A Phase 1 interventional study of Recombinant Human Interleukin-2 Fusion Protein with Human Serum Albumin (VDJ010) and Placebo in Ulcerative Colitis (UC), sponsored by Beijing VDJBio Co., LTD.. Recruiting at 6 sites in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Beijing VDJBio Co., LTD. · Phase 1, Interventional, and Treatment
Among 183 studies in Colitis, Ulcerative with a site in China — 72 open to participants now, 95 under way, 25 of them phase 3. Colitis, Ulcerative · China.
Among the 183 studies in Colitis, Ulcerative with a site in China, this one is the 105th largest by planned enrollment of the 135 interventional ones that give a count, is one of 19 that started in 2024, is one of 18 in phase 1, reaches primary completion later than 77 of the 94 other live ones, and was the 183rd registered.
1,854 studies on the registry are indexed under Colitis, Ulcerative; 473 are open to participants now.
Browse Colitis, Ulcerative studies →72 of the 183 studies in Colitis, Ulcerative with a site in China are open now. Recruiting first, the newest first:
Accro Bioscience (Suzhou) Limited · Sites in China
Ages 18–75
Nanjing Immunophage Biotech Co., Ltd · Sites in China
Ages 18–70
Second Affiliated Hospital of Wenzhou Medical University · Sites in China
Ages 18+
The Second Hospital of Nanjing Medical University · Sites in China
Ages 18–75
Innatus Therapeutics (Shanghai) Co., Ltd. · Sites in China
Ages 18–75
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 →
Of the 307 Colitis, Ulcerative studies recruiting now, 134 (44%) set no upper age limit and 136 (44%) stop at 75 or younger; 71 take children under 18; 41 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
183 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 25 · Phase 2 46 · Phase 3 37 · Phase 4 11
First in 2009; this study’s year is marked. 19 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 48 is below the median of 70 across 1,237 interventional studies indexed under Colitis, Ulcerative.
Median enrollment 120 across the 135 interventional studies, 176 across the 48 observational. Of the 58 that completed or were terminated, 15 (26%) have results posted.
This tab as a report to print or save as PDF → With an account.
83 of 183 have an industry lead sponsor. The 10 most frequent:
Beijing VDJBio Co., LTD. is the lead sponsor of 7 studies on the registry; 4 are open to participants now.
Beijing VDJBio Co., LTD. has 1 study filed under Colitis, Ulcerative — fewer than ten, so there is no comparison to draw.
26 of the studies in Colitis, Ulcerative with a site in China that are under way reach primary completion within a year, 5 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06589986Phase 3Hoffmann-La RocheA Study to Assess the Efficacy and Safety of Afimkibart (Also Known as RO7790121) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis | 2027-01-30 |
| NCT06260163Phase 3Janssen Research & Development, LLCA Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis | 2027-02-10 |
| NCT03006068Phase 3AbbVieA Study to Evaluate the Long-Term Safety and Efficacy of Upadacitinib (ABT-494) in Participants With Ulcerative Colitis (UC) | 2027-07 |
| NCT06880744Phase 3AbbVieA Study to Assess the Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis Treated With Risankizumab Compared to Vedolizumab | 2027-08 |
| NCT03221036Phase 3TakedaEfficacy and Safety of Vedolizumab IV in Chinese Participants With Ulcerative Colitis | 2027-09-24 |
Add all 26 to your calendar (.ics) → With an account.
Among the 183 studies in Colitis, Ulcerative with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study adopted a multi-center, randomized, double-blind, placebo-controlled, single- and multiple-ascending dose design, using recombinant human IL-2 fusion protein (VDJ010) administered subcutaneously to evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy Chinese subjects and patients with ulcerative colitis.
This study is a first-in-human, Phase I, multi-center, double-blind, placebo-controlled, single- and multiple-ascending dose trial designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of subcutaneously administered VDJ010 (recombinant human fusion protein) in two parts: Part A enrolls 28 healthy subjects across four single-dose cohorts (500K, 750K, 1,000K, and 1,250/1,500K IU), and Part B enrolls 20 patients with moderately to severely active ulcerative colitis across three multiple-dose cohorts (750K, 1,000K, and 1,250/1,500K IU) dosed subcutaneously every two weeks for a total of three doses. The primary objective is to assess safety and tolerability, while secondary objectives include characterizing PK profiles, immunogenicity (ADA/NAB), and PD effects measured by changes in peripheral blood Treg, Tcon, NK, and B cell subsets. Exploratory efficacy endpoints in UC patients include clinical response and remission rates based on modified Mayo score, endoscopic remission, UCEIS score, IBDQ quality of life, and biomarkers such as CRP and fecal calprotectin at Week 8. Dose escalation follows predefined safety stopping criteria with review intervals between cohorts, and all safety assessments are conducted per CTCAE V6.0 through 43 days (healthy) or 57 days (UC) of follow-up.
