ClinicalTrials.gg
Not yet recruitingNCT07933627Updated Nov 12, 2026

Clinical Study of YKYY013 Injection in HBeAg-negative Chronic Hepatitis B Virus-infected Patients Treated With Nucleos(t)Ide Analogues

A Phase 2 interventional study of YKYY013 and YKYY013 Placebo in HBV (Hepatitis B Virus), sponsored by Beijing Youcare Kechuang Pharmaceutical Technology Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by Beijing Youcare Kechuang Pharmaceutical Technology Co., Ltd. (part of Youcare Pharmaceutical Group Co., Ltd.) · Phase 2, Interventional, and Treatment

Updated Nov 12, 2026Newly registeredGo to Updates ↓

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Phase
Phase 2
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 192 studies in Hepatitis B with a site in China — 39 open to participants now, 49 under way, 1 of them phase 3. Hepatitis B · China.

Planned enrollment
70th of 136
120 · median 123
Started
2026
with 9 others
Phase 2
31 of 192
5 open now
Primary completion
2027-03
later than 25 of 48 live
Registered
192nd of 192
by date

Among the 192 studies in Hepatitis B with a site in China, this one is the 70th largest by planned enrollment of the 136 interventional ones that give a count, is one of 10 that started in 2026, is one of 31 in phase 2, reaches primary completion later than 25 of the 48 other live ones, and was the 192nd registered.

Hepatitis B

1,046 studies on the registry are indexed under Hepatitis B; 139 are open to participants now.

Browse Hepatitis B studies →

Open to participants now

39 of the 192 studies in Hepatitis B with a site in China are open now. Recruiting first, the newest first:

34 more — sign in →

All 39 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 80 Hepatitis B studies recruiting now, 40 (50%) set no upper age limit and 35 (44%) stop at 75 or younger; 14 take children under 18; 20 take healthy volunteers.

This study: 18 Years to 65 Years · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 192 studies in Hepatitis B with a site in China, or all of them as a file.
02

Study summary

To evaluate the efficacy of YKYY013 in patients with chronic hepatitis B virus (HBV) infection with negative hepatitis B e antigen (HBeAg) and treated with nucleoside (acid) analogs (NA).

Read the detailed description

1)Evaluate the safety and tolerability of YKYY013 in patients with HBeAg-negative chronic HBV infection treated with NA; 2) Evaluate the pharmacokinetic (PK,with the serum drug concentration of YKYY013) and pharmacodynamic (PD,with reduction in HBsAg) characteristics of YKYY013 in patients with HBeAg-negative chronic HBV infection treated with NA; 3) Evaluate the immunogenicity of YKYY013 in patients with HBeAg-negative chronic HBV infection treated with NA.

03

Conditions studied

  • HBV (Hepatitis B Virus)

Browse trials for

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. (BMI) between 18.0 to 32.0 kg/m\^2 (inclusive) and body weight equal to or over 50 kg for male and 45 kg for female.
  2. Chronic infection , with positive hepatitis B surface antigen (HBsAg) or HBV DNA for at least 6 months, and continuous stable treatment with a single nucleoside (acid) analogue (NA) for ≥ 6 months.

3)HBeAg-negative at screening; 4)100 IU/mL \< HBsAg ≤ 5000 IU/mL at screening; 5)HBV DNA \< 100 IU/mL at screening. 6) Medically approved (e.g., intrauterine device, oral contraceptive, condom) during the trial and for 6 months after the last dose, Participants must not donate sperm or ova during the trial or for 6 months after the last dose.

7) The participants voluntarily participate in the study, and sign the Form (ICF) prior to screening.

Exclusion criteria

Exclusion Criteria:

