A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
NCT07920861, Phase 1, Recruiting, Huabo Biopharm Co., Ltd.
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose | ClinicalTrials.gov |
| NCT number | NCT07920861 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Phase 1 | ClinicalTrials.gov |
| Enrollment | 90 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Huabo Biopharm Co., Ltd. | ClinicalTrials.gov |
| Conditions | Psoriasis, Ankylosing Spondylitis | ClinicalTrials.gov |
| Interventions | HB0017 Injection, HB0017 Placebo | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-06 | ClinicalTrials.gov |
Registered outcomes 12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Adverse events | through study completion | PART 1: Number of participants experiencing adverse events as assessed by CTCAE v5.0. | ClinicalTrials.gov |
| Primary | Cmax | From pre-dosing to 140 days post-dosing | PART 2:Cmax was the maximum observed plasma concentration directly observed from data. Data analysis by group across injection sites - abdomen, upper arm, thigh - at the same dose. | ClinicalTrials.gov |
| Primary | AUCinf | From pre-dosing to 140 days post-dosing | PART 2 : AUCinf was area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf , if data permits).Data analysis by group across injection sites - abdomen, upper arm, thigh - at the same dose. | ClinicalTrials.gov |
| Secondary | AUC | From pre-dosing to 140 days post-dosing | PART 1: Area under the plasma concentration-time curve, reflecting total systemic drug exposure. | ClinicalTrials.gov |
| Secondary | Cmax | From pre-dosing to 140 days post-dosing | PART 1: Maximum observed plasma concentration after drug administration. | ClinicalTrials.gov |
| Secondary | Tmax | From pre-dosing to 140 days post-dosing | PART 1: Time to reach the maximum observed plasma concentration after drug administration. | ClinicalTrials.gov |
| Secondary | Vz | From pre-dosing to 140 days post-dosing | PART 1: Apparent volume of distribution during the terminal elimination phase; a theoretical volume relating the amount of drug in the body to the plasma concentration. | ClinicalTrials.gov |
| Secondary | CL | From pre-dosing to 140 days post-dosing | PART 1: Volume of plasma cleared of drug per unit time, reflecting total systemic clearance. | ClinicalTrials.gov |
| Secondary | t1/2 | From pre-dosing to 140 days post-dosing | PART 1: Time required for plasma drug concentration to decrease by 50% during the terminal elimination phase. | ClinicalTrials.gov |
| Secondary | Adverse events | through study completion (approximately 140 days) | PART 2: Number of participants experiencing adverse events as assessed by CTCAE v5.0. | ClinicalTrials.gov |
| Secondary | ADA | through study completion (approximately 140 days) | Number and percentage of participants with a positive anti-drug antibody (ADA) result. | ClinicalTrials.gov |
| Secondary | Nab | through study completion (approximately 140 days) | Number and percentage of participants with a positive neutralizing antibody (NAb) 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)