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

NCT ID: NCT05225974

Last Updated: 2022-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-16
• Study Completion Date: 2021-08-19

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.

Conditions

Therapeutic Equivalency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Liraglutide injection

Group Type: EXPERIMENTAL

Liraglutide injection

Intervention Type: DRUG

At a single dose of 0.6 mg of Liraglutide injection by subcutaneous injection

Liraglutide injection(Victoza®)

Group Type: ACTIVE_COMPARATOR

Liraglutide injection(Victoza®)

Intervention Type: DRUG

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

Interventions

Liraglutide injection

At a single dose of 0.6 mg of Liraglutide injection by subcutaneous injection

Intervention Type: DRUG

Liraglutide injection(Victoza®)

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Phase I Clinical Research Center

Qingdao, Shandong, China

Countries

China

Other Identifiers

NBT-1698-P1

Identifier Type: -

Identifier Source: org_study_id