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NOT YET RECRUITING
NCT07794683
PHASE1

A Study to Investigate the Pharmacokinetics and Safety of KM04 Compared to United States (US)-Gonal-f Revised Formulation Female (RFF) Redi-ject and European Union (EU)-Gonal-f in Healthy Adult Female Volunteers

Sponsor: Xentria, Inc.

View on ClinicalTrials.gov

Summary

A study to investigate the pharmacokinetics and safety of KM04 compared to United States (US)-Gonal-f Revised Formulation Female (RFF) Redi-ject and European Union (EU)-Gonal-f in healthy adult female volunteers

Official title: A Single Center, Single-Dose, Double-Blind, Randomized, Three-Treatment, Three-Period, Six-Sequence, Crossover Study to Demonstrate Pharmacokinetic Similarity Between KM04, US-Gonal-f® RFF Redi-ject®, EU-Gonal-f®, and to Evaluate Safety in Healthy Adult Female Volunteers

Key Details

Gender

FEMALE

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

42

Start Date

2026-10

Completion Date

2027-03

Last Updated

2026-08-31

Healthy Volunteers

Yes

Interventions

DRUG

KM04

Participants will receive a single subcutaneous dose of 300 International Unit (IU) in either Treatment Period 1, Treatment Period 2, or Treatment Period 3.

DRUG

Unites States (US)-Gonal-f® Revised Formulation Female (RFF) Redi-ject®

Participants will receive a single subcutaneous dose of 300 IU in either Treatment Period 1, Treatment Period 2, or Treatment Period 3.

DRUG

European Union (EU)-Gonal-f®

Participants will receive a single subcutaneous dose of 300 IU in either Treatment Period 1, Treatment Period 2, or Treatment Period 3.