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.
Healthy Subjects:
UC Patients:
Oral 5-ASA agents: stable dose ≥ 2 weeks; Oral (prednisolone ≤ 25 mg/day or equivalent): stable dose ≥ 2 weeks Oral budesonide (≤ 9 mg/day): stable dose ≥ 2 weeks; Oral immunomodulators (MTX, AZA, 6-MP): stable dose ≥ 12 weeks
Exclusion Criteria:
Healthy Subjects:
Oral use within 30 days or planned during study; Long-acting estrogen/progestin injection, contraceptive patch, vaginal ring, subcutaneous implant, or contraceptive injection within 6 months; Unprotected intercourse within 14 days prior to randomization; Pregnancy or lactation; Plans for pregnancy, sperm/egg donation during the study or within 3 months after study completion
UC Patients
Significant laboratory abnormalities:
\< 80 g/L; WBC \< 2.5×10⁹/L; Platelets \< 100×10⁹/L; Clinically significant ECG abnormalities: PR ≥ 210 ms, QRS ≥ 120 ms, QTcF \< 350 ms or ≥ 450 ms (Fridericia correction); Creatinine ≥ 1.5×ULN; Total > 34.2 μmol/L; ALT or AST > 2×ULN; GGT > 2×ULN; Abnormal thyroid function (hyper- or hypothyroidism)
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.
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.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 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.
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.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
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.
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.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Recombinant Human Interleukin-2 Fusion Protein with Human Serum Albumin (VDJ010)
Drug: Placebo
VDJ010 is a recombinant fusion protein consisting of human interleukin-2 (IL-2) genetically fused to human serum albumin (HSA), produced using Chinese hamster ovary (CHO) cells through DNA recombinant technology. The fusion protein selectively binds to the high-affinity IL-2 receptor (IL-2Rαβγ) constitutively expressed on regulatory T cells (Treg), thereby promoting Treg expansion and restoring immune tolerance in autoimmune diseases such as ulcerative colitis. The HSA moiety extends the plasma half-life of IL-2 to enable less frequent subcutaneous dosing.
This is a matching placebo formulation containing no active pharmaceutical ingredient (API). The placebo is manufactured to be identical in appearance, color, shape, size, and packaging to the investigational product VDJ010 to maintain the integrity of the double-blind design. It is utilized solely as a control intervention for the purpose of this randomized, double-blind, placebo-controlled Phase I clinical trial.
Safety and tolerability
Incidence and severity of adverse events
Time frame: First dose up to last follow-up visit (Healthy Subjects: 43 days after administration; UC Patients: 57 days after administration)
Peak Serum Concentration (Cmax)
VDJ010 Cmax; assessed in healthy subjects (single dose) and UC patients (multiple-dose steady-state, Cmax,ss)
Time frame: Healthy Subjects: 43 days after administration; UC Patients: 57 days after administration.
Time to Peak Concentration (Tmax)
VDJ010 Tmax; assessed in healthy subjects (single dose) and UC patients (multiple-dose steady-state, Tmax,ss)
Time frame: Healthy Subjects: 43 days after administration; UC Patients: 57 days after administration.
Area Under the Serum Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC0-t)
VDJ010 AUC0-t; assessed in healthy subjects (single dose) and UC patients (multiple-dose steady-state, AUC0-t,ss)
Time frame: Healthy Subjects: 43 days after administration; UC Patients: 57 days after administration
Area Under the Serum Concentration-Time Curve from Time Zero to Infinity (AUC0-∞)
VDJ010 AUC0-∞; assessed in healthy subjects (single dose) and UC patients (multiple-dose steady-state, AUC0-∞,ss)
Time frame: Healthy Subjects: 43 days after administration; UC Patients: 57 days after administration
Terminal Elimination Rate Constant (λz)
VDJ010 λz; assessed in healthy subjects (single dose) and UC patients (multiple-dose steady-state)
Time frame: Healthy Subjects: 43 days after administration; UC Patients: 57 days after administration
Terminal Elimination Half-Life (t1/2z)
VDJ010 t1/2z; assessed in healthy subjects (single dose) and UC patients (multiple-dose steady-state)
Time frame: Healthy Subjects: 43 days after administration; UC Patients: 57 days after administration
Clearance (CLz)
VDJ010 CLz; assessed in healthy subjects (single dose)
Time frame: Healthy Subjects: 43 days after administration; UC Patients: 57 days after administration
Trough Concentration at Steady State (Cmin,ss / Ctrough,ss)
VDJ010 Cmin,ss (Ctrough,ss); assessed in UC patients at steady state
Time frame: Healthy Subjects: 43 days after administration; UC Patients: 57 days after administration
Area Under the Curve over One Dosing Interval at Steady State (AUC0-τ,ss)
VDJ010 AUC0-τ,ss; assessed in UC patients at steady state
Time frame: Healthy Subjects: 43 days after administration; UC Patients: 57 days after administration
Average Concentration at Steady State (Cav,ss)
VDJ010 Cav,ss; assessed in UC patients at steady state
Time frame: Healthy Subjects: 43 days after administration; UC Patients: 57 days after administration
Degree of Fluctuation (DF)
VDJ010 degree of fluctuation (DF); assessed in UC patients at steady state
Time frame: Healthy Subjects: 43 days after administration; UC Patients: 57 days after administration
Swing
VDJ010 Swing; assessed in UC patients at steady state.
