Phase 1 clinical trial of hemocoagulase

A Dose Block-Randomized, Double-Blinded, Placebo-Controlled, Single-Dosing, Dose Escalation Phase I Clinical Trial to Evaluate Tolerability, Safety and Pharmacodynamics of BB-rB1 (recombinant batroxobin) in Healthy Volunteers

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0002518

Enrollment

Registered

2017-11-03

Start date

2014-10-13

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Cohort 1: 2.5 BU/2.0 mL (n=8

Placebo=2, BB-rB1=6) Cohort 2: 5.0 BU/2.0 mL (n=8

Placebo=2, BB-rB1=6) Cohort 3: 10.0 BU/2.0 mL (n=8

Placebo=2, BB-rB1=6) This is a randomized, double-blind, placebo-controlled, single ascending dose, and parallel design study. The subjects are enrolled in one of three cohorts (2.5, 5.0, and 10.0 b

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Body mass index between 18.5 and 25 kg/m2 2) Person who received sufficient explanation about the trial, understood and made a voluntary decision to participate and to comply with the precautions in the study by signing the written informed consent form

Exclusion criteria

Exclusion criteria: 1) AST or ALT > UNL x 1.5 or Total bilirubin > UNL x 1.5 2) Persons with hisotry of disease (cardiovasuclar system, respiratory, renal, endocrine, gastrointestinal system, central nervous system, mental diseases or hemato-oncology) that can affect pharmacodynamics of test drug 3) Persons having clinically significant hypersensitivity after skin test of BB-rB1

Design outcomes

Primary

Measure	Time frame
adverse events;PT (Prothrombin time);aPTT (activated partial thromboplastin time);TT (thrombin time);Fibrinogen	—

Countries

Korea, Republic of

Contacts

Public ContactYoung Seomun

BioBud

youngsm@nc-bit.com+82-31-628-0800

Outcome results