NCT03273088

Pharmacokinetic, Safety and Tolerability Study of Altebrel in Healthy Male Subjects

Completed Phase 1 Last updated 19 September 2018

What this trial tests

Phase 1 trial testing Etanercept in Phase 1 in 34 participants. Completed in 15 March 2017.

Timeline

4 December 2016

Primary endpoint
15 March 2017

15 March 2017

Quick facts

Lead sponsor	AryoGen Pharmed Co.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	basic science
Enrollment	34
Start date	4 December 2016
Primary completion	15 March 2017
Estimated completion	15 March 2017
Sites	1 location across Iran

Drugs / interventions tested

• Etanercept (etanercept) — full drug profile →

Conditions studied

• Phase 1 — all drugs for Phase 1 →
• Bioequivalence — all drugs for Bioequivalence →

Sponsor

AryoGen Pharmed Co. — full company profile →

Who can join

Adults 18 to 55, male only, with Phase 1 or Bioequivalence. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study aims to demonstrate pharmacokinetic (PK) similarity of biosimilar candidate Altebrel relative to etanercept reference product (Enbrel®) and evaluate safety and tolerability of Altebrel, in a crossover fashion in healthy male volunteers after administration of a single dose (25 mg) of etanercept.

The primary objective of this study is to demonstrate that the PK of Altebrel is similar to its originator, Enbrel®, as assessed by the area under the serum concentration time curve (AUC) from time 0 extrapolated to infinity (AUCinf) and the Cmax.

The secondary objectives of the study are:

To further compare the PK of Altebrel and Enbrel®. To assess the safety of Altebrel.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.