NCT01818024

A Study to Investigate the Safety Tolerability Pharmacokinetics, and Pharmacodynamics of Inhaled and Intravenous GSK2862277 in Healthy Volunteers

Completed Phase 1 Last updated 15 May 2017

What this trial tests

Phase 1 trial testing Single IV dose of GSK2862277 in Respiratory Disorders in 54 participants. Completed in 25 October 2013.

Timeline

22 February 2013

Primary endpoint
25 October 2013

25 October 2013

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	single
Primary purpose	treatment
Enrollment	54
Start date	22 February 2013
Primary completion	25 October 2013
Estimated completion	25 October 2013
Sites	1 location across United Kingdom

Drugs / interventions tested

• Single IV dose of GSK2862277 — full drug profile →
• Matching placebo single dose IV infusion — full drug profile →
• Single IH dose of GSK2862277 — full drug profile →
• Matching placebo single dose IH
• Repeat IV dose of GSK2862277 — full drug profile →
• Matching placebo repeat dose IV infusion
• Repeat IH dose selected of GSK2862277 from Part 2 — full drug profile →
• Matching placebo repeat dose IH

Conditions studied

• Respiratory Disorders — all drugs for Respiratory Disorders →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 65, any sex, with Respiratory Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This will be a 3 part study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeat doses of GSK2862277 administered via inhalation (IH) or intravenous (IV) routes in healthy subjects.

Part 1 of this study will involve an initial assessment of safety, tolerability and pharmacokinetics of GSK286227, via single escalating intravenous doses, compared to a predecessor molecule, GSK1995057. After completion of Part 1 an interim data review will occur which will assess key comparability criteria to inform progression to Part 2 of the study.

Part 2 of the study will involve single doses of GSK2862277 at a level predicted to be at or close to therapeutic dose levels. Part 2 will investigate both intravenous and inhaled routes of administration, in sequential manner, respectively. An interim data review will also occur after completion of Part 2, where all data accumulated previously will be assessed to examine appropriateness to progress to Part 3.

Part 3 of the study will involve 5 days of repeat dosing via both inhaled and intravenous routes using the same dose administered in Part 2.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Nanobodies: Robust miniprotein binders in biomedicine.
   Yong Joon Kim J, Sang Z, Xiang Y, Shen Z, et al · · 2023 · cited 46× · PMID 36754285 · DOI 10.1016/j.addr.2023.114726
2. Exploring TNFR1: from discovery to targeted therapy development.
   Li Y, Ye R, Dai H, Lin J, et al · · 2025 · cited 33× · PMID 39815286 · DOI 10.1186/s12967-025-06122-0
3. Therapeutic antibodies - natural and pathological barriers and strategies to overcome them.
   Al Ojaimi Y, Blin T, Lamamy J, Gracia M, et al · · 2022 · cited 27× · PMID 34687769 · DOI 10.1016/j.pharmthera.2021.108022