Study of TU7710 in Warfarin Anti-coagulated Healthy Male Subjects

NCT ID: NCT06025552

Last Updated: 2024-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-02
• Study Completion Date: 2024-08-21

Brief Summary

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.

Detailed 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.

Conditions

Hemophilia a; Hemophilia B; Blood Coagulation Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

TU7710

TU7710 of escalating 5 doses

Group Type: EXPERIMENTAL

TU7710

Intervention Type: DRUG

In each dose level, 6 subjects will be assigned to TU7710. Anticipated escalating dose levels are 100mcg/kg, 200mcg/kg, 400mcg/kg, 800mcg/kg and the last dose will be decided after assessing cohort 1\~4 PK, PD, safety, and exploratory efficacy data.

Normal Saline (placebo of TU7710)

Placebo of TU7710 at corresponding TU7710 dose level

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

Placebo of TU7710 at corresponding TU7710 dose level. In each dose level, 2 subjects will be assigned to placebo group.

Interventions

TU7710

In each dose level, 6 subjects will be assigned to TU7710. Anticipated escalating dose levels are 100mcg/kg, 200mcg/kg, 400mcg/kg, 800mcg/kg and the last dose will be decided after assessing cohort 1\~4 PK, PD, safety, and exploratory efficacy data.

Intervention Type: DRUG

Normal saline

Placebo of TU7710 at corresponding TU7710 dose level. In each dose level, 2 subjects will be assigned to placebo group.

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

TiumBio Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

TUB4PI-01

Identifier Type: -

Identifier Source: org_study_id