A Randomized Phase 1 Study of Liralutide Injection in Healthy Chinese Subjects

Phase 1

Completed

• Conditions: Therapeutic Equivalency
• Interventions: Drug: Liraglutide injection(Victoza®); Drug: Liraglutide injection

• Registration Number: NCT05225974
• Lead Sponsor: The Affiliated Hospital of Qingdao University

Brief Summary

The study was designed as a single-site, randomized, open-label, crossover under fasted conditions. A single oral dose of 0.6 mg Liraglutide injection and Victoza® was given to the 32 healthy Chinese adult male volunteers.Blood samples were collected up to 72 h after administration.The primary pharmacokinetic endpoints were AUC0-t, AUC0-∞, and Cmax. Safety profile and immunogenicity data were collected from each subject.

Detailed Description

The study was designed as a single-site, randomized, open-label, crossover under fasted conditions. A single oral dose of 0.6 mg Liraglutide injection and Victoza® was given to the 32 healthy Chinese adult male volunteers.Volunteers were randomized 1:1 at the beginning to receive a single 0.6 mg dose of Victoza® or Liraglutide injection by subcutaneous injection during the first period. Following 7 days washout period, all subjects received the alternate formulation during the second period. Blood samples were collected up to 72 h after administration.The primary pharmacokinetic endpoints were AUC0-t, AUC0-∞, and Cmax. Safety profile and immunogenicity data were collected from each subject.

Study Timeline

• Study Start: 2021-07-16
• Primary Completion: 2021-07-30
• Study Completion: 2021-08-19
• Status Verified: 2022-01
• Study First Submitted: 2022-01-28
• Study First Submitted QC: 2022-02-04
• Last Update Submitted: 2022-02-04
• Study First Posted: 2022-02-07
• Last Update Posted: 2022-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 32

Inclusion Criteria

• Healthy male vulunteers aged 18 and above.
• The body mass index is in the range of 19.0-26.0 kg/m2 (including the critical value).
• Before the study, all subjects have been informed of the study's purpose, protocal, benefits, and risks, and signed the informed consent voluntarily.

Exclusion Criteria

• Medical examinations revealed clinically significant abnormalities or any evidence or history of clinically significant disease.
• Volunteers who had used systemic glucocorticoid drugs within 3 months before enrollment.
• Participation in another clinical trial within 3 months.
• Smoking more than 5 cigarettes per day during the 3 months prior to screening.
• Blood donation, massive blood loss (#400mL) or enrolled in other clinical trials 3 months prior to screening.
• Any use of other prescription drugs (including contraceptive)#over-thecounter drugs, Chinese herbal medicine, health care products and 30 days prior to medication for this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Liraglutide injection(Victoza®)	Liraglutide injection(Victoza®)	-
Liraglutide injection	Liraglutide injection	-

Primary Outcome Measures

Name	Time	Method
Area under the plasma concentration versus time curve (AUC)0-∞	40 days	Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞
Peak Plasma Concentration (Cmax)	40 days	Evaluation of Peak Plasma Concentration (Cmax)
Area under the plasma concentration versus time curve (AUC)0-t	40 days	Evaluation of Area under the plasma concentration versus time curve (AUC)0-t

Secondary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events	40 days	Collection of adverse events

Trial Locations

Locations (1)

Phase I Clinical Research Center; 🇨🇳 Qingdao, Shandong, China