A Phase I Study of Monoclonal Antibody TB-402 in Healthy Male Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2007-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Dose escalation study to assess the safety and tolerability of TB-402, a monoclonal antibody directed against FVIII, versus placebo in healthy male volunteers.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Use of Direct Oral Anticoagulants (DOACs) in Patients With Ph-negative Myeloproliferative Neoplasms

NCT04192916

Myeloproliferative Neoplasm

COMPLETED

Role of Monocytes Sub-populations in Thrombosis Associated With Myeloproliferative Neoplasms (MonSThr)

NCT05419648

Myeloproliferative Neoplasm

COMPLETED

Pathogen Reduction Evaluation & Predictive Analytical Rating Score

NCT02783313

Thrombocytopenia

COMPLETED NA

Evaluating the Safety of Long Term Dosing of Romiplostim (Formerly AMG 531) in Thrombocytopenic Subjects With Myelodysplastic Syndromes (MDS)

NCT00472290

Hematology MDS Myelodysplastic Syndromes +1 more

COMPLETED NA

Study to Reveal if Fibrinogen Treatment Effects Blood Clotting Better Than a Platelet Transfusion

NCT01955811

Blood Platelet Transfusion Blood Clotting

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

TB-402

Intervention Type DRUG

Solution for infusion, 0.015ug/kg-1.8mg/kg, single dose, iv infusion over 30 minutes

2

Group Type EXPERIMENTAL

TB-402

Intervention Type DRUG

Solution for infusion, 0.015ug/kg-1.8mg/kg, single dose, iv infusion over 30 minutes

3

Group Type EXPERIMENTAL

TB-402

Intervention Type DRUG

Solution for infusion, 0.015ug/kg-1.8mg/kg, single dose, iv infusion over 30 minutes

4

Group Type EXPERIMENTAL

TB-402

Intervention Type DRUG

Solution for infusion, 0.015ug/kg-1.8mg/kg, single dose, iv infusion over 30 minutes

5

Group Type EXPERIMENTAL

TB-402

Intervention Type DRUG

Solution for infusion, 0.015ug/kg-1.8mg/kg, single dose, iv infusion over 30 minutes

6

Group Type EXPERIMENTAL

TB-402

Intervention Type DRUG

Solution for infusion, 0.015ug/kg-1.8mg/kg, single dose, iv infusion over 30 minutes

7

Group Type EXPERIMENTAL

TB-402

Intervention Type DRUG

Solution for infusion, 0.015ug/kg-1.8mg/kg, single dose, iv infusion over 30 minutes

8

Group Type EXPERIMENTAL

TB-402

Intervention Type DRUG

Solution for infusion, 0.015ug/kg-1.8mg/kg, single dose, iv infusion over 30 minutes

9

Group Type EXPERIMENTAL

TB-402

Intervention Type DRUG

Solution for infusion, 0.015ug/kg-1.8mg/kg, single dose, iv infusion over 30 minutes

10

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TB-402

Solution for infusion, 0.015ug/kg-1.8mg/kg, single dose, iv infusion over 30 minutes

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Males 18 to 45 (Groups 1-9) or 55 to 75 (Group 10) years of age
* No clinically important abnormal physical, laboratory, ECG findings
* Normal (or abnormal but ncs) supine blood pressure (BP) and heart rate (HR)

Exclusion Criteria

* Self or family history of cardiovascular or pulmonary disorder, coagulation or bleeding disorders or reasonable suspicion of vascular malformations eg cerebral haemorrhage, aneurysm or premature stroke.
* Any autoimmune disease.
* Previous allergic reaction to immunoglobulin.
* Present, or history of, severe allergy, for example asthma or anaphylactic reactions or allergy requiring treatment.
* Consumption of aspirin, other non-steroidal anti-inflammatory drugs or other drugs known to affect platelet function or any other aspect of coagulation within 14 days before drug administration.
* Abnormal platelet function or clinically significant out of range values for any coagulation tests.
* History of important bleeding episodes eg haematemesis, rectal bleeding, severe or recurrent epistaxis, haemoptysis, haematuria or intracranial haemorrhage.
* Screening FVIII:C \< 50%.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes