NCT01459562

Brief Summary

The purpose of this study is to determine the safety, pharmacodynamic and pharmacokinetic profiles of a novel therapeutic drug when administered to healthy volunteers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started Sep 2011

Longer than P75 for phase_1 healthy-volunteers

Geographic Reach
1 country

2 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

Study Start

First participant enrolled

September 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 25, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

August 9, 2023

Status Verified

August 1, 2023

Enrollment Period

1.3 years

First QC Date

October 17, 2011

Last Update Submit

August 7, 2023

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability of escalating single IV doses of NI-0501.

    AEs at: Study Day (SD) 1 pre-infusion, SD1 at 1, 2, 4, 8, 10, 12 hrs post infusion start, SD 2, SD 3, SD 5, SD 8, Wk 2, Wk 4, Wk 6, Wk 8

Secondary Outcomes (1)

  • Pharmacokinetics parameters, Determination of any pharmacodynamic effects, Immunogenicity of NI-0501

    PK/PD at: Study Day (SD) 1 pre-infusion, SD1 at 1, 2, 4, 8, 10 hrs post infusion start, SD 2, SD 3, SD 5, SD 8, Wk 2, Wk 4, Wk 6, Wk 8, Immunogenicity: SD1 pre-infusion, Wk 8

Study Arms (2)

NI-0501

EXPERIMENTAL
Drug: NI-0501

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

NI-0501DRUG
NI-0501
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy adults between 18 and 50 years old
  • non smokers
  • able to adhere to study protocol requirements

You may not qualify if:

  • any abnormal clinical safety laboratory parameters

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

HMR

London, United Kingdom

Location

ICON

Manchester, United Kingdom

Location

MeSH Terms

Interventions

Emapalumab

Study Officials

  • Steve Warrington, MD

    HMR

    PRINCIPAL INVESTIGATOR

  • Peter Dewland, MD

    ICON plc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2011

First Posted

October 25, 2011

Study Start

September 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

August 9, 2023

Record last verified: 2023-08

Locations

GB(2)