A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HR011408 at Two Formulations in Healthy Subject

Jiangsu HengRui Medicine Co., Ltd.62 enrolled

Overview

The objective of the study is to assess the safety, tolerability and pharmacokinetics of HR011408 at two formulations in healthy subject.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Diabetes in Adults

Interventions

HR011408 injectionDRUG

Drug: HR011408 injection (formulation A), administered subcutaneously. Drug: HR011408 injection (formulation B), administered subcutaneously.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male or female aged 18-55 years (both inclusive) at the time of signing informed consent. 2. Body mass index 18.0-26.0kg/m2 (both inclusive). 3. Body weight ≥ 50.0 kg (male),≥ 45.0 kg (female). 4. Fasting serum/plasma glucose \< 6.1 mmol/L. Exclusion Criteria: 1. Known or suspected of being allergic to any ingredient in the study drug. 2. Participated in any drug or medical device-related clinical trial within 3 months before screening. 3. Subjects addicted to smoking, or non-smoker who smoked within 48 hours before administration. 4. Donated blood within 1 month before screening; or donated blood ≥ 400 mL or had blood loss ≥ 400 mL during trauma or major surgery within 3 months before screening. 5. Subjects with incompetence or language impairment, who cannot fully understand or participate in the study.

Locations (1)

Shandong Provincial Qianfoshan Hospital

Jinan, Shandong, China

Outcomes

Primary Outcomes

Incidence and severity of adverse events (AEs)

The incidence of adverse events will be collected and the safety of HR011408 will be assessed

Time frame: from Day1 to Day15

Area under the concentration-time curve (AUC)