Pharmacokinetics and Safety Profile of DA-3803, a Proposed Biosimilar of Recombinant Human Chorionic Gonadotropin, in Healthy Subjects

What Was Tested

This randomized controlled trial paper looks at hCG (human chorionic gonadotropin).

DA-3803 is a proposed biosimilar of recombinant human chorionic gonadotropin (r-hCG), which is a therapeutic protein used to treat infertility.

Who Took Part

The study group was 32 subjects.

By PubMed's age tags, the people studied were adults, both men and women.

How the Study Was Run

In design terms this was a randomized, single-blind and crossover study.

Random assignment meant chance, not the researchers, decided who got hCG (human chorionic gonadotropin) and who got the comparison, which limits bias.

Only one side, usually the subjects, was kept unaware of whether hCG (human chorionic gonadotropin) was given.

Each person switched between hCG (human chorionic gonadotropin) and the comparison at some point, usually with a gap in between.

What Was Measured

Topics PubMed links to this paper include Area Under Curve, Biological Availability, Chorionic Gonadotropin, Drug Monitoring, Healthy Volunteers, Infertility and Recombinant Fusion Proteins.

What This Means in Plain Language

The paper is a randomized, single-blind and crossover study of hCG (human chorionic gonadotropin) in 32 subjects.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

The abstract goes on to report its results in about 8 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2015 (BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy), a journal based in New Zealand.

More context: the hCG (human chorionic gonadotropin) compound page, all human trials.