A Study to Compare Eutropin Formulations in Healthy Volunteers for Bioavailability, Safety, and Tolerability

NCT06743997 | Completed Phase 1

• 1 other identifier: LG-HGCL011
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized, Open Label, Single Subcutaneous Dose, 2x2 Crossover Study to Investigate the Relative Bioavailability, Safety and Tolerability among Different Eutropin Formulations in Healthy Volunteers

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• AUClast of somatropin

  AUClast will be used to evaluate the pharmacokinetics of somatropin

  0 to 24 hours post-dose

Secondary Outcomes (6)

• AUCinf of somatropin

  0 to 24 hours post-dose

• Cmax of somatropin

  0 to 24 hours post-dose

• Tmax of soatropin

  0 to 24 hours post-dose

• T1/2β of somatropin

  0 to 24 hours post-dose

• Change in IGF-1 levels

  0 to 24 hours post-dose

Study Arms (2)

Sequence 1

EXPERIMENTAL

Participants receive a single subcutaneous dose of the Test Drug(T), in the first period, followed by a washout period, and then a single subcutaneous dose of the Reference Drug(R) in the second period.

Drug: Test Drug (Eutropin Catridge, 48IU/Cartridge); Drug: Reference Drug (Eutropin, 4 IU/vial)

Sequence 2

EXPERIMENTAL

Participants receive a single subcutaneous dose of the Reference Drug(R), in the first period, followed by a washout period, and then a single subcutaneous dose of the Test Drug(T) in the second period.

Drug: Test Drug (Eutropin Catridge, 48IU/Cartridge); Drug: Reference Drug (Eutropin, 4 IU/vial)

Interventions

Test Drug (Eutropin Catridge, 48IU/Cartridge) DRUG

Liqid somatropin

Also known as: T, Test Drug

Sequence 1; Sequence 2

Reference Drug (Eutropin, 4 IU/vial) DRUG

Lyophilized somatropin

Also known as: R, Reference Drug

Sequence 1; Sequence 2

Eligibility Criteria

• Age: 19 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults aged 19 to 40years at screening.
• Voluntarily decide to participate and provide written informed consent.
• Able to receive the investigational product (IP) and pre-treatment drugs.
• Wiliing and able to comply with study requirements, including follow-up visits and blood/urine sampling.

You may not qualify if:

• History of conditions contraindicating somatropin or pre-treatment drugs.
• Clinically significant medical history.
• Participation in another clinical trial and receipt of an investigational product within 80 days prior to the first IP administration.

Sponsors & Collaborators

• LG Chem: lead

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

Location

MeSH Terms

Interventions

Drug Evaluation

Intervention Hierarchy (Ancestors)

Drug Development; Investigative Techniques; Evaluation Studies as Topic

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 20, 2024
• Study Start: January 13, 2025
• Primary Completion: April 15, 2025
• Study Completion: April 15, 2025
• Last Updated: April 17, 2025

Record last verified: 2024-12

Locations

KR (1)