- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03366688
Single Ascending Dose Study of PCSK-9 Inhibitor (IBI306) in Healthy Subjects.
17. december 2020 opdateret af: Innovent Biologics (Suzhou) Co. Ltd.
A Randomized, Double Blind, Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics/Pharmacodynamics of IBI306 in Healthy Subjects.
IBI306 is a fully human monoclonal antibody that binds proprotein convertase substilisin/kexin type 9 (PCSK9), preventing its interaction with the low-density lipoprotein cholesterol receptor (LDL-R) and thereby restoring LDL-R recycling and low-density lipoprotein cholesterol(LDL-C)uptake.
This is a randomized, double-blind, placebo-controlled,single ascending dose study to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics and immunogenicity of IBI306 in healthy adults.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Ascending dose design includes 6 dose levels (25 mg, 75 mg, 150 mg, 300 mg, 450 mg and 600 mg).
Tolerance and safety data up to 14 days after dosing from all subjects of the previous cohort will be reviewed before proceeding to the next dose.
Total duration of the study per subject is 12 weeks.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
58
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Beijing, Kina
- Peking University First Hospital
-
-
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:
- Chinese healthy men or women aged 18 to 55 years old at screening (inclusive);
- Serum LDL-C concentration between 1.8 mmol/L and 4.9 mmol/L (inclusive)at screening;
- Body mass index between 19 and 28 kg/m2 (inclusive);
- Willing to maintain the current regular diet and physical activity;
- Female subjects and male subject's partner who could become pregnant should take effective contraceptions during the treatment period and 6 months after dosing;
- Without any medical history of serious diseases;
- Willing to comply with protocol required visit schedule and visit requirements and provide written informed consent.
Exclusion Criteria:
- Breast-feeding or pregnant women;
- History of allergic reaction;
- Previously received any anti-PCSK-9 treatment;
- Vital signs, physical examination, clinical laboratory test, 12-lead ECG, and chest X-ray are abnormal with clinical significance;
- Not willing to stop intense physical activities (such as weight lifting or long-distance running) before 72 hours of the scheduled visits;
- Any hospitalization within one month before screening, or major surgery within six months before screening, or any other unstable medical condition;
- Received an investigational chemical agent within 30 days before dosing;
- Received an investigational biological agent within 90 days before dosing;
- Use of medications including over-the-counter medication within 14 days or less than 5 half-lifes of the agent;
- Use of herb,vitamins or nutraceutical in order to alter serum lipids;
- Positive screen of hepatitis B surface antigen, hepatitis C virus, human immunodeficiency virus or syphilis infection at screening;
- History or clinical evidence of alcohol or drugs of abuse within 12 months before screening;
- With any consumption of alcohol and caffeinated beverages within 72 hours prior to and during the trial;
- Blood donations or blood loss 200 ml and more within 2 months before screening;
- History of organ transplantation or malignant tumor;
- Any conditions which, in the opinion of the Investigator, would make the subject unsuitable for enrollment.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: IBI306
Subcutaneous or intravenous injection of a single dose of IBI306, dose level according to ascending dose design
|
Cohort 1: 25 mg Subcutaneous(SC) (this cohort is open label without placebo); Cohort 2: 75 mg SC; Cohort 3: 150 mg SC; Cohort 4: 75 mg IV; Cohort 5: 300 mg SC; Cohort 6: 450 mg SC; Cohort 7: 600 mg SC; Cohort 8: 450 mg IV.
|
|
Placebo komparator: placebo
Subcutaneous or intravenous injection of a single dose of placebo, dose level according to ascending dose design
|
Cohort 2: 75 mg SC; Cohort 3: 150 mg SC; Cohort 4: 75 mg IV; Cohort 5: 300 mg SC; Cohort 6: 450 mg SC; Cohort 7: 600 mg SC; Cohort 8: 450 mg IV.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Number of participants with adverse events(AEs) as assessed by the criteria of National Institute on Aging
Tidsramme: up to 12 weeks
|
up to 12 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
The area under the curve (AUC) of serum concentration of the drug after the administration
Tidsramme: up to 12 weeks
|
up to 12 weeks
|
|
Maximum concentration (Cmax) of the drug after the administration
Tidsramme: up to 12 weeks
|
up to 12 weeks
|
|
Time at which maximum concentration (Tmax) occurs for the drug after the administration
Tidsramme: up to 12 weeks
|
up to 12 weeks
|
|
The half-life (t1/2) of drug after the administration
Tidsramme: up to 12 weeks
|
up to 12 weeks
|
|
Assessment of serum concentrations of PCSK-9
Tidsramme: up to 12 weeks
|
up to 12 weeks
|
|
Change from baseline in lipid parameters
Tidsramme: up to 12 weeks
|
up to 12 weeks
|
|
Number of participants with anti-drug antibodies or neutralizing antibodies
Tidsramme: up to 12 weeks
|
up to 12 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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)
27. november 2017
Primær færdiggørelse (Faktiske)
5. november 2018
Studieafslutning (Faktiske)
5. november 2018
Datoer for studieregistrering
Først indsendt
27. november 2017
Først indsendt, der opfyldte QC-kriterier
6. december 2017
Først opslået (Faktiske)
8. december 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
21. december 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. december 2020
Sidst verificeret
1. december 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CIBI306A101
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Qualified researchers may request access to patient level data and related study documents including the study protocol with any amendments and statistical analysis plan.
Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants.
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med IBI306
-
Shenzhen People's HospitalRekrutteringLipidmetabolismeforstyrrelser | Familiær hyperkolesterolæmi - Homozygot | Proprotein Convertase Subtilisin/Kexin 9Kina
-
Innovent Biologics (Suzhou) Co. Ltd.RekrutteringIkke-familial hyperkolesterolæmi og blandet hyperlipidæmiKina
-
Innovent Biologics (Suzhou) Co. Ltd.Afsluttet
-
Innovent Biologics (Suzhou) Co. Ltd.AfsluttetHomozygot familiær hyperkolesterolæmiKina
-
Innovent Biologics (Suzhou) Co. Ltd.AfsluttetHyperkolesterolæmiKina
-
Innovent Biologics (Suzhou) Co. Ltd.AfsluttetSunde mandlige emnerKina
-
Innovent Biologics (Suzhou) Co. Ltd.Afsluttet
-
Innovent Biologics (Suzhou) Co. Ltd.Afsluttet