  1. Severe allergic reactions, non-allergic drug reactions, multiple drug allergies, or known to the drug or its .
  2. Chronic liver disease other than chronic infection (e.g., severe fatty liver, alcoholic, , or inherited metabolic liver disease).
  3. Liver stiffness measurement (LSM) above 9 kPa at screening, or Metavir F3 or higher on within 1 year before screening.
  4. Current or past hepatic decompensation (e.g., esophagogastric variceal bleeding, ascites, hepatic encephalopathy).
  5. Liver cancer history, or imaging (ultrasound, MRI, CT) suggesting liver cancer, or alpha-fetoprotein (AFP) at least 50 ug/L.
  6. Cardiovascular events (e.g., stroke, , myocardial infarction, unstable angina, coronary bypass surgery, percutaneous coronary intervention, heart failure hospitalization) or valvular heart disease. Other chronic diseases considered unsuitable by the investigator (e.g., respiratory, endocrine, immune, renal, hepatic, gastrointestinal, dermatologic, hematologic, neurologic).
  7. Active pathological bleeding (e.g., peptic ulcer, intracranial hemorrhage) or bleeding tendency (e.g., recurrent gingival bleeding); cured disease without active or clinically significant bleeding may be enrolled at investigator discretion.
  8. Severe infection within 1 month, or infection symptoms within 7 days, before screening.
  9. Major illness or major surgery (excluding minor outpatient procedures) within 3 months before screening, or planned grade 3-4 surgery during the trial.
  10. within 5 years, except cured resected in situ carcinoma (e.g., non-melanoma skin cancer).
  11. Clinically significant abnormalities on physical examination, vital signs, 12-lead (ECG), or chest CT at screening.
  12. Uncontrolled blood pressure at screening (systolic at least 160 mmHg or diastolic at least 100 mmHg despite treatment).
  13. Fridericia- interval (QTcF) at least 450 msec (male) or 470 msec (female); if the first ECG exceeds these limits, two more ECGs are done and the mean of three applies.
  14. Significant laboratory abnormalities at screening, including:

    1. (ALT) or aspartate aminotransferase (AST) at least 2 times the (ULN).
    2. Total at least 2 times ULN with direct bilirubin above ULN.
    3. Serum albumin below 35 g/L.
    4. below 100 x 10\^9/L.
    5. (PT) prolonged by more than 3 seconds, international normalized ratio (INR) above 1.3, or clinically significant fibrinogen abnormality.
    6. (Cockcroft-Gault) 60 mL/min or less, or clinically significant proteinuria.
    7. Poorly controlled diabetes with (HbA1c) above 7.0%.
  15. AIDS, hepatitis A, B, C, or D, or positive screening for antibody, Treponema pallidum antibody, or hepatitis A, B, C, or D antibody; positive antibody requires HCV RNA testing, and positive HCV RNA excludes.
  16. Any potentially hepatotoxic drug (prescription, over-the-counter, or herbal) within 14 days (or 5 half-lives, if longer) before the first dose, if judged unsuitable by the investigator; stable therapy for hypertension or diabetes is allowed.
  17. Interferon or treatment within 12 months before screening, excluding short-term (2 weeks or less) use and topical or inhaled .
  18. within 1 month before screening.
  19. Small interfering RNA (siRNA) drug trial within 6 months, or other investigational drug within 3 months, before screening; or planned participation in another interventional trial.
  20. Severe intolerance to subcutaneous injection (mild local reactions are acceptable).
  21. Difficult venous access or venipuncture intolerance; history of syncope or hematophobia.
  22. Pregnancy, lactation, or positive pregnancy test at screening or baseline.
  23. Any scientific, compliance, or safety reason for which the investigator considers participation unsuitable.
  24. Inability to communicate or cooperate due to neurologic or psychiatric disorder or language barrier.
Terms in these criteria, in plain language(26)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
120 participants (estimated)

Study arms

  • Active comparator
    YKYY013

    Drug: YKYY013 Injection Administration method: Administer subcutaneous injections according to the dose groups A/B/C/D every 4 weeks until the 48th week.

    Drug: YKYY013

  • Placebo comparator
    YKYY013 Placebo

    Drug: 0.9% Sodium Chloride Injection Administration method: Administer subcutaneous injections according to the dose groups A/B/C/D every 4 weeks until the 48th week.

    Drug: YKYY013 Placebo

Interventions

  • DrugYKYY013

    Drug: YKYY013 Injection Administration method: Administer subcutaneous injections according to the dose groups A/B/C/D every 4 weeks until the 48th week.

  • DrugYKYY013 Placebo

    Drug: 0.9% Sodium Chloride Injection Administration method: Administer subcutaneous injections according to the dose groups A/B/C/D every 4 weeks until the 48th week.

06

What researchers measure

Primary outcomes

  1. The proportion (percent) of participants who achieved serum HBsAg < LLOQ (0.05 IU/mL) and HBVDNA < LLOQ at the 24th week

    Time frame: Week 24

Secondary outcomes

  1. The proportion (percent) of trial participants who maintained sustained efficacy during the 24-week period after discontinuation of YKYY013 (the NA monotherapy period, up to W72) after completing the YKYY013 treatment course.

    Time frame: Week 72

  2. The proportion (percent) of participants who achieved serum HBsAg < LLOQ (0.05 IU/mL) and HBV DNA < LLOQ at the end of YKYY013 treatment.

