NCT06025552

Study of TU7710 in Warfarin Anti-coagulated Healthy Male Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: TiumBio Co., Ltd. · Industry
• Sex: Male
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.
DRUG	Normal saline	Placebo of TU7710 at corresponding TU7710 dose level. In each dose level, 2 subjects will be assigned to placebo group.

Timeline

• Start date: 2023-08-02
• Primary completion: 2024-08-21
• Completion: 2024-08-21
• First posted: 2023-09-06
• Last updated: 2024-09-27

Locations

1 site across 1 country: South Korea