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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

NCT07794683 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2026-08-31

No results posted yet for this study

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

Conditions

  • Healthy Female Adult Volunteers

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.

Sponsors & Collaborators

  • Xentria, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2027-03-31
Completion
2027-03-31
FDA Drug
Yes

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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 NCT07794683 on ClinicalTrials.gov