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

Therapeutic Equivalency Clinical Trial

Official title:

A Phase 1 Study of Liraglutide Injection and Victoza® in Healthy Chinese Subjects: An Open, Randomized, Single-Dose and Crossover Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05225974
• Other study ID #: NBT-1698-P1
• Status: Completed
• Phase: Phase 1
• Start date: July 16, 2021
• Est. completion date: August 19, 2021

Study information

• Verified date: January 2022
• Source: The Affiliated Hospital of Qingdao University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 19, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Therapeutic Equivalency

Intervention

Drug:
• Liraglutide injection
At a single dose of 0.6 mg of Liraglutide injection by subcutaneous injection
• Liraglutide injection(Victoza®)
At a single dose of 0.6 mg of Liraglutide injection(Victoza®) by subcutaneous injection

Locations

Country	Name	City	State
China	Phase I Clinical Research Center	Qingdao	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Hospital of Qingdao University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Plasma Concentration (Cmax)	Evaluation of Peak Plasma Concentration (Cmax)	40 days
Primary	Area under the plasma concentration versus time curve (AUC)0-t	Evaluation of Area under the plasma concentration versus time curve (AUC)0-t	40 days
Primary	Area under the plasma concentration versus time curve (AUC)0-8	Evaluation of Area under the plasma concentration versus time curve (AUC)0-8	40 days
Secondary	Incidence of Treatment-Emergent Adverse Events	Collection of adverse events	40 days