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

NCT05225974 | Completed Phase 1

• 1 other identifier: NBT-1698-P1
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Therapeutic Equivalency

Keywords

Liraglutide;Pharmacokinetic;bioequivalence

Outcome Measures

Primary Outcomes (3)

• Peak Plasma Concentration (Cmax)

  Evaluation of Peak Plasma Concentration (Cmax)

  40 days

• 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

• Area under the plasma concentration versus time curve (AUC)0-∞

  Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞

  40 days

Secondary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  40 days

Study Arms (2)

Liraglutide injection

EXPERIMENTAL

Drug: Liraglutide injection

Liraglutide injection(Victoza®)

ACTIVE COMPARATOR

Drug: Liraglutide injection(Victoza®)

Interventions

Liraglutide injection DRUG

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

Liraglutide injection

Liraglutide injection(Victoza®) DRUG

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

Liraglutide injection(Victoza®)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

Phase I Clinical Research Center

Qingdao, Shandong, 266003, China

Location

MeSH Terms

Interventions

Liraglutide

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

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

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: February 7, 2022
• Study Start: July 16, 2021
• Primary Completion: July 30, 2021
• Study Completion: August 19, 2021
• Last Updated: February 7, 2022

Record last verified: 2022-01

Locations

CN (1)