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

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

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.

Study Overview

• Status: Completed
• Conditions: Therapeutic Equivalency
• Intervention / Treatment: Drug: Liraglutide injection; Drug: Liraglutide injection(Victoza®)

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shandong
    • Qingdao, Shandong, China, 266003
      • Phase I Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Liraglutide injection	Drug: Liraglutide injection; At a single dose of 0.6 mg of Liraglutide injection by subcutaneous injection
Active Comparator: Liraglutide injection(Victoza®)	Drug: Liraglutide injection(Victoza®); At a single dose of 0.6 mg of Liraglutide injection(Victoza®) by subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events	Collection of adverse events	40 days

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of Qingdao University

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2021
• Primary Completion (Actual): July 30, 2021
• Study Completion (Actual): August 19, 2021

Study Registration Dates

• First Submitted: January 28, 2022
• First Submitted That Met QC Criteria: February 4, 2022
• First Posted (Actual): February 7, 2022

Study Record Updates

• Last Update Posted (Actual): February 7, 2022
• Last Update Submitted That Met QC Criteria: February 4, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Liraglutide;Pharmacokinetic;bioequivalence
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Liraglutide
• Other Study ID Numbers: NBT-1698-P1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No