A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
NCT07918456, Phase 1, Enrolling by invitation, Jiangsu Chuangyuan Life Science and Technology Co., Ltd.
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B. | ClinicalTrials.gov |
| NCT number | NCT07918456 | ClinicalTrials.gov |
| Status | Enrolling by invitation | ClinicalTrials.gov |
| Phases | Phase 1 | ClinicalTrials.gov |
| Enrollment | 74 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Jiangsu Chuangyuan Life Science and Technology Co., Ltd. | ClinicalTrials.gov |
| Conditions | Chronic Hepatitis B | ClinicalTrials.gov |
| Interventions | CPU-YL01 Injection Intramuscular administration, Placebo intramuscular injection | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-05 | ClinicalTrials.gov |
Registered outcomes 178
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | adverse events [Safety and Tolerability Evaluation Endpoints] | For single-dose administration, observations will extend up to Day29 after the first dose; for multiple-dose administration, observations will extend up to Day337 after the first dose. | adverse events | ClinicalTrials.gov |
| Primary | serious adverse events [Safety and Tolerability Evaluation Endpoints] | For single-dose administration, observations will extend up to Day29 after the first dose; for multiple-dose administration, observations will extend up to Day337 after the first dose. | serious adverse events | ClinicalTrials.gov |
| Primary | adverse events of particular concern (AESI) [Safety and Tolerability Evaluation Endpoints] | For single-dose administration, observations will extend up to Day29 after the first dose; for multiple-dose administration, observations will extend up to Day337 after the first dose. | adverse events of particular concern (AESI) | ClinicalTrials.gov |
| Primary | vital signs-Blood Pressure (mmHg) [Safety and Tolerability Evaluation Endpoints] | Single-dose: Screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose:Screening, Day-1, Day1,Day 2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337. | vital signs-Blood Pressure (mmHg) | ClinicalTrials.gov |
| Primary | vital signs-respiratory rate (breaths/min) [Safety and Tolerability Evaluation Endpoints] | Single-dose: Screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: Screening, Day-1, Day1,Day 2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337. | vital signs-respiratory rate (breaths/min) | ClinicalTrials.gov |
| Primary | vital signs-body temperature (°C) [Safety and Tolerability Evaluation Endpoints] | Single-dose: Screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: Screening, Day-1, Day1,Day 2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337. | vital signs-body temperature (°C) | ClinicalTrials.gov |
| Primary | vital signs-pulse rate (beats/min) [Safety and Tolerability Evaluation Endpoints] | Single-dose: Screening, Day-1, Day1, Day2, Day3, Day8, Day15, Day22, Day29. Multiple-dose: Screening, Day-1, Day1,Day 2, Day3, Day8, Day36, Day29, Day57, Day85, Day113, Day141, Day142, Day143, Day148, Day169, Day225, Day281, and Day337. | vital signs-pulse rate (beats/min) | ClinicalTrials.gov |
| Primary | physical examination- skin- Color abnormalities-jaundice -The number of participants with or without skin Color abnormalities- jaundice [Safety and Tolerability Evaluation Endpoints] | Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337. | physical examination- skin-Color abnormalities: jaundice. The number of participants with or without skin Color abnormalities: jaundice will be reported by category. | ClinicalTrials.gov |
| Primary | physical examination- skin- Color abnormalities-pallor- The number of participants with or without skin Color abnormalities: pallor [Safety and Tolerability Evaluation Endpoints] | Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337. | physical examination- skin- Color abnormalities: pallor. The number of participants with or without skin Color abnormalities: pallor will be reported by category. | ClinicalTrials.gov |
| Primary | physical examination- skin-Color abnormalities-pigmentation- The number of participants with or without skin Color abnormalities:pigmentation [Safety and Tolerability Evaluation Endpoints] | Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337. | physical examination- skin-Color abnormalities : pigmentation. The number of participants with or without skin Color abnormalities:pigmentation will be reported by category. | ClinicalTrials.gov |
| Primary | physical examination- skin-Morphological abnormalities- rash-The number of participants with or without -Morphological abnormalities: rash [Safety and Tolerability Evaluation Endpoints] | Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337. | physical examination- skin-Morphological abnormalities: rash . The number of participants with or without -Morphological abnormalities: rash will be reported by category. | ClinicalTrials.gov |
