiple administrations of CIGB-814.
- Conditions
- Rheumatoid Arthritis (RA)
- Being tested
- CIGB-814 (single-dose group), CIGB-814 placebo (single-dose group), CIGB-814 (multiple-dose group), CIGB-814 placebo (multiple-dose group)
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CIGB-814 (single-dose group)Drug
CIGB-814, single ascending dose, SC injection
CIGB-814 placebo (single-dose group)Drug
CIGB-814 placebo, single ascending dose, SC injection
CIGB-814 (multiple-dose group)Drug
CIGB-814, multiple ascending dose, SC injection
CIGB-814 placebo (multiple-dose group)Drug
CIGB-814 placebo, multiple ascending dose, SC injection
| Study group | Role | What they receive |
|---|---|---|
| CIGB-814 (single-dose group) | Experimental | Not described Receives: Drug: CIGB-814 (single-dose group) |
| CIGB-814 placebo (single-dose group) | Placebo comparator | Not described Receives: Drug: CIGB-814 placebo (single-dose group) |
| CIGB-814 (multiple-dose group) | Experimental | Not described Receives: Drug: CIGB-814 (multiple-dose group) |
| CIGB-814 placebo (multiple-dose group) | Placebo comparator | Not described Receives: Drug: CIGB-814 placebo (multiple-dose group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Cmax after single-dose administration and Cmax after the first dose in the multiple-dose group
Measured: Within 60 minutes prior to dosing, and at 5, 15, 30, and 45 minutes, and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, and 12 hours post-dose.
Tmax
Tmax after single-dose administration and Tmax after the first dose in the multiple-dose group
Measured: Within 60 minutes prior to dosing, and at 5, 15, 30, and 45 minutes, and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, and 12 hours post-dose.
AUC0-t
AUC0-t after single-dose administration and AUC0-t after the first dose in the multiple-dose group
Measured: Within 60 minutes prior to dosing, and at 5, 15, 30, and 45 minutes, and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, and 12 hours post-dose.
AUC0-∞
AUC0-∞ after single-dose administration and AUC0-∞ after the first dose in the multiple-dose group
Measured: Within 60 minutes prior to dosing, and at 5, 15, 30, and 45 minutes, and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, and 12 hours post-dose.
Secondary outcomes (20)
t1/2
t1/2 after single-dose administration and t1/2 after the first dose in the multiple-dose group
Measured: Within 60 minutes prior to dosing, and at 5, 15, 30, and 45 minutes, and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, and 12 hours post-dose.
λz
λz after single-dose administration and λz after the first dose in the multiple-dose group
Measured: Within 60 minutes prior to dosing, and at 5, 15, 30, and 45 minutes, and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, and 12 hours post-dose.
AUC_%Extrap
AUC_%Extrap after single-dose administration and AUC_%Extrap after the first dose in the multiple-dose group
Measured: Within 60 minutes prior to dosing, and at 5, 15, 30, and 45 minutes, and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, and 12 hours post-dose.
Css_min
Trough concentration at steady state (Css_min) in the multiple-dose group
Measured: Within 60 minutes prior to dosing, and at 5, 15, 30, and 45 minutes, and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, and 12 hours post-dose.
Css_max
Peak concentration at steady state (Css_max) in the multiple-dose group
Measured: Within 60 minutes prior to dosing, and at 5, 15, 30, and 45 minutes, and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, and 12 hours post-dose.
TNF-α
Tumor Necrosis Factor-α
Measured: single-dose group: baseline and at Day 8 and Day 15 post-dose; multiple-dose group: baseline and at Day 35 and Day 49 post-dose.
IFN-γ
Interferon-γ
Measured: single-dose group: baseline and at Day 8 and Day 15 post-dose; multiple-dose group: baseline and at Day 35 and Day 49 post-dose.
IL-6
Interleukin-6
Measured: single-dose group: baseline and at Day 8 and Day 15 post-dose; multiple-dose group: baseline and at Day 35 and Day 49 post-dose.
IL-10
Interleukin-10
Measured: single-dose group: baseline and at Day 8 and Day 15 post-dose; multiple-dose group: baseline and at Day 35 and Day 49 post-dose.
IL-17A
Interleukin-17A
Measured: single-dose group: baseline and at Day 8 and Day 15 post-dose; multiple-dose group: baseline and at Day 35 and Day 49 post-dose.
CD3+ T cell
CD3+ T cell subsets
Measured: single-dose group: baseline and at Day 8 and Day 15 post-dose; multiple-dose group: baseline and at Day 35 and Day 49 post-dose.
