Single Dose Recombinant Human Follicle Stimulating Hormone Fc Husion Protein (KN015) in Healthy Volunteers

What Was Tested

This registered phase 1 trial tested Triptorelin.

Its indication is Controlled Ovarian Stimulation （COS）in combination with a gonadotropin releasing hormone (GnRH) antagonist for the development of multiple follicles in women participating in an ART program.

It had two arms (groups): Arm A (experimental) and Arm B (placebo comparator).

KN015, Triptorelin.

Placebo, Triptorelin.

The registry classes the interventions as drug.

More on the Plan

Eligible subjects will undergo down-regulation of endogenous FSH with a GnRH antagonist Triptorelin prior to receiving KN015.

Who Took Part

The registry lists 50 planned participants were the target.

It was open to women only aged from 18 years up to 40 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Able and willing to provide written informed consent. Age between 18 to 40 years (inclusive). Body weight ≥45 kg, body mass index (BMI) of ≥18 and ≤28 kg/m2,. Regular menstruation cycle (25 to 34 days, inclusive). Healthy female volunteer, normal findings in medical history and physical examinations.

The full record lists 9 inclusion and 22 exclusion criteria; among the exclusions: polycystic ovary syndrome (pcos); history of ovarian hyperstimulation syndrome (ohss); history of malignant disease.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

The participants were allocated by chance, so the Triptorelin group and the comparison group should start out alike.

The Triptorelin group and the comparison group ran side by side rather than switching.

As a double-blind Triptorelin study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2017-06 with completion listed for 2019-03.

It ran at 1 site in China.

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment(SAEs) and AEs of special interest (time frame: From screening to up to 36 days). Maximum observed serum concentration (Cmax) of KN015 in healthy Chinese female subjects. Time of Maximum observed serum concentration (Tmax) of KN015 in healthy Chinese female subjects.

It also tracked 4 secondary outcomes, for example Percentage of participants with anti-KN015 antibody.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Triptorelin in 50 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Triptorelin compound page, all human trials.