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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 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

90

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 55 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: PART1: Group 1,75mg

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

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

Andet: HB0017 Placebo

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

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

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

Andet: HB0017 Placebo

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

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

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

Andet: HB0017 Placebo

pre-filled syringe,1 mL/per injection
Eksperimentel: 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
Eksperimentel: 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
Eksperimentel: 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
Eksperimentel: 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
Eksperimentel: 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
Eksperimentel: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Huabo Biopharm Co., Ltd.

Samarbejdspartnere

Shanghai Huaota Biopharmaceutical Co., Ltd.

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

19. januar 2026

Primær færdiggørelse (Anslået)

31. december 2026

Studieafslutning (Anslået)

28. februar 2027

Datoer for studieregistrering

Først indsendt

21. oktober 2026

Først indsendt, der opfyldte QC-kriterier

2. november 2026

Først opslået (Faktiske)

6. november 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

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