| Primary | physical examination- skin-Morphological abnormalities-erythema at injection site -The number of participants with or without -Morphological abnormalities: erythema at injection site [Safety and Tolerability Evaluation Endpoints] | Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337. | physical examination- skin-Morphological abnormalities: erythema at injection site. The number of participants with or without -Morphological abnormalities: erythema at injection site will be reported by category. | ClinicalTrials.gov |
| Primary | physical examination- skin-Morphological abnormalities: induration at injection site- The number of participants with or without -Morphological abnormalities: induration at injection site [Safety and Tolerability Evaluation Endpoints] | Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337. | physical examination- skin-Morphological abnormalities: induration at injection site. The number of participants with or without -Morphological abnormalities: induration at injection site will be reported by category. | ClinicalTrials.gov |
| Primary | physical examination-mucous membranes-Ocular conjunctiva: assessment for scleral icterus- The number of participants with or without -Ocular conjunctiva-scleral icterus [Safety and Tolerability Evaluation Endpoints] | Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337. | physical examination-mucous membranes- Ocular conjunctiva: assessment for scleral icterus. The number of participants with or without -Ocular conjunctiva-scleral icterus will be reported by category. | ClinicalTrials.gov |
| Primary | physical examination-mucous membranes- Ocular conjunctiva: assessment for conjunctival pallor-The number of participants with or without -Ocular conjunctiva-conjunctival pallor [Safety and Tolerability Evaluation Endpoints] | Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337. | physical examination-mucous membranes-Ocular conjunctiva: assessment for conjunctival pallor. The number of participants with or without -Ocular conjunctiva-conjunctival pallor will be reported by category. | ClinicalTrials.gov |
| Primary | physical examination-mucous membranes-Oral mucosa: assessment for petechiae-The number of participants with or without Oral mucosa-petechiae [Safety and Tolerability Evaluation Endpoints] | Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337. | physical examination-mucous membranes-Oral mucosa: assessment for petechiae. The number of participants with or without Oral mucosa-petechiae will be reported by category. | ClinicalTrials.gov |
| Primary | physical examination-mucous membranes-Oral mucosa: assessment for ulceration-The number of participants with or without Oral mucosa-ulceration [Safety and Tolerability Evaluation Endpoints] | Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337. | physical examination-mucous membranes-Oral mucosa: assessment for ulceration. The number of participants with or without Oral mucosa-ulceration will be reported by category. | ClinicalTrials.gov |
| Primary | physical examination-mucous membranes- Oral mucosa: assessment for fungal infection-The number of participants with or without Oral mucosa-fungal infection [Safety and Tolerability Evaluation Endpoints] | Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337. | physical examination-mucous membranes-Oral mucosa: assessment for fungal infection. The number of participants with or without Oral mucosa-fungal infection will be reported by category. | ClinicalTrials.gov |
| Primary | physical examination-lymph nodes- lymph nodes enlargement -The number of participants with or without lymph nodes enlargement [Safety and Tolerability Evaluation Endpoints] | Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337. | physical examination-lymph nodes enlargement. The number of participants with or without lymph nodes enlargement will be reported by category. (Among participants with enlarged lymph nodes, findings for lymph node consistency, mobility and tenderness will also be summarized.) | ClinicalTrials.gov |
| Primary | physical examination-lymph nodes- Lymph Node Consistency(Participants with Enlarged Lymph Nodes)- The number of participants with lymph node consistency- soft, firm, hard. [Safety and Tolerability Evaluation Endpoints] | Single-dose: screening phase and then on Day-1, Day3, Day15, Day29. Multiple-dose: screening phase and then on Day-1, Day3, Day8, Day29,Day36, Day57, Day85, Day113, Day141, Day169, Day225, Day281, Day337. | physical examination-lymph nodes- Assessment of lymph node consistency (soft, firm, hard). Among participants with enlarged lymph nodes, lymph node consistency will be assessed (soft, firm, hard). The number of participants in each consistency category will be reported. | 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 7
The papers the trial lists on ClinicalTrials.gov.
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)