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RecruitingNCT07920861Updated Nov 6, 2026

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

A Phase 1 interventional study of HB0017 Injection and HB0017 Placebo in Psoriasis and Ankylosing Spondylitis, sponsored by Huabo Biopharm Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by Huabo Biopharm Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Jan 2026, registered Oct 2026).
  • Started Jan 2026; still recruiting 9 months later.
Updated Nov 6, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Psoriasis
  • Ankylosing Spondylitis
03

In context

Psoriasis

2,028 studies on the registry are indexed under Psoriasis; 275 are open to participants now.

This study's planned enrollment of 90 is above the median of 75 across 1,565 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Huabo Biopharm Co., Ltd. is the lead sponsor of 15 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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.

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 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 measures, and have no plans to donate sperm or eggs.

Exclusion criteria

Exclusion Criteria:

  • to any component of the drug (including ), 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: surface antigen (HBsAg), hepatitis B e antigen (HBeAg), hepatitis B e antibody (HBeAb), hepatitis B core antibody (HBcAb), virus antibody (HCV Ab), 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 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.
Terms in these criteria, in plain language(9)

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.

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.

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.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

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.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

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.

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.

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.

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.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    PART1: Group 1,75mg

    single-dose, SC, HB0017 75 mg or placebo

    Biological: HB0017 Injection · Other: HB0017 Placebo

  • Experimental
    PART1: Group 2, 150mg

    single-dose, SC, HB0017 150 mg or placebo

    Biological: HB0017 Injection · Other: HB0017 Placebo

  • Experimental
    PART1: Group 3, 300mg

    single-dose, SC, HB0017 300 mg or placebo

    Biological: HB0017 Injection · Other: HB0017 Placebo

  • Experimental
    PART2: Group 4, 150mg, domen

    single-dose, SC at domen, HB0017 150 mg

    Biological: HB0017 Injection

  • Experimental
    PART2: Group 5, 150mg, upper arms

    single-dose, SC at upper arms, HB0017 150 mg

    Biological: HB0017 Injection

  • Experimental
    PART2: Group 6, 150mg, thihgs

    single-dose, SC at thighs, HB0017 150 mg

    Biological: HB0017 Injection

  • Experimental
    PART2: Group 7, 300mg, domen

    single-dose, SC at domen, HB0017 300 mg

    Biological: HB0017 Injection

  • Experimental
    PART2: Group 8, 300mg, upper arms

    single-dose, SC at upper arms, HB0017 300 mg

    Biological: HB0017 Injection

  • Experimental
    PART2: Group 9, 300mg, thighs

    single-dose, SC at thighs, HB0017 300 mg

    Biological: HB0017 Injection

Interventions

  • BiologicalHB0017 Injection

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

  • OtherHB0017 Placebo

    pre-filled syringe,1 mL/per injection

06

What researchers measure

Primary outcomes

  1. Adverse events

    PART 1: Number of participants experiencing adverse events as assessed by CTCAE v5.0.

    Time frame: through study completion

  2. Cmax

    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.

    Time frame: From pre-dosing to 140 days post-dosing

  3. AUCinf

    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.

    Time frame: From pre-dosing to 140 days post-dosing

Secondary outcomes

  1. AUC

    PART 1: Area under the plasma concentration-time curve, reflecting total systemic drug exposure.

    Time frame: From pre-dosing to 140 days post-dosing

  2. Cmax

    PART 1: Maximum observed plasma concentration after drug administration.

    Time frame: From pre-dosing to 140 days post-dosing

  3. Tmax

    PART 1: Time to reach the maximum observed plasma concentration after drug administration.

    Time frame: From pre-dosing to 140 days post-dosing

  4. Vz

    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.

    Time frame: From pre-dosing to 140 days post-dosing

  5. CL

    PART 1: Volume of plasma cleared of drug per unit time, reflecting total systemic clearance.

    Time frame: From pre-dosing to 140 days post-dosing

  6. t1/2

    PART 1: Time required for plasma drug concentration to decrease by 50% during the terminal elimination phase.

    Time frame: From pre-dosing to 140 days post-dosing

  7. Adverse events

    PART 2: Number of participants experiencing adverse events as assessed by CTCAE v5.0.

    Time frame: through study completion (approximately 140 days)

  8. ADA

    Number and percentage of participants with a positive anti-drug antibody (ADA) result.

    Time frame: through study completion (approximately 140 days)

  9. Nab

    Number and percentage of participants with a positive neutralizing antibody (NAb) result.

    Time frame: through study completion (approximately 140 days)

07

Study locations

1 of 1 sites recruiting
08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 6, 2026
Show all 1 update
  1. Nov 6, 2026
    First appeared on the registry

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 ↗

09

Registry details

Key details

Study ID
NCT07920861
Lead sponsor
Huabo Biopharm Co., Ltd.
Collaborators
Shanghai Huaota Biopharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Nov 6, 2026
Start date
Jan 19, 2026
Primary completion
Dec 31, 2026 (estimated)
Completion
Feb 28, 2027 (estimated)
Last update
Nov 6, 2026

Study contacts

Ying Wang, PhD
Contact
nancywangying@163.com
086-18367124548
Ying Wang, PhD
principal investigator · First People's Hospital of Hangzhou

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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