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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Fase 1
Contacten en locaties
Studiecontact
- Naam: Ying Wang, PhD
- Telefoonnummer: 086-18367124548
- E-mail: nancywangying@163.com
Studie Locaties
-
-
Zhejiang
-
Hangzhou, Zhejiang, China
- Werving
- First People's Hospital of Hangzhou
-
Hoofdonderzoeker:
- Ying Wang, PhD
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verviervoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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 |
|
Experimenteel: 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 |
|
Experimenteel: 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 |
|
Experimenteel: PART2: Group 4, 150mg, domen
single-dose, SC at domen, HB0017 150 mg |
pre-filled syringe, 150 mg/(1 mL)/per injection |
|
Experimenteel: PART2: Group 5, 150mg, upper arms
single-dose, SC at upper arms, HB0017 150 mg |
pre-filled syringe, 150 mg/(1 mL)/per injection |
|
Experimenteel: PART2: Group 6, 150mg, thihgs
single-dose, SC at thighs, HB0017 150 mg |
pre-filled syringe, 150 mg/(1 mL)/per injection |
|
Experimenteel: PART2: Group 7, 300mg, domen
single-dose, SC at domen, HB0017 300 mg |
pre-filled syringe, 150 mg/(1 mL)/per injection |
|
Experimenteel: PART2: Group 8, 300mg, upper arms
single-dose, SC at upper arms, HB0017 300 mg |
pre-filled syringe, 150 mg/(1 mL)/per injection |
|
Experimenteel: PART2: Group 9, 300mg, thighs
single-dose, SC at thighs, HB0017 300 mg |
pre-filled syringe, 150 mg/(1 mL)/per injection |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Adverse events
Tijdsspanne: through study completion
|
PART 1: Number of participants experiencing adverse events as assessed by CTCAE v5.0. |
through study completion
|
|
Cmax
Tijdsspanne: 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
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
AUC
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: through study completion (approximately 140 days)
|
Number and percentage of participants with a positive neutralizing antibody (NAb) result. |
through study completion (approximately 140 days)
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Ying Wang, PhD, First People's Hospital of Hangzhou
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- HB0017-HV-01-02
- CTR20255233 (Andere identificatie: China Drug Clinical Trial Registry)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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