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A Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CITY-FXI in Healthy Adults, Adults With FV Leiden or Prothrombin G20210A Mutation, and Adults With a History of Provoked Venous Thromboembolism

23. september 2026 opdateret af: City Therapeutics

A Phase 1, Randomised, Double-Blind, Placebo-Controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CITY-FXI, a FXI Targeting siRNA, Administered Subcutaneously in Healthy Adults, Adults With Factor V Leiden or Prothrombin G20210A Mutation, and Adults With a History of Provoked Venous Thromboembolism

This is a first-in-human (FIH), single-center, randomized, double-blind, placebo-controlled, single ascending and multiple dose study evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of CITY-FXI in healthy adults, adults with Factor V Leiden (FVL) or prothrombin G20210A mutation, and adults with a history of provoked venous thromboembolism (VTE).

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The study will be conducted in three parts:

  • Part A: Single Ascending Dose in Healthy Adults
  • Part B: Single Ascending Dose in Adults with Factor V Leiden (FVL) or Prothrombin G20210A Mutation
  • Part C: Multiple Doses in Adults with FVL or Prothrombin G20210A Mutation and/or a History of Provoked Venous Thromboembolism (VTE)

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

182

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Males and women of non-childbearing potential (WONCBP) aged 18 to 45 years (inclusive, for Part A only)
  • Male and female participants aged 18 to 60 (inclusive, for Part B only), and aged 18 to 65 years (inclusive, for Part C only)
  • Body Mass Index (BMI) between 18 and 25 kg/m2 (inclusive, for Part B only) and 18 and 35 kg/m2 (inclusive, for Part C only) and a minimum weight of 50 kg (Parts A, B, and C)
  • Ability and willingness to comply fully with all study procedures and lifestyle considerations
  • Confirmed diagnosis of FVL or prothrombin G20210A mutation via genetic testing (Part B only)
  • Women of childbearing potential (WOCBP) must agree to use acceptable highly effective contraceptive methods (Parts B and C only)
  • History of provoked venous thromboembolism (VTE) within the last 10 years and/or confirmed diagnosis of heterozygosity for FVL and prothrombin G20210A mutation via genetic testing (Part C only)

Exclusion Criteria:

  • Any clinically significant systemic disease or disorder, including but not limited to cardiovascular, hepatic, or oncological conditions
  • History or evidence of any bleeding disorders
  • History of clinically significant spontaneous bleeding
  • Prior treatment with an investigational agent
  • Confirmed diagnosis of homozygous mutations, or combined thrombophilic defects (e.g., FVL with prothrombin G20210A mutation) (Parts B and C only)

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: Randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: CITY-FXI hos raske voksne (Del A)
Medicin: CITY-FXI

siRNA (subcutaneous injection)
Placebo komparator: I Raske Voksne (Del A)
Medicin: Placebo

Saline (subcutaneous injection)
Eksperimentel: CITY-FXI i voksne med Factor V Leiden eller Prothrombin G20210A-mutation (Del B)
Medicin: CITY-FXI

siRNA (subcutaneous injection)
Placebo komparator: I voksne med Factor V Leiden eller Prothrombin G20210A-mutation (Del B)
Medicin: Placebo

Saline (subcutaneous injection)
Eksperimentel: CITY-FXI in Adults with FVL, Prothrombin G20210A Mutation, and/or a History of Provoked VTE (Part C)
Medicin: CITY-FXI

siRNA (subcutaneous injection)
Placebo komparator: In Adults with FVL, Prothrombin G20210A Mutation, and/or a History of Provoked VTE (Part C)
Medicin: Placebo

Saline (subcutaneous injection)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence, severity, and relationship of treatment-emergent adverse events (TEAEs)
Tidsramme: Through study completion, up to Day 360

To evaluate the safety and tolerability of a single dose of CITY-FXI in healthy adults and adults with Factor V Leiden (FVL) or prothrombin G20210A mutation, and of a multiple dose regimen of CITY-FXI in adults with FVL or prothrombin G20210A mutation and/or a history of provoked VTE
Through study completion, up to Day 360

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Maximum plasma concentration (Cmax)
Tidsramme: Day 1 to Day 3 (Parts A and B); Days 1, 2, 91, 92 (Part C)

To characterize the pharmacokinetics (PK) of a single dose of CITY-FXI in healthy adults and adults with FVL or prothrombin G20210A mutation, and of a multiple dose regimen of CITY-FXI in adults with FVL or prothrombin G20210A mutation and/or a history of provoked VTE
Day 1 to Day 3 (Parts A and B); Days 1, 2, 91, 92 (Part C)
Area under plasma concentration time curve (AUC) of CITY-FXI
Tidsramme: Day 1 to Day 3 (Parts A and B); Days 1, 2, 91, 92 (Part C)

To characterize the pharmacokinetics (PK) of a single dose of CITY-FXI in healthy adults and adults with FVL or prothrombin G20210A mutation, and of a multiple dose regimen of CITY-FXI in adults with FVL or prothrombin G20210A mutation and/or a history of provoked VTE
Day 1 to Day 3 (Parts A and B); Days 1, 2, 91, 92 (Part C)
Amount excreted in urine (Ae) of CITY-FXI
Tidsramme: Day 1 to Day 3 (Parts A and B)

To characterize the pharmacokinetics (PK) of a single dose of CITY-FXI in healthy adults and adults with FVL or prothrombin G20210A mutation
Day 1 to Day 3 (Parts A and B)
Change from baseline in levels of plasma Factor XI (FXI)
Tidsramme: Up to Day 360

To characterize the pharmacodynamics (PD) of a single dose of CITY-FXI in healthy adults and adults with FVL or prothrombin G20210A mutation, and of a multiple dose regimen of CITY-FXI in adults with FVL or prothrombin G20210A mutation and/or a history of provoked VTE
Up to Day 360
Change from baseline of Factor XI (FXI) activity
Tidsramme: Up to Day 360

To characterize the pharmacodynamics (PD) of a single dose of CITY-FXI in healthy adults and adults with FVL or prothrombin G20210A mutation, and of a multiple dose regimen of CITY-FXI in adults with FVL or prothrombin G20210A mutation and/or a history of provoked VTE
Up to Day 360
Change from baseline in activated partial thromboplastin time (aPTT)
Tidsramme: Up to Day 360

To characterize the pharmacodynamics (PD) of a single dose of CITY-FXI in healthy adults and adults with FVL or prothrombin G20210A mutation, and of a multiple dose regimen of CITY-FXI in adults with FVL or prothrombin G20210A mutation and/or a history of provoked VTE
Up to Day 360

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

City Therapeutics

Efterforskere

  • Studieleder: Medical Director, City Therapeutics

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)

22. januar 2026

Primær færdiggørelse (Anslået)

1. marts 2028

Studieafslutning (Anslået)

1. april 2028

Datoer for studieregistrering

Først indsendt

9. januar 2026

Først indsendt, der opfyldte QC-kriterier

18. februar 2026

Først opslået (Faktiske)

24. februar 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • FXI-1101
  • C24027 (Anden identifikator: Richmond Pharmacology)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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