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 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.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Vaihe 1
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Ying Wang, PhD
- Puhelinnumero: 086-18367124548
- Sähköposti: nancywangying@163.com
Opiskelupaikat
-
-
Zhejiang
-
Hangzhou, Zhejiang, Kiina
- Rekrytointi
- First People's Hospital of Hangzhou
-
Päätutkija:
- Ying Wang, PhD
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Nelinkertaistaa
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: PART1: Group 1,75mg
single-dose, SC, HB0017 75 mg or placebo |
pre-filled syringe, 150 mg/(1 mL)/per injection pre-filled syringe,1 mL/per injection |
|
Kokeellinen: PART1: Group 2, 150mg
single-dose, SC, HB0017 150 mg or placebo |
pre-filled syringe, 150 mg/(1 mL)/per injection pre-filled syringe,1 mL/per injection |
|
Kokeellinen: PART1: Group 3, 300mg
single-dose, SC, HB0017 300 mg or placebo |
pre-filled syringe, 150 mg/(1 mL)/per injection pre-filled syringe,1 mL/per injection |
|
Kokeellinen: PART2: Group 4, 150mg, domen
single-dose, SC at domen, HB0017 150 mg |
pre-filled syringe, 150 mg/(1 mL)/per injection |
|
Kokeellinen: PART2: Group 5, 150mg, upper arms
single-dose, SC at upper arms, HB0017 150 mg |
pre-filled syringe, 150 mg/(1 mL)/per injection |
|
Kokeellinen: PART2: Group 6, 150mg, thihgs
single-dose, SC at thighs, HB0017 150 mg |
pre-filled syringe, 150 mg/(1 mL)/per injection |
|
Kokeellinen: PART2: Group 7, 300mg, domen
single-dose, SC at domen, HB0017 300 mg |
pre-filled syringe, 150 mg/(1 mL)/per injection |
|
Kokeellinen: PART2: Group 8, 300mg, upper arms
single-dose, SC at upper arms, HB0017 300 mg |
pre-filled syringe, 150 mg/(1 mL)/per injection |
|
Kokeellinen: PART2: Group 9, 300mg, thighs
single-dose, SC at thighs, HB0017 300 mg |
pre-filled syringe, 150 mg/(1 mL)/per injection |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Adverse events
Aikaikkuna: through study completion
|
PART 1: Number of participants experiencing adverse events as assessed by CTCAE v5.0. |
through study completion
|
|
Cmax
Aikaikkuna: 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
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
AUC
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: through study completion (approximately 140 days)
|
Number and percentage of participants with a positive neutralizing antibody (NAb) result. |
through study completion (approximately 140 days)
|
Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Päätutkija: Ying Wang, PhD, First People's Hospital of Hangzhou
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- HB0017-HV-01-02
- CTR20255233 (Muu tunniste: China Drug Clinical Trial Registry)
Lääke- ja laitetiedot, tutkimusasiakirjat
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