Study of TU7710 in Warfarin Anti-coagulated Healthy Male Subjects

Tiumbio

Status and phase: Completed; Phase 1

Conditions: Hemophilia B; Hemophilia a; Blood Coagulation Disorders

Treatments: Drug: TU7710; Drug: Normal saline

Study type: Interventional

Funder types: Industry

Identifiers

NCT06025552

TUB4PI-01

Details and patient eligibility

About

This is a Phase 1a, double-blind, randomized, placebo- controlled, SAD study to assess safety, tolerability, PK, and PD of TU7710 in warfarin treated healthy male participants.

Full description

The 40 subjects will be divided into 5 cohorts, and the subjects assigned to each cohort will be randomly assigned with 6 persons receiving TU7710 and 2 persons receiving a placebo for TU7710. Each cohort will proceed in sequence and the next cohort study will be decided by the Safety Monitoring Committee (SMC) .

Subjects will be participated in the study after warfarin anti-coagulation to maintain the INR between 2.00 and 3.00 as a preventive measure for potential thrombosis prior to the IP administration.

Enrollment: 40 patients

Sex: Male

Ages: 19 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age ≥19 and ≤45
• BMI of ≥18.0 kg/m2 and ≤30.0 kg/m2
• Body weight of ≥55.0 kg and ≤90.0 kg
• Provide informed consent and willing to comply with study requirements.

Exclusion criteria

• History or at risk of developing diseases related to venous thromboembolic events or has family history of such disease
• History of major bleeding/traumatic event or major surgery within 6 month
• History of any other clinically relevant coagulation disorder (such as gastrointestinal bleeding, hemorrhoid hemorrhage)
• Abnormal coagulation related laboratory abnormal test results, including protein C, protein S, PT, aPTT
• history or current symptoms of gastrointestinal, liver, or renal disease that may affect the pharmacokinetics of the IP
• History of or are currently with hepatitis B or C (active or carrier state) or human immunodeficiency virus (HIV) or syphilis infection.
• Currently smoking or have smoked within 1 month before IP or positive cotinine results
• History of alcohol abuse or positive alcohol breath test
• Excessive caffeine intake within 7 days before IP
• INR results not between 2.0~3.0 range after warfarin treatment
• History of hypersensitivity to medicinal product similar to TU7710 active ingredient or excipient
• Laboratory abnormal test results, such as QTcF <340msec or >450msec (or family history of long QT syndrome), LDL >190mg/dl , Total cholesterol >300mg/dl, triglycerides > 350mg/dl, ALT >1.5*ULN, AST >1.5*ULN, bilirubin >1.5*ULN
• Abnormal vital sign SBP >140mmHG, DBP <90mmHg, heart rate <40bpm or >85bpm
• Any medical history that may increase the risk or affect the evaluation of study objectives by participating in this study at the discretion of the investigator. (e.g., neurology or psychiatric history)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

TU7710

Experimental group

Description:

TU7710 of escalating 5 doses

Treatment:

Drug: TU7710

Normal Saline (placebo of TU7710)

Placebo Comparator group

Description:

Placebo of TU7710 at corresponding TU7710 dose level

Treatment:

Drug: Normal saline