NCT02976831

Study to Assess the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of AZD0284 in Healthy Subjects

Completed Phase 1 Last updated 14 June 2017

What this trial tests

Phase 1 trial testing AZD0284 in Plaque Psoriasis Vulgaris in 83 participants. Completed in 30 May 2017.

Timeline

9 December 2016

Primary endpoint
30 May 2017

30 May 2017

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	83
Start date	9 December 2016
Primary completion	30 May 2017
Estimated completion	30 May 2017
Sites	1 location across United Kingdom

Drugs / interventions tested

• AZD0284 — full drug profile →
• Placebo

Conditions studied

• Plaque Psoriasis Vulgaris — all drugs for Plaque Psoriasis Vulgaris →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 18 to 50, any sex, with Plaque Psoriasis Vulgaris. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Plaque psoriasis vulgaris is a chronic inflammatory skin disorder, affecting 1-3% of the population in Europe and the United States of America (USA) and represents one of the most prevalent immune inflammatory diseases. AZD0284 is a potent selective inverse agonist of RORg, which is being developed for the management of psoriasis. The current Phase 1 study investigates the safety, tolerability, food effect, pharmacokinetic (PK) and pharmacodynamic (PD) properties of single and repeated doses of AZD0284. The study will be conducted in healthy subjects. The study will be divided into 2 parts: Part 1 (SAD) and Part 2 (MAD), with Part 1 being split into 2 sub-parts: 1A (fasting) and 1B (fed). The results from this study will form the basis for decisions on future studies. The study will help to identify appropriate, well-tolerated doses that can be administered in subsequent studies in patients with psoriasis.

Publications & conference data

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

1. Small molecules to the rescue: Inhibition of cytokine signaling in immune-mediated diseases.
   Gadina M, Gazaniga N, Vian L, Furumoto Y. · · 2017 · cited 60× · PMID 28676205 · DOI 10.1016/j.jaut.2017.06.006
2. Pharmacokinetics, pharmacodynamics and safety of the inverse retinoic acid-related orphan receptor γ agonist AZD0284.
   Asimus S, Palmér R, Albayaty M, Forsman H, et al · · 2020 · cited 9× · PMID 32067249 · DOI 10.1111/bcp.14253