A Clinical Study to Compare the Bioavailability of HR17031 in Healthy Subjects at Different Sites

NCT06086912 | Completed Phase 1

• 1 other identifier: HR17031-106
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the bioavailability and safety of HR17031 injection in healthy subjects at different sites.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (3)

• After a single subcutaneous injection of HR17031, the PK parameters of plasma Noiiglutide and serum INS068: Area Under the Concentration versus time curve (AUC0-t)

  Start of treatment up to Day 26

• After a single subcutaneous injection of HR17031, the PK parameters of plasma Noiiglutide and serum INS068: Area Under the Concentration versus time curve (AUC0-∞)

  Start of treatment up to Day 26

• After a single subcutaneous injection of HR17031, the PK parameters of plasma Noiiglutide and serum INS068: Maximum Concentration (Cmax)

  Start of treatment up to Day 26

Secondary Outcomes (7)

• After a single subcutaneous injection of HR17031, the PK parameters of plasma Noiiglutide and serum INS068: Time to maximum concentration (Tmax)

  Start of treatment up to Day 26

• After a single subcutaneous injection of HR17031, the PK parameters of plasma Noiiglutide and serum INS068: Apparent terminal half-life (t1/2)

  Start of treatment up to Day 26

• After a single subcutaneous injection of HR17031, the PK parameters of plasma Noiiglutide and serum INS068: Clearance (CL/F)

  Start of treatment up to Day 26

• After a single subcutaneous injection of HR17031, the PK parameters of plasma Noiiglutide and serum INS068: Apparent volume of distribution (Vz/F)

  Start of treatment up to Day 26

• Safety indicators: Adverse events (AE, including Injection site reactions, Hypoglycemia events, etc.), serious adverse events (SAE).

  Screening period up to Day 26

Study Arms (3)

sequence 1

EXPERIMENTAL

Drug: HR17031

sequence 2

EXPERIMENTAL

Drug: HR17031

sequence 3

EXPERIMENTAL

Drug: HR17031

Interventions

HR17031 DRUG

Receive a single dose of HR17031 at every period (First period：abdomen. Second period. upper arm. Third period: thigh).

sequence 1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Voluntary signing of informed consent form before related activities of the experiment and understanding of the procedures and methods of the experiment, willing to strictly follow the clinical trial protocol to complete the experiment.
• Both men and women are eligible, aged 18 to 55 years old (inclusive, as determined at the time of signing informed consent form).
• Body mass index (BMI) is between 18 and 27 kg/m2 (inclusive), with male weight ≥ 50 kg and female weight ≥ 45 kg.
• Fasting blood glucose level \< 6.1 mmol/L during screening period.

You may not qualify if:

• \. The following laboratory or auxiliary examination abnormalities are present during the screening period:
• Any abnormal laboratory examination with clinical significance. For laboratory examinations with clinical significance, if there is a clear and reasonable reason, retesting can be performed within one week and the retest results used to determine whether the subject meets the criteria;
• Abnormalities on 12-lead electrocardiogram (ECG) with clinical significance;
• Positive for hepatitis B surface antigen (HBsAg), positive for hepatitis C antibody (anti-HCV) (or diagnosed as active hepatitis), or positive for syphilis antibody;
• Positive for human immunodeficiency virus (HIV) serological test.
• \. The following diseases or medical history are present:
• History of hypertension, or systolic blood pressure outside the range of 90-140 mmHg or diastolic blood pressure outside the range of 60-90 mmHg during screening, and judged to have clinical significance by the investigator;
• Having a life-threatening disease within the past 5 years (except for basal cell carcinoma or squamous cell carcinoma of the skin);
• Having a severe systemic infection within the past 1 month;
• Having a history of acute or chronic pancreatitis, symptomatic gallbladder disease, or other risk factors for pancreatitis that may be present;
• Having a relevant history of gastrointestinal disease with persistent nausea and vomiting, including but not limited to: having had gastroparesis within the past 6 months that required treatment, unstable (worsening) or poorly controlled (persistent nausea and vomiting) gastroesophageal reflux disease (GERD), or surgery that affects gastric emptying;
• Having a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN2) with a genetic predisposition;
• Having a history of any clinically significant disease or condition that the investigator believes may affect the trial results, including but not limited to a history of cardiovascular, endocrine, neurological, digestive, urinary, hematological, immunological, metabolic diseases, or existing diseases in these systems.
• \. Medications (prescription or over-the-counter), food supplements, vitamins, and Chinese herbal medicines used within 2 weeks before the start of treatment are prohibited. Local application of eye/nose drops and ointments are allowed.
• \. The following conditions are prohibited:

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, 100032, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

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

Model Details: This study is a single-center, randomized, open-label, three-period, and three-sequence crossover design trial, consisting of three sequences (sequence 1, sequence 2 and sequence 3) and three periods (first period, second period and third period). Each sequence receives a same dose of HR17031 at every period.

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: October 17, 2023
• Study Start: November 7, 2023
• Primary Completion: December 12, 2023
• Study Completion: December 12, 2023
• Last Updated: February 1, 2024

Record last verified: 2024-01

Locations

CN (1)