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

Novo Nordisk A/S52 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Congenital Bleeding Disorder Haemophilia A Haemophilia B Healthy

Interventions

NNC 0172-0000-2021DRUG

Single dose injected i.v. (into a vein). Each treatment dose is assessed for safety before escalating to next dose

NNC 0172-0000-2021DRUG

Single dose injected s.c. (under the skin). Each treatment dose is assessed for safety before escalating to next dose.

placeboDRUG

Single dose injected i.v. and s.c. Each treatment dose is assessed for safety before escalating to next dose.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (16)

Novo Nordisk Investigational Site

Vienna, Austria

Novo Nordisk Investigational Site

Copenhagen, Denmark

Novo Nordisk Investigational Site

Outcomes

Primary Outcomes

Number of adverse Events (AEs), including Serious Adverse Events (SAEs)

Time frame: from trial product administration until 43 days after trial product administration

Secondary Outcomes

Area under the concentration-time curve

Time frame: from 43 days after trial product administration until 53 days after trial product administration

Adverse Events (AEs), including Serious Adverse Events (SAEs)

Time frame: from 43 days after trial product administration until 53 days after trial product administration

Data from ClinicalTrials.gov

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