Phase I Trial of Subcutaneous VDJ010 In Healthy Subjects and Patients With Ulcerative Colitis
NCT07932691, Phase 1, Recruiting, Beijing VDJBio Co., LTD.
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Phase I Trial of Subcutaneous VDJ010 In Healthy Subjects and Patients With Ulcerative Colitis | ClinicalTrials.gov |
| NCT number | NCT07932691 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Phase 1 | ClinicalTrials.gov |
| Enrollment | 48 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Beijing VDJBio Co., LTD. | ClinicalTrials.gov |
| Conditions | Ulcerative Colitis (UC) | ClinicalTrials.gov |
| Interventions | Recombinant Human Interleukin-2 Fusion Protein with Human Serum Albumin (VDJ010), Placebo | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Safety and tolerability | First dose up to last follow-up visit (Healthy Subjects: 43 days after administration; UC Patients: 57 days after administration) | Incidence and severity of adverse events | ClinicalTrials.gov |
| Primary | Peak Serum Concentration (Cmax) | Healthy Subjects: 43 days after administration; UC Patients: 57 days after administration. | VDJ010 Cmax; assessed in healthy subjects (single dose) and UC patients (multiple-dose steady-state, Cmax,ss) | ClinicalTrials.gov |
| Primary | Time to Peak Concentration (Tmax) | Healthy Subjects: 43 days after administration; UC Patients: 57 days after administration. | VDJ010 Tmax; assessed in healthy subjects (single dose) and UC patients (multiple-dose steady-state, Tmax,ss) | ClinicalTrials.gov |
| Primary | Area Under the Serum Concentration-Time Curve from Time Zero to Last Quantifiable Concentration (AUC0-t) | Healthy Subjects: 43 days after administration; UC Patients: 57 days after administration | VDJ010 AUC0-t; assessed in healthy subjects (single dose) and UC patients (multiple-dose steady-state, AUC0-t,ss) | ClinicalTrials.gov |
| Primary | Area Under the Serum Concentration-Time Curve from Time Zero to Infinity (AUC0-∞) | Healthy Subjects: 43 days after administration; UC Patients: 57 days after administration | VDJ010 AUC0-∞; assessed in healthy subjects (single dose) and UC patients (multiple-dose steady-state, AUC0-∞,ss) | ClinicalTrials.gov |
| Primary | Terminal Elimination Rate Constant (λz) | Healthy Subjects: 43 days after administration; UC Patients: 57 days after administration | VDJ010 λz; assessed in healthy subjects (single dose) and UC patients (multiple-dose steady-state) | ClinicalTrials.gov |
| Primary | Terminal Elimination Half-Life (t1/2z) | Healthy Subjects: 43 days after administration; UC Patients: 57 days after administration | VDJ010 t1/2z; assessed in healthy subjects (single dose) and UC patients (multiple-dose steady-state) | ClinicalTrials.gov |
| Primary | Clearance (CLz) | Healthy Subjects: 43 days after administration; UC Patients: 57 days after administration | VDJ010 CLz; assessed in healthy subjects (single dose) | ClinicalTrials.gov |
| Primary | Trough Concentration at Steady State (Cmin,ss / Ctrough,ss) | Healthy Subjects: 43 days after administration; UC Patients: 57 days after administration | VDJ010 Cmin,ss (Ctrough,ss); assessed in UC patients at steady state | ClinicalTrials.gov |
| Primary | Area Under the Curve over One Dosing Interval at Steady State (AUC0-τ,ss) | Healthy Subjects: 43 days after administration; UC Patients: 57 days after administration | VDJ010 AUC0-τ,ss; assessed in UC patients at steady state | ClinicalTrials.gov |
| Primary | Average Concentration at Steady State (Cav,ss) | Healthy Subjects: 43 days after administration; UC Patients: 57 days after administration | VDJ010 Cav,ss; assessed in UC patients at steady state | ClinicalTrials.gov |
| Primary | Degree of Fluctuation (DF) | Healthy Subjects: 43 days after administration; UC Patients: 57 days after administration | VDJ010 degree of fluctuation (DF); assessed in UC patients at steady state | ClinicalTrials.gov |
| Primary | Swing | Healthy Subjects: 43 days after administration; UC Patients: 57 days after administration | VDJ010 Swing; assessed in UC patients at steady state. | ClinicalTrials.gov |
| Primary | Apparent Volume of Distribution at Steady State (Vss/F) | Healthy Subjects: 43 days after administration; UC Patients: 57 days after administration | VDJ010 Vss/F; assessed in UC patients at steady state | ClinicalTrials.gov |
| Primary | Apparent Clearance at Steady State (CLss/F) | Healthy Subjects: 43 days after administration; UC Patients: 57 days after administration | VDJ010 CLss/F; assessed in UC patients at steady state | ClinicalTrials.gov |
| Primary | Percentage of AUC Extrapolated to Infinity (AUC_%Extrap) | Healthy Subjects: 43 days after administration; UC Patients: 57 days after administration | Percentage of AUC extrapolated to infinity (AUC\_%Extrap); assessed in healthy subjects (single dose) and UC patients (multiple-dose steady-state) | ClinicalTrials.gov |
| Primary | Mean Residence Time to Infinity (MRT0-∞) | Healthy Subjects: 43 days after administration; UC Patients: 57 days after administration | VDJ010 MRT0-∞; assessed in healthy subjects (single dose) and UC patients (multiple-dose steady-state) | ClinicalTrials.gov |
| Primary | Accumulation Ratio Based on Cmax (Ra(Cmax)) | Healthy Subjects: 43 days after administration; UC Patients: 57 days after administration | VDJ010 accumulation ratio based on Cmax (Ra(Cmax)); assessed in UC patients | ClinicalTrials.gov |
| Primary | Accumulation Ratio Based on AUC (Ra(AUC)) | Healthy Subjects: 43 days after administration; UC Patients: 57 days after administration | VDJ010 accumulation ratio based on AUC (Ra(AUC)); assessed in UC patients | ClinicalTrials.gov |
| Primary | Immunogenicity | Healthy Subjects: 43 days after administration; UC Patients: 57 days after administration | ADA and NAb incidence and percentage of positive ADA/NAB subjects; ADA titers; time from dosing to first ADA-positive result. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)