NCT02490787|CompletedPhase 1

Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of Concizumab Administered Subcutaneously to Haemophilia A Subjects

A Multi-centre, Randomised, Placebo Controlled, Double Blinded, Multiple Dose Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of Concizumab Administered Subcutaneously to Haemophilia A Subjects (Explorer™3)

Novo Nordisk A/S ClinicalTrials.gov

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4 other identifiers

NN7415-41592014-003793-16U1111-1161-1501NL53826.018.15

Study Type

interventional

Target

Locations

14 countries

Sites

Timeline

RegisteredJul 2015

StartedSep 2015

CompletionOct 2016

Brief Summary

This trial is conducted globally. The aim of this trial is to investigate safety, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of concizumab administered subcutaneously to haemophilia A subjects.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P25-P50 for phase_1

Timeline

Completed

Started Sep 2015

Geographic Reach

14 countries

32 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

1.1 years study duration

First Submitted

Initial submission to the registry

July 2, 2015

Completed

5 days until next milestone

First Posted

Study publicly available on registry

July 7, 2015

Completed

2 months until next milestone

Study Start

First participant enrolled

September 10, 2015

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2016

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2016

Completed

Last Updated

July 21, 2017

Status Verified

July 1, 2017

Enrollment Period

1.1 years

First QC Date

July 2, 2015

Last Update Submit

July 20, 2017

Conditions

Congenital Bleeding Disorder Haemophilia A

Outcome Measures

Primary Outcomes (1)

Number of adverse events (AEs)
From first trial drug administration (day 1) to 11 weeks after the first trial product administration

Secondary Outcomes (2)

Trough level of concizumab
Prior to the last s.c. dose administration (day 42)
Frequency of binding non-neutralizing anti-concizumab antibodies
From first trial drug administration (day 1) to 11 weeks after the first trial product administration

Study Arms (2)

Concizumab

EXPERIMENTAL

Drug: ConcizumabDrug: placebo

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

ConcizumabDRUG

Administered subcutaneously (s.c., under the skin) at five different dose levels (ranging from 0.25 to 1.5 mg/kg)

Concizumab

placeboDRUG

Administered subcutaneously (s.c., under the skin)

ConcizumabPlacebo

Eligibility Criteria

Age18 Years - 64 Years

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

Male subjects diagnosed with haemophilia A without inhibitors present at screening and currently treated on-demand
Subjects with a baseline level of factor VIII below or equal to 2 % based on medical records
Age between 18 and 64 years both inclusive, at the time of signing informed consent
Body weight between 50 and 100 kg, both inclusive

You may not qualify if:

Known or suspected hypersensitivity to trial product or related products
Platelet count below 50x10\^9/L at screening
Any clinical signs or known history of thromboembolic events, or subjects considered at high risk of thromboembolic events as judged by the investigator
Subjects at increased risk of cardiovascular disease as judged by the investigator

Contact the study team to confirm eligibility.