CD4+ T cell
CD4+ T cell subsets
Measured: single-dose group: baseline and at Day 8 and Day 15 post-dose; multiple-dose group: baseline and at Day 35 and Day 49 post-dose.
CD8+ T cell
CD8+ T cell subsets
Measured: single-dose group: baseline and at Day 8 and Day 15 post-dose; multiple-dose group: baseline and at Day 35 and Day 49 post-dose.
ANA
Antinuclear Antibody
Measured: single-dose group: baseline and at Day 8 and Day 15 post-dose; multiple-dose group: baseline and at Day 35 and Day 49 post-dose.
ESR
Erythrocyte Sedimentation Rate
Measured: single-dose group: baseline and at Day 8 and Day 15 post-dose; multiple-dose group: baseline and at Day 35 and Day 49 post-dose.
CRP
C-Reactive Protein
Measured: single-dose group: baseline and at Day 8 and Day 15 post-dose; multiple-dose group: baseline and at Day 35 and Day 49 post-dose.
Ig E
Immunoglobulin E
Measured: single-dose group: baseline and at Day 8 and Day 15 post-dose; multiple-dose group: baseline and at Day 35 and Day 49 post-dose.
Ig G
Immunoglobulin G
Measured: single-dose group: baseline and at Day 8 and Day 15 post-dose; multiple-dose group: baseline and at Day 35 and Day 49 post-dose.
Ig M
Immunoglobulin M
Measured: single-dose group: baseline and at Day 8 and Day 15 post-dose; multiple-dose group: baseline and at Day 35 and Day 49 post-dose.
Ig A
Immunoglobulin A
Measured: single-dose group: baseline and at Day 8 and Day 15 post-dose; multiple-dose group: baseline and at Day 35 and Day 49 post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start18 Aug 2025
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yi Fang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yi Fang, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07182656
- Sponsor's protocol ID
- SDLK-20250425PK-CIGB814
- Status last verified
- Sep 2025
- First submitted
- 26 Aug 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Pharmacodynamics of Single and Multiple Doses of CIGB-814 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07182656
- Acronym / sponsor ID
- SDLK-20250425PK-CIGB814
- Conditions
- Rheumatoid Arthritis (RA)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Yi FangUniversity, hospital or other
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 19 Sep 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.
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of CIGB-814 for injection after single and multiple administrations in healthy participants. Secondary objectives include the assessment of preliminary pharmacodynamics (PD) and immunogenicity. Exploratory objectives are to investigate changes in immune cell subsets and signaling pathways following multiple administrations of CIGB-814.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CIGB-814 (single-dose group) | Experimental | Drug: CIGB-814 (single-dose group) |
| CIGB-814 placebo (single-dose group) | Placebo comparator | Drug: CIGB-814 placebo (single-dose group) |
| CIGB-814 (multiple-dose group) | Experimental | Drug: CIGB-814 (multiple-dose group) |
| CIGB-814 placebo (multiple-dose group) | Placebo comparator | Drug: CIGB-814 placebo (multiple-dose group) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participants must meet all of the following criteria to be eligible for the study:
Key exclusion criteria (26 listed)
- Participants meeting any of the following criteria will be excluded from the study:
- 1.History or presence of any clinically significant disease, including but not limited to:
- 2.History of significant allergies, including known hypersensitivity to any investigational product or its components, food allergies, pollen allergies, or other allergic conditions.
- 3.Smoking more than 5 cigarettes per day (or equivalent tobacco use) within 3 months prior to screening, or inability to abstain from tobacco during the study.
- 4.History of alcohol abuse, average alcohol consumption ≥14 units/week within 3 months prior to screening (1 unit = 10 mL ethanol, e.g., 200 mL beer [5%], 25 mL spirits [40%], or 83 mL wine [12%]), positive alcohol breath test at admission, or inability to abstain from alcohol during the study.
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 |
|---|---|---|
| CIGB-814 (single-dose group)CIGB-814, single ascending dose, SC injection | Drug | CIGB-814 (single-dose group) |
| CIGB-814 placebo (single-dose group)CIGB-814 placebo, single ascending dose, SC injection | Drug | CIGB-814 placebo (single-dose group) |
| CIGB-814 (multiple-dose group)CIGB-814, multiple ascending dose, SC injection | Drug | CIGB-814 (multiple-dose group) |
| CIGB-814 placebo (multiple-dose group)CIGB-814 placebo, multiple ascending dose, SC injection | Drug | CIGB-814 placebo (multiple-dose group) |
Primary outcome
Cmax
Time frame: Within 60 minutes prior to dosing, and at 5, 15, 30, and 45 minutes, and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, and 12 hours post-dose.
