Study of TU7710 in Warfarin Anti-coagulated Healthy Male Subjects

NCT06025552 | Completed Phase 1

• 1 other identifier: TUB4PI-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemophilia a; Hemophilia B; Blood Coagulation Disorders

Outcome Measures

Primary Outcomes (5)

• Number and proportion of participants with adverse events

  Number and proportion of participants with adverse events/ adverse reaction /SAE overall and by treatment group

  30 days post-dose

• Number of subjects with significant abnormal laboratory values

  Mean with standard deviation, median, maximum, minimum results of laboratory values in each treatment group. The laboratory parameters that will be assessed are clinical chemistry, hematology and urinalysis.

  30 days post-dose

• ADA and Neutralizing antibody results

  Incidence of subjects with ADA and Nab positive results

  30 days post-dose

• Number of subjects with significant abnormal Electrocardiography (ECG) findings

  Mean with standard deviation, median, maximum, minimum results of ECG results in each treatment group. The ECG parameters that will be assessed are heart rate, PR interval, QRS interval, QT interval, and QTcF interval.

  30 days post-dose

• Number of subjects With Significant Abnormal vital sign findings

  Mean with standard deviation, median, maximum, minimum results of vital sign values in each treatment group. The vital signs that will be assessed are body temperature, pulse rate, respiratory rate, and systolic and diastolic blood pressure.

  30 days post-dose

Secondary Outcomes (11)

• Pharmacokinetics assessment_Maximum concentration

  4 days post-dose

• Pharmacokinetics assessment_AUC last

  4 days post-dose

• Pharmacokinetics assessment_AUC inf

  4 days post-dose

• Pharmacokinetics assessment_Clearance

  4 days post-dose

• Pharmacokinetics assessment_Volume of distribution

  4 days post-dose

Study Arms (2)

TU7710

EXPERIMENTAL

TU7710 of escalating 5 doses

Drug: TU7710

Normal Saline (placebo of TU7710)

PLACEBO COMPARATOR

Placebo of TU7710 at corresponding TU7710 dose level

Drug: Normal saline

Interventions

TU7710 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.

TU7710

Normal saline DRUG

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

Normal Saline (placebo of TU7710)

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• TiumBio Co., Ltd.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Hemophilia A; Hemophilia B; Blood Coagulation Disorders

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, X-Linked

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 5 cohorts with 5 dose levels will sequentially be escalated after safety review. 8 subjects in each cohort who will be randomly assigned to placebo or TU7710 group in 2:6 ratio.

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: September 6, 2023
• Study Start: August 2, 2023
• Primary Completion: August 21, 2024
• Study Completion: August 21, 2024
• Last Updated: September 27, 2024

Record last verified: 2024-09

Locations

KR (1)