HB0017 Injection safety and PK in low-weight adults at different injection sites

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 interventional trial evaluates the safety and tolerability of a single subcutaneous HB0017 injection in healthy volunteers with low body weight and assesses pharmacokinetics after injections at different sites. Part 1 enrolls participants with body weight ≤50 kg at screening, while Part 2 includes those with higher screening weight and BMI between 18 and 30. Participants may receive HB0017 or placebo, with close monitoring for adverse events and laboratory changes. The study aims to determine how injection site affects drug absorption and clearance at the same dose.

Why it matters

Who can join: the full rules

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.

Where it's running

• First People's Hospital of Hangzhou
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Principal investigator: Ying Wang, PhD — First People's Hospital of Hangzhou
• Study coordinator: Ying Wang, PhD
• Email: nancywangying@163.com
• Phone: 086-18367124548

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Registry for evaluating a comprehensive approach to autoimmune disorders

  This study is testing a personalized treatment program for people with autoimmune disorders to see if combining different therapies helps them feel better over time.

  Recruiting AndHealth · Columbus, Ohio · NCT05883371

• Educational tool for melanoma patients with autoimmune diseases

  This study is testing a new educational tool to help melanoma patients with autoimmune diseases understand their treatment options better and see how easy it is for them to use.

  Recruiting M.D. Anderson Cancer Center · Houston, Texas · NCT04751396

• Surface topography and spine damage in radiographic axial spondyloarthritis

  This study tests whether a radiation-free 3D surface topography method can reflect spine damage and sagittal balance in adults with radiographic axial spondyloarthritis.

  Recruiting Ankara Etlik City Hospital · Ankara, Yenimahalle · NCT07855393

• MK-8644: first-in-human test in healthy people and people with psoriasis

  This early-phase study tests MK-8644 versus placebo in healthy volunteers and people with psoriasis to see if it is safe and tolerable.

  Recruiting Phase 1 Merck Sharp & Dohme LLC · Melbourne, Victoria · NCT07850310

• Is XJH05 Ointment Effective for Plaque Psoriasis?

  This study tests whether the XJH05 ointment can help people with plaque psoriasis compare to a calcipotriol ointment.

  Recruiting Xijing Hospital · Xi'an, Shaanxi · NCT07780929

• Guselkumab after Ustekinumab in adults with moderate-to-severe psoriasis in routine care

  This study looks at how well guselkumab works for people with moderate-to-severe psoriasis after switching from ustekinumab in everyday clinical practice.

  Recruiting Janssen-Cilag Kft. · Budapest · NCT07746583

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.