- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07609875
A Phase I Single and Multiple Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of HS-10522 in Healthy Chinese Participants and Chinese Participants With Mild Hypertension
19. mai 2026 oppdatert av: Jiangsu Hansoh Pharmaceutical Co., Ltd.
A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Oral Doses of HS-10522 Tablets in Healthy Chinese Participants and Chinese Participants With Mild Hypertension
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of ascending single and multiple oral doses of HS-10522 in healthy Chinese participants and Chinese participants with mild hypertension.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
88
Fase
- Fase 1
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Ja
Beskrivelse
Inclusion Criteria:
-
For all participants:
- Able to understand the procedures and methods of the study, willing to strictly adhere to the clinical trial protocol to complete the study, and voluntarily sign the Informed Consent Form (ICF).
- Male or female participants aged 18 to 55 years (inclusive) at the time of signing ICF.
- At screening, body weight ≥ 50 kg for males and ≥ 45 kg for females, with a body mass index (BMI) between 19.0 and 28.0 kg/m² (inclusive).
Exclusion Criteria:
- Abnormal vital signs, physical examination findings, or laboratory test results at screening that are deemed clinically significant by the investigator.
- Presence of orthostatic hypotension or orthostatic tachycardia at screening.
- Clinically significant abnormal findings on the 12-lead ECG at screening, as judged by the investigator.
- Use of any medication within 2 weeks or 5 half-lives (whichever is longer) prior to screening, or anticipation of needing such medication during the trial.
- Known secondary causes of hypertension, or diseases that may affect adrenal function (e.g., renal artery stenosis, poorly controlled or untreated hyperthyroidism, poorly controlled or untreated hypothyroidism, hyperparathyroidism, pheochromocytoma, Cushing's syndrome).
- Participation in any other clinical trial of a drug or medical device within 12 weeks prior to screening, with receipt of at least one dose (including placebo), or currently within 5 half-lives of the last dose of the investigational product (whichever is longer).
- Participants who, in the opinion of the investigator, are likely to be non-compliant or are unsuitable for participation in this trial for any other reason.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: HS-10522
|
HS-10522 tablet, oral, single ascending dose and multiple ascending dose, once daily
|
|
Placebo komparator: HS-10522 Placebo
|
HS-10522 placebo , oral, single ascending dose and multiple ascending dose, once daily
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of adverse events following single and multiple doses of HS-10522 in healthy participants and participants with mild hypertension
Tidsramme: SAD: 0 to 7 days after dosing; MAD: 0 to 14 days after dosing
|
Safety and tolerability will be assessed by comparison of number of adverse events between groups
|
SAD: 0 to 7 days after dosing; MAD: 0 to 14 days after dosing
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Maximum plasma concentration (Cmax)
Tidsramme: -0.5 to 120 hour after dosing
|
-0.5 to 120 hour after dosing
|
|
|
time to maximum plasma concentration (Tmax)
Tidsramme: -0.5 to 120 hour after dosing
|
-0.5 to 120 hour after dosing
|
|
|
area under the curve (AUC)
Tidsramme: -0.5 to 120 hour after dosing
|
-0.5 to 120 hour after dosing
|
|
|
half-life
Tidsramme: -0.5 to 120 hour after dosing
|
-0.5 to 120 hour after dosing
|
|
|
apparent volume of distribution (Vz/F)
Tidsramme: -0.5 to 120 hour after dosing
|
-0.5 to 120 hour after dosing
|
|
|
apparent oral clearance (CL/F) of HS-10522
Tidsramme: -0.5 to 120 hour after dosing
|
-0.5 to 120 hour after dosing
|
|
|
Plasma aldosterone following single and multiple oral doses of HS-10522
Tidsramme: 0 to 96 hour after dosing
|
0 to 96 hour after dosing
|
|
|
Cortisol following single and multiple oral doses of HS-10522
Tidsramme: 0 to 96 hour after dosing
|
0 to 96 hour after dosing
|
|
|
Metabolites levels following single and multiple oral doses of HS-10522
Tidsramme: 0 to 96 hour after dosing
|
0 to 96 hour after dosing
|
|
|
(Exploratory) Mean seated systolic and diastolic blood pressure change compared with baseline
Tidsramme: 14 days after dosing
|
Blood pressure measurement will be performed only in MAD part
|
14 days after dosing
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. juni 2026
Primær fullføring (Antatt)
20. januar 2027
Studiet fullført (Antatt)
3. februar 2027
Datoer for studieregistrering
Først innsendt
11. mai 2026
Først innsendt som oppfylte QC-kriteriene
19. mai 2026
Først lagt ut (Faktiske)
27. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
27. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- HS-10522-101
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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