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

Qingdao University

Status and phase

Completed

Phase 1

Conditions

Therapeutic Equivalency

Treatments

Drug: Liraglutide injection(Victoza®)

Drug: Liraglutide injection

Study type

Interventional

Funder types

Other

Identifiers

NCT05225974

NBT-1698-P1

Details and patient eligibility

About

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.

Full 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.

Enrollment

32 patients

Sex

Male

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.