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Study of TU7710 in Warfarin Anti-coagulated Healthy Male Subjects

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ClinicalTrials.gov Identifier: NCT06025552
Recruitment Status : Recruiting
First Posted : September 6, 2023
Last Update Posted : September 11, 2023
Sponsor:
Information provided by (Responsible Party):
TiumBio Co., Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hemophilia A Hemophilia B Blood Coagulation Disorders Drug: TU7710 Drug: Normal saline Phase 1

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:

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.
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A First-in-Human (FIH), Randomized, Double-Blind, Placebo-controlled, Phase 1a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Activity of TU7710 Following Single, Ascending, Intravenous, Dose Administration in Warfarin Anti-coagulated Healthy Male Subjects
Actual Study Start Date : August 2, 2023
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : February 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arms and Interventions
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Arm Intervention/treatment
Experimental: TU7710
TU7710 of escalating 5 doses
 Drug: 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.
Placebo Comparator: Normal Saline (placebo of TU7710)
Placebo of TU7710 at corresponding TU7710 dose level
 Drug: Normal saline
Placebo of TU7710 at corresponding TU7710 dose level. In each dose level, 2 subjects will be assigned to placebo group.


Outcome Measures
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Primary Outcome Measures :
  1. Number and proportion of participants with adverse events [ Time Frame: 30 days post-dose ]
    Number and proportion of participants with adverse events/ adverse reaction /SAE overall and by treatment group

  2. Number of subjects with significant abnormal laboratory values [ Time Frame: 30 days post-dose ]
    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.

  3. ADA and Neutralizing antibody results [ Time Frame: 30 days post-dose ]
    Incidence of subjects with ADA and Nab positive results

  4. Number of subjects with significant abnormal Electrocardiography (ECG) findings [ Time Frame: 30 days post-dose ]
    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.

  5. Number of subjects With Significant Abnormal vital sign findings [ Time Frame: 30 days post-dose ]
    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.


Secondary Outcome Measures :
  1. Pharmacokinetics assessment_Maximum concentration [ Time Frame: 4 days post-dose ]
    Maximum plasma VIIa activity level in each dose level

  2. Pharmacokinetics assessment_AUC last [ Time Frame: 4 days post-dose ]
    Area under plasma activity-time curve after TU7710 single administration from time zero to last quantifiable concentration

  3. Pharmacokinetics assessment_AUC inf [ Time Frame: 4 days post-dose ]
    Area Under the Plasma activity-time curve after TU7710 single administration From Time Zero Extrapolated to Infinity

  4. Pharmacokinetics assessment_Clearance [ Time Frame: 4 days post-dose ]
    Clearance after TU7710 single administration

  5. Pharmacokinetics assessment_Volume of distribution [ Time Frame: 4 days post-dose ]
    Volume of distribution after TU7710 single administration

  6. Pharmacokinetics assessment_Dose proportionality [ Time Frame: 4 days post-dose ]
    Regression analysis using the power model between the log-converted Cmax, AUClast, and the log-converted dose can be performed, and each parameter adjusted by dose can be calculated and compared between the dose groups

  7. Pharmacokinetics assessment_Tmax [ Time Frame: 4 days post-dose ]
    Time from administration to maximum plasma VIIa level in each dose level

  8. Pharmacodynamic assessment_INR change from baseline [ Time Frame: 5 days post-dose ]
    INR measurement change from baseline to day 5 in each treatment group and dose level

  9. Pharmacodynamic assessment_PT change from baseline [ Time Frame: 5 days post-dose ]
    PT measurement change from baseline to day 5 in each treatment group and dose level

  10. Pharmacodynamic assessment_aPTT change from baseline [ Time Frame: 5 days post-dose ]
    aPTT measurement change from baseline to day 5 in each treatment group and dose level

  11. Pharmacokinetics assessment_incremental recovery [ Time Frame: 4 days post-dose ]
    Incremental recovery after TU7710 single administration expressed as the ratio of measured peak level against dose per bodyweight


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06025552


Contacts
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Contact: Heeyeon Jung 031-600-1500 ext 1513 tiumbio@tiumbio.com

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Principal Investigator: Kyung Sang Yoo, M.D, Ph.D         
Sponsors and Collaborators
TiumBio Co., Ltd.
More Information
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Responsible Party: TiumBio Co., Ltd.
ClinicalTrials.gov Identifier: NCT06025552    
Other Study ID Numbers: TUB4PI-01
First Posted: September 6, 2023    Key Record Dates
Last Update Posted: September 11, 2023
Last Verified: August 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemostatic Disorders
Hemophilia A
Hemophilia B
Blood Coagulation Disorders
Blood Coagulation Disorders, Inherited
Hematologic Diseases
 Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Vascular Diseases
Cardiovascular Diseases