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

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT01228669

Collaborator

(none)

Enrollment

Locations

Arms

22.5

Actual Duration (Months)

3.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Congenital Bleeding Disorder Haemophilia A Haemophilia B Healthy	Drug: NNC 0172-0000-2021 Drug: NNC 0172-0000-2021 Drug: placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Multi-centre, Randomised, Double-blind, Placebo-controlled, Single Dose, Dose Escalation Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC 0172-0000-2021 Administered Intravenously and Subcutaneously to Healthy Male Subjects and Haemophilia Subjects

Actual Study Start Date :

Oct 25, 2010

Actual Primary Completion Date :

Sep 10, 2012

Actual Study Completion Date :

Sep 10, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A	Drug: NNC 0172-0000-2021 Single dose injected i.v. (into a vein). Each treatment dose is assessed for safety before escalating to next dose
Experimental: B	Drug: NNC 0172-0000-2021 Single dose injected s.c. (under the skin). Each treatment dose is assessed for safety before escalating to next dose.
Placebo Comparator: C	Drug: placebo Single dose injected i.v. and s.c. Each treatment dose is assessed for safety before escalating to next dose.

Arm

Intervention/Treatment

Experimental: A

Drug: NNC 0172-0000-2021

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

Experimental: B

Drug: NNC 0172-0000-2021

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

Placebo Comparator: C

Drug: placebo

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

Outcome Measures

Primary Outcome Measures

Number of adverse Events (AEs), including Serious Adverse Events (SAEs) [from trial product administration until 43 days after trial product administration]

Secondary Outcome Measures

Area under the concentration-time curve [from 43 days after trial product administration until 53 days after trial product administration]
Adverse Events (AEs), including Serious Adverse Events (SAEs) [from 43 days after trial product administration until 53 days after trial product administration]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Wien		Austria	1090
2	Novo Nordisk Investigational Site	København		Denmark	2100
3	Novo Nordisk Investigational Site	Berlin		Germany	10249
4	Novo Nordisk Investigational Site	Frankfurt/M.		Germany	60590
5	Novo Nordisk Investigational Site	Milano		Italy	20124
6	Novo Nordisk Investigational Site	Kuala Lumpur		Malaysia	50400
7	Novo Nordisk Investigational Site	Polokwane	Limpopo	South Africa	0699
8	Novo Nordisk Investigational Site	Madrid		Spain	28046
9	Novo Nordisk Investigational Site	Malmö		Sweden	205 02
10	Novo Nordisk Investigational Site	Zürich		Switzerland	8091
11	Novo Nordisk Investigational Site	Bangkok		Thailand	10400
12	Novo Nordisk Investigational Site	Harrow		United Kingdom	HA1 3UJ
13	Novo Nordisk Investigational Site	London		United Kingdom	NW3 2QG
14	Novo Nordisk Investigational Site	London		United Kingdom	SE1 7EH
15	Novo Nordisk Investigational Site	London		United Kingdom	W12 0NN
16	Novo Nordisk Investigational Site	Manchester		United Kingdom	M13 9WL