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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

2. november 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

90

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Kina
    • Zhejiang
      • Hangzhou, Zhejiang, Kina
        • Rekruttering
        • First People's Hospital of Hangzhou
        • Hovedetterforsker:
          • Ying Wang, PhD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 55 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: PART1: Group 1,75mg

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

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

Annen: HB0017 Placebo

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

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

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

Annen: HB0017 Placebo

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

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

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

Annen: HB0017 Placebo

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

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

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

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

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

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

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

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

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

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

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

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

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Adverse events
Tidsramme: through study completion

PART 1: Number of participants experiencing adverse events as assessed by CTCAE v5.0.
through study completion
Cmax
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
AUC
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: through study completion (approximately 140 days)

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Huabo Biopharm Co., Ltd.

Samarbeidspartnere

Shanghai Huaota Biopharmaceutical Co., Ltd.

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

19. januar 2026

Primær fullføring (Antatt)

31. desember 2026

Studiet fullført (Antatt)

28. februar 2027

Datoer for studieregistrering

Først innsendt

21. oktober 2026

Først innsendt som oppfylte QC-kriteriene

2. november 2026

Først lagt ut (Faktiske)

6. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

6. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • HB0017-HV-01-02
  • CTR20255233 (Annen identifikator: China Drug Clinical Trial Registry)

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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