- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07600788
A Clinical Study Evaluating the Pharmacokinetic Characteristics and Safety of AHB-137 Injection in Participants With Mild to Moderate Liver Dysfunction and Those With Normal Liver Function.
14. maj 2026 opdateret af: Ausper Biopharma Co., Ltd.
A clinical study evaluating the pharmacokinetic characteristics and safety of AHB-137 injection in participants with mild to moderate liver dysfunction and those with normal liver function.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
32
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Lu
- Telefonnummer: 0571-86959519
- E-mail: clinicaltrial@ausperbio.com
Studiesteder
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, Kina
- Huashan Hospital Fudan University
-
Ledende efterforsker:
- Jing Zhang
-
Kontakt:
- Caihong Li
- Telefonnummer: 021-52888921
- E-mail: licaihong199505@163.com
-
Ledende efterforsker:
- Yuxian Huang
-
-
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
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
Inclusion Criteria:
- Voluntarily participate in the study, sign an informed consent form before the study and be able to complete the study according to the requirements of the protocol;
- At the time of signing the informed consent form, male or female participants aged 18-65 years (including threshold values);
- Body mass index meets the criteria;
- Take effective contraceptive measures as required;
- Participants with liver function impairment need to meet certain liver function assessments;
- Participants with normal liver function should meet certain age, weight, and gender requirements to match those with liver function impairment, and should also undergo certain physical and laboratory tests.
Exclusion Criteria:
- Diagnosed or suspected liver cancer participants who have undergone liver transplantation;
- History of vasculitis or presence of signs and symptoms of potential vasculitis or laboratory tests;
- Unstable control of hypertension or diabetes, progressive nervous system disease, history of immune related extrahepatic diseases, and unstable cardiac function;
- Participants with a history of malignant tumors or undergoing malignant tumor assessment;
- Screening for participants who have undergone significant trauma or surgery within the previous 3 months, as well as those who plan to undergo surgery;
- Participants with thyroid dysfunction who are not suitable for inclusion in the study;
- Allergic or allergic constitution to AHB-137;
- Long term regular receipt of anticoagulant or antiplatelet drugs is required;
- Those who have received any antisense oligonucleotide drugs or have been treated with siRNA drugs or interferon within the 12 months prior to screening;
- Currently using or using any immunosuppressive medication within the past 3 months prior to screening, except for short-term use or the use of topical/inhaled steroids; Individuals who have used immunomodulators and cytotoxic drugs within the 6 months prior to administration;
- Those who have a history of vaccination or a plan to receive live vaccines within one month before administration, those who have used creatine containing fitness supplements 14 days before administration, and those who have used albumin 14 days before administration;
- HIV, Syphilis positive ;
- Those who are participating in another clinical trial and have not been eluted as required;
- Positive results in urine drug screening and alcohol breath screening tests during screening;
- Those who drink excessively and consume prohibited foods and beverages before administration;
- Participants who have donated blood (or lost blood) ≥ 400 ml, received whole blood, or used red blood cell suspension within the past 3 months prior to screening; Individuals with a history of needle or blood dizziness, difficulty in blood collection, or intolerance to venipuncture blood collection;
- Long term regular vigorous exercise or intense exercise within 48 hours before screening;
- Any other circumstances or conditions that the researcher deems unsuitable for the subject to participate in this study;
- Diseases that need to be excluded according to the merger plan for patients with abnormal liver function;
- The laboratory test results do not meet the requirements of the protocol;
- Participants with normal liver function who have a history of chronic liver disease or known liver or biliary abnormalities;
- Participants with normal liver function who have used traditional Chinese medicine or other systemic medications with potential liver toxicity 14 days before administration;
- Participants with normal liver function and abnormal QTcF values.
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: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Part1: Child-Pugh B group
|
Single use subcutaneous injection
|
|
Eksperimentel: Part2: Child-Pugh A group
|
Single use subcutaneous injection
|
|
Eksperimentel: Part1:Participants with normal liver function group
|
Single use subcutaneous injection
|
|
Eksperimentel: Part2:Participants with normal liver function group
|
Single use subcutaneous injection
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Key PK parameters of AHB-137 injection after single subcutaneous administration: peak concentration (Cmax)
Tidsramme: Up to day 29
|
Up to day 29
|
|
Key PK parameters of AHB-137 injection after single subcutaneous administration: area under the drug time curve from 0 to infinity (AUC)
Tidsramme: Up to day 29
|
Up to day 29
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
PK parameter: Area under the drug time curve from 0 to the last endpoint quantifiable concentration time point (AUCo- Last)
Tidsramme: Up to day 29
|
Up to day 29
|
|
|
PK parameter: Area under the drug time curve from 0 to 24 hours (AUCo-24)
Tidsramme: Up to day 29
|
Up to day 29
|
|
|
PK parameter: Area under the drug time curve from 0 to 168 hours (AUCo-168)
Tidsramme: Up to day 29
|
Up to day 29
|
|
|
PK parameter: D8 blood concentration (C168)
Tidsramme: Up to day 29
|
Up to day 29
|
|
|
PK parameter: peak time (Tmax)
Tidsramme: Up to day29
|
Up to day29
|
|
|
Safety indicators
Tidsramme: Up to day 29
|
The proportion of participants who experienced all adverse events (TEAEs), serious adverse events (SAEs), and adverse events of particular concern (AESIs) during the treatment period after a single subcutaneous administration of AHB-137 injection; And laboratory tests, 12 lead ECG, and changes in vital signs compared to baseline.
|
Up to day 29
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Jing Zhang, Huashan Hospital
- Ledende efterforsker: Yuxian Huang, Huashan Hospital
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 (Anslået)
15. maj 2026
Primær færdiggørelse (Anslået)
15. maj 2028
Studieafslutning (Anslået)
15. maj 2028
Datoer for studieregistrering
Først indsendt
14. maj 2026
Først indsendt, der opfyldte QC-kriterier
14. maj 2026
Først opslået (Faktiske)
22. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
14. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Blodbårne infektioner
- Organisering af lungebetændelse
- Patologiske processer
- Kronisk sygdom
- Sygdomsegenskaber
- Sygdomme i immunsystemet
- Infektioner
- Virussygdomme
- Luftvejssygdomme
- Sygdomme i fordøjelsessystemet
- Lungesygdomme
- Bronchiale sygdomme
- Lungesygdomme, obstruktiv
- Leversygdomme
- Hepatitis, viral, menneskelig
- Overførbare sygdomme
- DNA-virusinfektioner
- Hepadnaviridae infektioner
- Hepatitis, kronisk
- Bronchiolitis Obliterans
- Bronchiolitis
- Bronkitis
- Hepatitis
- Graft vs værtssygdom
- Patologiske tilstande, tegn og symptomer
- Bronchiolitis Obliterans syndrom
- Hepatitis B
- Hepatitis B, kronisk
Andre undersøgelses-id-numre
- AB-10-8010
Plan for individuelle deltagerdata (IPD)
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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 .
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