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

November 2, 2026 updated by: Huabo Biopharm Co., Ltd.

A Study of HB0017 Injection to Investigate PK After Subcutaneous Administration at Different Injection Sites in Healthy Volunteers, and to Evaluate Its Safety, Tolerability, and Pharmacokinetics in Low-body-weight Healthy Subjects

The goal of this clinical trial is to (PART 1) to evaluate the safety and tolerability of a single subcutaneous injection of HB0017 Injection in healthy subjects with low body weight; ( PART 2) to compare the pharmacokinetics (PK) of HB0017 following single subcutaneous administration at different injection sites at the same dose.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • First People's Hospital of Hangzhou
        • Principal Investigator:
          • Ying Wang, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
  • PART1：bodyweight≤50 kg，at Screening；PART2：bodyweight at screening， female≥45 kg or male≥50 kg and BMI within 18~30（kg/m2）(including margin).
  • Subjects who are overtly healthy as determined by medical evaluation including medical history, physical examination, and laboratory tests.
  • Subjects (including male subjects) have no pregnancy plans during the screening period and within 6 months after dosing, voluntarily use effective contraceptive measures, and have no plans to donate sperm or eggs.

Exclusion Criteria:

  • Hypersensitivity to any component of the investigational drug (including excipients), or a history of severe allergic reaction to biologics, or at risk of allergic reactions upon study entry as judged by the investigator;
  • History of psychiatric disorders.
  • At screening, positive for any of the following in virological testing: hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), hepatitis B e antibody (HBeAb), hepatitis B core antibody (HBcAb), hepatitis C virus antibody (HCV Ab), human immunodeficiency virus antibody (HIV Ab), or syphilis test.
  • At screening, positive or equivocal interferon-gamma release assay (IGRA); or history of tuberculosis.
  • Prior expose to anti-IL-17 or anti-IL-17 receptor antibody.
  • Use of prescription or nonprescription drugs and dietary and herbal supplements within 2 weeks or 5 half lives (whichever is longer) prior to study intervention.
  • Vaccination with a live attenuated vaccine within 8 weeks before randomization, or planned vaccination with a live attenuated vaccine during the study;
  • Subjects deemed unsuitable for participation in this clinical trial by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PART1: Group 1,75mg

single-dose, SC, HB0017 75 mg or placebo
Biological: HB0017 Injection

pre-filled syringe, 150 mg/(1 mL)/per injection

Other: HB0017 Placebo

pre-filled syringe,1 mL/per injection
Experimental: PART1: Group 2, 150mg

single-dose, SC, HB0017 150 mg or placebo
Biological: HB0017 Injection

pre-filled syringe, 150 mg/(1 mL)/per injection

Other: HB0017 Placebo

pre-filled syringe,1 mL/per injection
Experimental: PART1: Group 3, 300mg

single-dose, SC, HB0017 300 mg or placebo
Biological: HB0017 Injection

pre-filled syringe, 150 mg/(1 mL)/per injection

Other: HB0017 Placebo

pre-filled syringe,1 mL/per injection
Experimental: PART2: Group 4, 150mg, domen

single-dose, SC at domen, HB0017 150 mg
Biological: HB0017 Injection

pre-filled syringe, 150 mg/(1 mL)/per injection
Experimental: PART2: Group 5, 150mg, upper arms

single-dose, SC at upper arms, HB0017 150 mg
Biological: HB0017 Injection

pre-filled syringe, 150 mg/(1 mL)/per injection
Experimental: PART2: Group 6, 150mg, thihgs

single-dose, SC at thighs, HB0017 150 mg
Biological: HB0017 Injection

pre-filled syringe, 150 mg/(1 mL)/per injection
Experimental: PART2: Group 7, 300mg, domen

single-dose, SC at domen, HB0017 300 mg
Biological: HB0017 Injection

pre-filled syringe, 150 mg/(1 mL)/per injection
Experimental: PART2: Group 8, 300mg, upper arms

single-dose, SC at upper arms, HB0017 300 mg
Biological: HB0017 Injection

pre-filled syringe, 150 mg/(1 mL)/per injection
Experimental: PART2: Group 9, 300mg, thighs

single-dose, SC at thighs, HB0017 300 mg
Biological: HB0017 Injection

pre-filled syringe, 150 mg/(1 mL)/per injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: through study completion

PART 1: Number of participants experiencing adverse events as assessed by CTCAE v5.0.
through study completion
Cmax
Time Frame: 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.
From pre-dosing to 140 days post-dosing
AUCinf
Time Frame: 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.
From pre-dosing to 140 days post-dosing

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUC
Time Frame: From pre-dosing to 140 days post-dosing

PART 1: Area under the plasma concentration-time curve, reflecting total systemic drug exposure.
From pre-dosing to 140 days post-dosing
Cmax
Time Frame: From pre-dosing to 140 days post-dosing

PART 1: Maximum observed plasma concentration after drug administration.
From pre-dosing to 140 days post-dosing
Tmax
Time Frame: From pre-dosing to 140 days post-dosing

PART 1: Time to reach the maximum observed plasma concentration after drug administration.
From pre-dosing to 140 days post-dosing
Vz
Time Frame: 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.
From pre-dosing to 140 days post-dosing
CL
Time Frame: From pre-dosing to 140 days post-dosing

PART 1: Volume of plasma cleared of drug per unit time, reflecting total systemic clearance.
From pre-dosing to 140 days post-dosing
t1/2
Time Frame: 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.
From pre-dosing to 140 days post-dosing
Adverse events
Time Frame: through study completion (approximately 140 days)

PART 2: Number of participants experiencing adverse events as assessed by CTCAE v5.0.
through study completion (approximately 140 days)
ADA
Time Frame: through study completion (approximately 140 days)

Number and percentage of participants with a positive anti-drug antibody (ADA) result.
through study completion (approximately 140 days)
Nab
Time Frame: through study completion (approximately 140 days)

Number and percentage of participants with a positive neutralizing antibody (NAb) result.
through study completion (approximately 140 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huabo Biopharm Co., Ltd.

Collaborators

Shanghai Huaota Biopharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Ying Wang, PhD, First People's Hospital of Hangzhou

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

February 28, 2027

Study Registration Dates

First Submitted

October 21, 2026

First Submitted That Met QC Criteria

November 2, 2026

First Posted (Actual)

November 6, 2026

Study Record Updates

Last Update Posted (Actual)

November 6, 2026

Last Update Submitted That Met QC Criteria

November 2, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HB0017-HV-01-02
  • CTR20255233 (Other Identifier: China Drug Clinical Trial Registry)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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