AzTrials
AzTrials

PsoriasisPhase 1NCT07920861

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 study testing HB0017 Injection in people with Psoriasis and Ankylosing Spondylitis, run by Huabo Biopharm Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Psoriasis, Ankylosing Spondylitis
What is being tested?
HB0017 Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
1 siteChina
Study dates
19 Jan 2026to 28 Feb 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ying Wang, PhD contact

086-18367124548

nancywangying@163.com

China1 site, 1 recruiting

  • First People's Hospital of Hangzhou

    Hangzhou, Zhejiang

    Ying Wang, PhD

    Recruiting

Other trials in China

About this study

Official title: 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.

Being tested
HB0017 Injection, HB0017 Placebo
Medical subject headings
Psoriasis, Spondylitis, Ankylosing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HB0017 InjectionBiological

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

  • HB0017 PlaceboOther

    pre-filled syringe,1 mL/per injection

Study groups in NCT07920861
Study groupRoleWhat they receive
PART1: Group 1,75mgExperimentalsingle-dose, SC, HB0017 75 mg or placebo
Receives: Biological: HB0017 Injection; Other: HB0017 Placebo
PART1: Group 2, 150mgExperimentalsingle-dose, SC, HB0017 150 mg or placebo
Receives: Biological: HB0017 Injection; Other: HB0017 Placebo
PART1: Group 3, 300mgExperimentalsingle-dose, SC, HB0017 300 mg or placebo
Receives: Biological: HB0017 Injection; Other: HB0017 Placebo
PART2: Group 4, 150mg, domenExperimentalsingle-dose, SC at domen, HB0017 150 mg
Receives: Biological: HB0017 Injection
PART2: Group 5, 150mg, upper armsExperimentalsingle-dose, SC at upper arms, HB0017 150 mg
Receives: Biological: HB0017 Injection
PART2: Group 6, 150mg, thihgsExperimentalsingle-dose, SC at thighs, HB0017 150 mg
Receives: Biological: HB0017 Injection
PART2: Group 7, 300mg, domenExperimentalsingle-dose, SC at domen, HB0017 300 mg
Receives: Biological: HB0017 Injection
PART2: Group 8, 300mg, upper armsExperimentalsingle-dose, SC at upper arms, HB0017 300 mg
Receives: Biological: HB0017 Injection
PART2: Group 9, 300mg, thighsExperimentalsingle-dose, SC at thighs, HB0017 300 mg
Receives: Biological: HB0017 Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events

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

    Measured: 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.

    Measured: 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.

    Measured: From pre-dosing to 140 days post-dosing

Secondary outcomes (9)

  1. AUC

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

    Measured: From pre-dosing to 140 days post-dosing

  2. Cmax

    PART 1: Maximum observed plasma concentration after drug administration.

    Measured: From pre-dosing to 140 days post-dosing

  3. Tmax

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

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: through study completion (approximately 140 days)

  8. ADA

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

    Measured: through study completion (approximately 140 days)

  9. Nab

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

    Measured: through study completion (approximately 140 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2026
  2. Study start19 Jan 2026
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion28 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07920861
Sponsor's protocol ID
HB0017-HV-01-02
Other IDs
CTR20255233
Status last verified
Nov 2026
First submitted
21 Oct 2026
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HB0017 Injection in people with Psoriasis and Ankylosing Spondylitis, run by Huabo Biopharm Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ying Wang, PhD (086-18367124548, nancywangying@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (time frame: through study completion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07920861.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in