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A Study Of CinnoRA (Adalimumab-CinnaGen) And Adalimumab (Humira) In Healthy Subjects

NCT03273192 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2018-09-19

No results posted yet for this study

Summary

This study aims to demonstrate pharmacokinetic (PK) similarity of biosimilar candidate CinnoRA® relative to adalimumab reference product (Humira®) and evaluate safety and tolerability of CinnoRA®, in a parallel fashion in healthy volunteers after administration of a single dose (40 mg) of adalimumab.

The primary objective of this study is to demonstrate that the PK of CinnoRA® is similar to its originator, Humira®, 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 CinnoRA® and Humira®.
* To assess the safety of CinnoRA®.

Conditions

  • Bioequivalence
  • Phase 1

Interventions

DRUG

Adalimumab

A single 40-mg dose of Adalimumab is administered subcutaneously to all the subjects.

Sponsors & Collaborators

  • Cinnagen

    lead INDUSTRY

Principal Investigators

  • Somayeh Amini, PharmD · Orchid Pharmed Company

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-10-22
Primary Completion
2017-08-06
Completion
2017-08-06

Countries

  • Iran

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03273192 on ClinicalTrials.gov