- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07748026
A Study of ART105 in Healthy Adult Participants
A Phase I, Randomized, Double-blind, Placebo-controlled, Dose-escalation Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Subcutaneous Injection of ART105 in Healthy Adult Participants
The goal of this clinical trial is to learn if ART105 is safe in healthy adult participants. It will also learn about the PK and PD profiles of ART105. The main questions it aims to answer are:
Is ART105 safe and tolerable in adult participants? How does the ART105 influence the urine PC1 level of participants?
Participants will:
recieve single dose of ART105 and visit the clinic 3 months
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 1
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Voluntary participation with signed written informed consent (ICF) .
- Male or female, aged 18-55 years (inclusive).
- males ≥ 50 kg; females ≥ 45 kg; and BMI between 19 and 26 kg/m² (inclusive).
- No history of clinically significant abnormalities.
- Normal or not clinically significant (NCS) findings at screening for vital signs, physical exam, lab tests, 12-lead ECG, and abdominal ultrasound.
- Participants of childbearing potential (or males with partners of childbearing potential) must agree to use highly effective contraception.
Exclusion Criteria:
- Any uncontrolled or severe disease, or any medical or surgical condition that may interfere with the participant's participation in the clinical trial
- History of hypersensitivity to oligonucleotide drugs, or known hypersensitivity to the investigational product or any of its excipients
- Use of any ASO or siRNA drugs within 12 months prior to the first dose
- History of alcohol abuse
- History of drug or substance abuse, or a positive urine drug abuse screening test
- Major surgery within 3 months prior to the administration of the investigational product or planned elective surgery during the study period.
- Use of any prescription medications, over-the-counter (OTC) drugs, or herbal medicines within 14 days prior to the administration of the investigational product, or within 5 half-lives of the drug (whichever is longer).
- Enrollment in or ongoing participation in any other clinical trial within 3 months or 5 half-lives (whichever is longer) prior to the administration of the investigational product
- Positive screening results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV), human immunodeficiency virus antibody (anti-HIV), or Treponema pallidum antibody (syphilis).
- Occurrence of acute illness or use of concomitant medications from the screening phase until prior to the administration of the investigational product.
- Consumption of any alcohol-containing products or a positive breath alcohol test within 48 hours prior to the administration of the investigational product.
- Participants who, in the investigator's opinion, have other factors that make them unsuitable for participation in this study.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: first dose level
ART105 OR Placebo
|
indsprøjtning
injection
|
|
Eksperimentel: second dose level
ART105 OR Placebo
|
indsprøjtning
injection
|
|
Eksperimentel: third dose level
ART105 OR Placebo
|
indsprøjtning
injection
|
|
Eksperimentel: fourth dose level
ART105 OR Placebo
|
indsprøjtning
injection
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of AEs
Tidsramme: Baseline to Day 85
|
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
|
Baseline to Day 85
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Plasma maximum observed concentration (Cmax) of ART105
Tidsramme: Baseline to Day 3
|
Baseline to Day 3
|
|
|
Plasma time to maximum observed concentration (Tmax) of ART105
Tidsramme: Baseline to Day 3
|
Baseline to Day 3
|
|
|
Plasma half-life (t½) of ART105
Tidsramme: Baseline to Day 3
|
Baseline to Day 3
|
|
|
Plasma area under the concentration-time curve up to 24 hr post dose (AUC0-24) of ART105
Tidsramme: Baseline to Day 3
|
Baseline to Day 3
|
|
|
Fraction of ART105 excreted in the urine (fe)
Tidsramme: Baseline to Day 3
|
Baseline to Day 3
|
|
|
Total amount of ART105 excreted in the urine (Ae)
Tidsramme: Baseline to Day 3
|
Baseline to Day 3
|
|
|
PD biomarkers change
Tidsramme: Baseline to Day 85
|
Changes from baseline in urine PC1 and PC2 levels
|
Baseline to Day 85
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Concentration of neutrophil gelatinase-associated lipocalin (NGAL) in urine
Tidsramme: Baseline to Day 29
|
Baseline to Day 29
|
|
|
Concentration of kidney injury molecule-1 (KIM-1) in urine
Tidsramme: Baseline to Day 29
|
Baseline to Day 29
|
|
|
Incidence of ADA
Tidsramme: Baseline to Day 85
|
Incidence of ADA with NAb testing for ADA-positive samples if necessary
|
Baseline to Day 85
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- ART105-CN-01
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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