NCT01228669|CompletedPhase 1

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

Explorer 1

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

Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

NN7415-38132010-020465-24U1111-1116-2356

Study Type

interventional

Target

Locations

11 countries

Sites

Timeline

RegisteredOct 2010

StartedOct 2010

CompletionSep 2012

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_1

Timeline

Completed

Started Oct 2010

Geographic Reach

11 countries

16 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.9 years study duration

First Submitted

Initial submission to the registry

October 25, 2010

Completed

Same day until next milestone

Study Start

First participant enrolled

October 25, 2010

Completed

1 day until next milestone

First Posted

Study publicly available on registry

October 26, 2010

Completed

1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2012

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2012

Completed

Last Updated

May 15, 2019

Status Verified

May 1, 2019

Enrollment Period

1.9 years

First QC Date

October 25, 2010

Last Update Submit

May 14, 2019

Conditions

Congenital Bleeding Disorder Haemophilia A Haemophilia B Healthy

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

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

Study Arms (3)

A

EXPERIMENTAL

Drug: NNC 0172-0000-2021

B

EXPERIMENTAL

Drug: NNC 0172-0000-2021

C

PLACEBO COMPARATOR

Drug: placebo

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

placeboDRUG

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

Eligibility Criteria

Age18 Years - 65 Years

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.