    Time frame: Week 48

  3. The proportion (percent) of trial participants who met the NA drug discontinuation criteria and stopped all chronic hepatitis B treatments (YKYY013 and NA drugs) and maintained sustained efficacy during a 24-week period.

    Time frame: Week 72,Week 96

  4. The proportion (percent) of trial participants who met the discontinuation criteria for NA treatment at the 72nd week

    Time frame: Week 72

  5. Compared to the baseline level, the percentage (percent) of participants in the HBsAg test at different levels was reduced (e.g., ≥0.5, ≥1, ≥1.5, ≥2.0, ≥3 log10 IU/mL);

    Time frame: From the first day to the 96th week

  6. The detection values (IU/mL) of HBsAg;

    Time frame: From the first day to the 96th week

  7. The maximum reductions (IU/mL) of HBsAg from the baseline;

    Time frame: From the first day to the 96th week

  8. The relative changes (IU/mL)of HBsAg from the baseline;

    Time frame: From the first day to the 96th week

  9. The detection values (copies/ml) of HBV RNA;

    Time frame: From the first day to the 96th week

  10. The maximum reductions (copies/ml) of HBV RNA from the baseline;

    Time frame: From the first day to the 96th week

  11. The relative changes (copies/ml) of HBV RNA from the baseline;

    Time frame: From the first day to the 96th week

  12. The detection values (U/mL) of HBcrAg;

    Time frame: From the first day to the 96th week

  13. The maximum reductions (U/mL) of HBcrAg from the baseline;

    Time frame: From the first day to the 96th week

  14. The relative changes (U/mL) of HBcrAg from the baseline;

    Time frame: From the first day to the 96th week

  15. The detection values (IU/mL) of HBV DNA;

    Time frame: From the first day to the 96th week

  16. The maximum reductions (IU/mL) of HBV DNA from the baseline;

    Time frame: From the first day to the 96th week

  17. The relative changes (IU/mL) of HBV DNA from the baseline;

    Time frame: From the first day to the 96th week

  18. The number and percentage (percent) of trial participants whose HBsAg and/or HBV DNA levels have dropped below the quantitative limit;

    Time frame: From the first day to the 96th week

  19. The number and percentage (percent) of trial participants whose highly sensitive HBsAg (LLOQ ≤ 0.005 IU/mL) decreased below the quantitative limit;

    Time frame: From the first day to the 96th week

  20. The positive rate (percent) and detection concentration (IU/L) of hepatitis B virus surface antibody (HBsAb);

    Time frame: From the first day to the 96th week

  21. The positive rate (percent) of hepatitis B virus e antibody (HBeAb).

    Time frame: From the first day to the 96th week

  22. Adverse events during treatment (TEAE)

    Time frame: From the first day to the 96th week

  23. Number of participants with abnormally elevated body temperature.

    Time frame: From the first day to the 96th week

  24. Number of participants with reactions at the injection site from prior administration.

    Time frame: From the first day to the 96th week

  25. Number of participants with abnormal time between the start of the q wave and the end of the t wave (QT/QTc interval) on 12-lead electrocardiogram (ECG).

    Time frame: From the first day to the 96th week

  26. Number of participants with liver function abnormalities during the treatment period.

    Time frame: From the first day to the 96th week

  27. The number and proportion of participants with positive anti-drug antibodies (ADA).

    Time frame: Day 1, Day 169, Day 337, Day 505, Day 673, or Early Termination; sampling time windows consistent with visit windows; pre-dose on dosing days

07

Study locations

1 site
  • Beijing Friendship Hospital, affiliated with Capital Medical University
    Beijing, Beijing Municipality 100050, China
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Mar 2027, 4 months later.

Of 40 industry-sponsored phase 2 interventional studies under Hepatitis B, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 40. This study's planned 4 months is below that.

Counting every sponsor, half of 50 studies reached it within 30 months; a quarter within 19 and three quarters within 40.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 21, 2026
First posted
Nov 12, 2026
StartEst.
Oct 30, 2026
Primary completionEst.
Mar 20, 2027
CompletionEst.
Mar 14, 2029
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07933627
Responsible party
Sponsor
First posted
Nov 12, 2026
Start date
Oct 30, 2026 (estimated)
Primary completion
Mar 20, 2027 (estimated)
Completion
Mar 14, 2029 (estimated)
Last update
Nov 12, 2026

Study contacts

Yuting Zhou
Contact
zhouyuting@bjykkc.com
+86 18606417018

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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