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

ConditionsFactor V LeidenProthrombin G20210A
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorCity Therapeutics

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Males and women of non-childbearing potential (WONCBP) aged 18 to 45 years (Part A only)

Male and female participants aged 18 to 60 (Part B only)

Body Mass Index (BMI) between 18 and 25 kg/m2 (inclusive) and a minimum weight of 50 kg

Ability and willingness to comply fully with all study procedures and lifestyle considerations

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • CITY-FXI

    Drug

    siRNA (subcutaneous injection)

  • Placebo

    Drug

    Saline (subcutaneous injection)

Treatment groups

128 Participants
are divided into 4 treatment groups
Group A: CITY-FXI in Healthy Adults (Part A)Experimental treatment 1 intervention
Group B: In Healthy Adults (Part A)Placebo comparator 1 intervention
Group C: CITY-FXI in Adults with Factor V Leiden or Prothrombin G20210A Mutation (Part B)Experimental treatment 1 intervention
Group D: In Adults with Factor V Leiden or Prothrombin G20210A Mutation (Part B)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence, severity, and relationship of treatment-emergent adverse events (TEAEs)

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

Time frame
Through study completion, up to Day 360

Secondary outcomes

1

Maximum plasma concentration (Cmax)

To characterize the pharmacokinetics (PK) of a single dose of CITY-FXI in healthy adults and adults with FVL or prothrombin G20210A mutation

Time frame
Day -1 to Day 3
2

Area under plasma concentration time curve (AUC) of CITY-FXI

To characterize the pharmacokinetics (PK) of a single dose of CITY-FXI in healthy adults and adults with FVL or prothrombin G20210A mutation

Time frame
Day -1 to Day 3
3

Amount excreted in urine (Ae) of CITY-FXI

To characterize the pharmacokinetics (PK) of a single dose of CITY-FXI in healthy adults and adults with FVL or prothrombin G20210A mutation

Time frame
Day -1 to Day 3
4

Change from baseline in levels of plasma Factor XI (FXI)

To characterize the pharmacodynamics (PD) of a single dose of CITY-FXI in healthy adults and adults with FVL or prothrombin G20210A mutation

Time frame
Up to Day 360

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

City Therapeutics

Lead sponsor

Source ClinicalTrials.gov
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