Safety of NNC 0172-0000-2021 in Healthy Male Subjects and Subjects With Haemophilia A or B (Explorer 1)

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Haemophilia B; Haemophilia A; Congenital Bleeding Disorder

Treatments: Drug: placebo; Drug: NNC 0172-0000-2021

Study type: Interventional

Funder types: Industry

Identifiers

NCT01228669

NN7415-3813

U1111-1116-2356 (Other Identifier)

2010-020465-24 (EudraCT Number)

Details and patient eligibility

About

This trial is conducted in Europe and Asia. The aim of this clinical trial is to investigate the safety, pharmacokinetics (how the trial drug is distributed in the body) and pharmacodynamics (physiological effects of the drug on the body) of NNC 0172-0000-2021 administered intravenously and subcutaneously to healthy male subjects and subjects with haemophilia A or B

Enrollment: 52 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Body weight between 50 and 100 kg, both inclusive
• Body mass index (BMI) between 18.0 kg/m2 and 25.0 kg/m2, both inclusive
• For haemophilia subjects only: Diagnosed with severe haemophilia A or B

Exclusion criteria

• Known or suspected hypersensitivity to trial product(s) or related products
• Surgery planned to occur during the trial
• Any major and/or orthopaedic surgery within 30 days prior to trial product administration

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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52 participants in 3 patient groups, including a placebo group

A

Experimental group

Treatment:

Drug: NNC 0172-0000-2021

Drug: NNC 0172-0000-2021

B

Experimental group

Treatment:

Drug: NNC 0172-0000-2021

Drug: NNC 0172-0000-2021

C

Placebo Comparator group

Treatment:

Drug: placebo