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

ThromboGenics

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: TB-402; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00612196

TB-402-001

Details and patient eligibility

About

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

Enrollment: 56 patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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%.

Trial design

56 participants in 10 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: TB-402

2

Experimental group

Treatment:

Drug: TB-402

3

Experimental group

Treatment:

Drug: TB-402

4

Experimental group

Treatment:

Drug: TB-402

5

Experimental group

Treatment:

Drug: TB-402

6

Experimental group

Treatment:

Drug: TB-402

7

Experimental group

Treatment:

Drug: TB-402

8

Experimental group

Treatment:

Drug: TB-402

9

Experimental group

Treatment:

Drug: TB-402

10

Placebo Comparator group

Treatment:

Drug: Placebo