Cmax after single-dose administration and Cmax after the first dose in the multiple-dose group
Tmax
Time frame: Within 60 minutes prior to dosing, and at 5, 15, 30, and 45 minutes, and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, and 12 hours post-dose.
Tmax after single-dose administration and Tmax after the first dose in the multiple-dose group
AUC0-t
Time frame: Within 60 minutes prior to dosing, and at 5, 15, 30, and 45 minutes, and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, and 12 hours post-dose.
AUC0-t after single-dose administration and AUC0-t after the first dose in the multiple-dose group
AUC0-∞
Time frame: Within 60 minutes prior to dosing, and at 5, 15, 30, and 45 minutes, and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, and 12 hours post-dose.
AUC0-∞ after single-dose administration and AUC0-∞ after the first dose in the multiple-dose group
20 secondary outcomes
t1/2
Time frame: Within 60 minutes prior to dosing, and at 5, 15, 30, and 45 minutes, and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, and 12 hours post-dose.
λz
Time frame: Within 60 minutes prior to dosing, and at 5, 15, 30, and 45 minutes, and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, and 12 hours post-dose.
AUC_%Extrap
Time frame: Within 60 minutes prior to dosing, and at 5, 15, 30, and 45 minutes, and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, and 12 hours post-dose.
Css_min
Time frame: Within 60 minutes prior to dosing, and at 5, 15, 30, and 45 minutes, and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, and 12 hours post-dose.
Css_max
Time frame: Within 60 minutes prior to dosing, and at 5, 15, 30, and 45 minutes, and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, and 12 hours post-dose.
TNF-α
Time frame: single-dose group: baseline and at Day 8 and Day 15 post-dose; multiple-dose group: baseline and at Day 35 and Day 49 post-dose.
IFN-γ
Time frame: single-dose group: baseline and at Day 8 and Day 15 post-dose; multiple-dose group: baseline and at Day 35 and Day 49 post-dose.
IL-6
Time frame: single-dose group: baseline and at Day 8 and Day 15 post-dose; multiple-dose group: baseline and at Day 35 and Day 49 post-dose.
IL-10
Time frame: single-dose group: baseline and at Day 8 and Day 15 post-dose; multiple-dose group: baseline and at Day 35 and Day 49 post-dose.
IL-17A
Time frame: single-dose group: baseline and at Day 8 and Day 15 post-dose; multiple-dose group: baseline and at Day 35 and Day 49 post-dose.
CD3+ T cell
Time frame: single-dose group: baseline and at Day 8 and Day 15 post-dose; multiple-dose group: baseline and at Day 35 and Day 49 post-dose.
CD4+ T cell
Time frame: single-dose group: baseline and at Day 8 and Day 15 post-dose; multiple-dose group: baseline and at Day 35 and Day 49 post-dose.
CD8+ T cell
Time frame: single-dose group: baseline and at Day 8 and Day 15 post-dose; multiple-dose group: baseline and at Day 35 and Day 49 post-dose.
ANA
Time frame: single-dose group: baseline and at Day 8 and Day 15 post-dose; multiple-dose group: baseline and at Day 35 and Day 49 post-dose.
ESR
Time frame: single-dose group: baseline and at Day 8 and Day 15 post-dose; multiple-dose group: baseline and at Day 35 and Day 49 post-dose.
CRP
Time frame: single-dose group: baseline and at Day 8 and Day 15 post-dose; multiple-dose group: baseline and at Day 35 and Day 49 post-dose.
Ig E
Time frame: single-dose group: baseline and at Day 8 and Day 15 post-dose; multiple-dose group: baseline and at Day 35 and Day 49 post-dose.
Ig G
Time frame: single-dose group: baseline and at Day 8 and Day 15 post-dose; multiple-dose group: baseline and at Day 35 and Day 49 post-dose.
Ig M
Time frame: single-dose group: baseline and at Day 8 and Day 15 post-dose; multiple-dose group: baseline and at Day 35 and Day 49 post-dose.
Ig A
Time frame: single-dose group: baseline and at Day 8 and Day 15 post-dose; multiple-dose group: baseline and at Day 35 and Day 49 post-dose.
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 19 Sep 2025.
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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.
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 CIGB-814 (single-dose group) and CIGB-814 (multiple-dose group) in people with Rheumatoid Arthritis (RA), run by Yi Fang 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 26 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: looking for participants now, as of the sponsor's last update on 19 Sep 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?
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 Yi Fang, MD (010-66583834, fygk7000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: Within 60 minutes prior to dosing, and at 5, 15, 30, and 45 minutes, and at 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, and 12 hours post-dose.). The study lists 4 primary outcomes in all. 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 19 Sep 2025.