CompletedNCT01459562Updated Aug 9, 2023

First in Human Study of an Anti-IFN Gamma Monoclonal Antibody in Healthy Volunteers

A Phase 1 interventional study of NI-0501 and Placebo in Healthy Volunteers, sponsored by Swedish Orphan Biovitrum. Completed at 2 sites in United Kingdom. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-09.

Sponsored by Swedish Orphan Biovitrum · Phase 1, Interventional, and Basic science

Phase: Phase 1
Study type: Interventional
Enrollment: 20
Allocation: Randomized
Ages: 18 Years to 50 Years
Sex: All

Study 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.

Conditions studied

Healthy Volunteers

In context

Lead sponsor

Swedish Orphan Biovitrum is the lead sponsor of 78 studies on the registry; 4 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 15 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 50 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

any abnormal clinical safety laboratory parameters

Study design

Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Sequential assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 20 participants (actual)

Study arms

Experimental
NI-0501
Drug: NI-0501
Placebo comparator
Placebo
Drug: Placebo

Interventions

DrugNI-0501
DrugPlacebo

What researchers measure

Primary outcomes

Safety and tolerability of escalating single IV doses of NI-0501.
Time frame: 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

Pharmacokinetics parameters, Determination of any pharmacodynamic effects, Immunogenicity of NI-0501
Time frame: 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 locations

2 sites

HMR
London, United Kingdom
ICON
Manchester, United Kingdom

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01459562
Lead sponsor: Swedish Orphan Biovitrum
Responsible party: Sponsor
First posted: Oct 25, 2011
Start date: Sep 2011
Primary completion: Jan 2013
Completion: Jan 2013
Last update: Aug 9, 2023

Study contacts

Steve Warrington, MD

principal investigator · HMR

Peter Dewland, MD

principal investigator · ICON plc

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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