Time frame: Healthy Subjects: 43 days after administration; UC Patients: 57 days after administration
Apparent Volume of Distribution at Steady State (Vss/F)
VDJ010 Vss/F; assessed in UC patients at steady state
Time frame: Healthy Subjects: 43 days after administration; UC Patients: 57 days after administration
Apparent Clearance at Steady State (CLss/F)
VDJ010 CLss/F; assessed in UC patients at steady state
Time frame: Healthy Subjects: 43 days after administration; UC Patients: 57 days after administration
Percentage of AUC Extrapolated to Infinity (AUC_%Extrap)
Percentage of AUC extrapolated to infinity (AUC\_%Extrap); assessed in healthy subjects (single dose) and UC patients (multiple-dose steady-state)
Time frame: Healthy Subjects: 43 days after administration; UC Patients: 57 days after administration
Mean Residence Time to Infinity (MRT0-∞)
VDJ010 MRT0-∞; assessed in healthy subjects (single dose) and UC patients (multiple-dose steady-state)
Time frame: Healthy Subjects: 43 days after administration; UC Patients: 57 days after administration
Accumulation Ratio Based on Cmax (Ra(Cmax))
VDJ010 accumulation ratio based on Cmax (Ra(Cmax)); assessed in UC patients
Time frame: Healthy Subjects: 43 days after administration; UC Patients: 57 days after administration
Accumulation Ratio Based on AUC (Ra(AUC))
VDJ010 accumulation ratio based on AUC (Ra(AUC)); assessed in UC patients
Time frame: Healthy Subjects: 43 days after administration; UC Patients: 57 days after administration
Immunogenicity
ADA and NAb incidence and percentage of positive ADA/NAB subjects; ADA titers; time from dosing to first ADA-positive result.
Time frame: Healthy Subjects: 43 days after administration; UC Patients: 57 days after administration
Pharmacodynamics
Changes from baseline in the percentages of peripheral blood Treg, Tcon, NK, and B cells.
Time frame: Healthy Subjects: Pre-dose to D20; UC Patients: Pre-dose to D43.
The modified Mayo score
Percentage of participants achieving clinical remission, clinical response, endoscopic remission, and mucosal healing at Week 8, as defined by the modified Mayo score (based on screening values).
Time frame: First dose up to last follow-up visit (Day1-Day57）
The modified Mayo score
Changes from baseline in the modified Mayo score at Week 8.
Time frame: First dose up to last follow-up visit (Day1-Day57）
The endoscopic subscore
Changes from baseline in the endoscopic subscore at Week 8.
Time frame: First dose up to last follow-up visit (Day1-Day57）
The Ulcerative Colitis Endoscopic Index of Severity (UCEIS)
Changes from baseline in the UCEIS at Week 8.
Time frame: First dose up to last follow-up visit (Day1-Day57）
The partial modified Mayo score (excluding endoscopy)
Percentage of participants achieving symptom relief based on the partial modified Mayo score (excluding endoscopy) at Weeks 1, 2, 4, 6, and 8.
Time frame: First dose up to last follow-up visit (Day1-Day57）
The Bowel Disease Questionnaire (IBDQ) score
Changes from baseline in IBDQ score at Weeks 2, 4, 6, and 8.
Time frame: First dose up to last follow-up visit (Day1-Day57）
C-reactive protein (CRP)/high-sensitivity CRP (hs-CRP)
Changes from baseline in CRP/hs-CRP and FC at Weeks 1, 2, 4, 6, and 8.
Time frame: First dose up to last follow-up visit (Day1-Day57）
Fecal calprotectin (FC)
Changes from baseline in CRP/hs-CRP and FC at Weeks 1, 2, 4, 6, and 8.
Time frame: First dose up to last follow-up visit (Day1-Day57）
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2024 (actual). Primary completion is estimated for Nov 2028, 51 months after the start.
Of 58 industry-sponsored phase 1 interventional studies under Colitis, Ulcerative, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 18. This study's planned 51 months is above that.
Counting every sponsor, half of 84 studies reached it within 13 months; a quarter within 8 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
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 ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
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