Diabetes in Adults
Conditions
Brief summary
The objective of the study is to assess the safety, tolerability and pharmacokinetics of HR011408 at two formulations in healthy subject.
Interventions
DRUGHR011408 injection
Drug: HR011408 injection (formulation A), administered subcutaneously. Drug: HR011408 injection (formulation B), administered subcutaneously.
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Crossover Assigned to HR011408(formulation A) or HR011408(formulation B)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of adverse events (AEs) | from Day1 to Day15 | The incidence of adverse events will be collected and the safety of HR011408 will be assessed |
| Area under the concentration-time curve (AUC) | from 0 to 10 hours after dose administration | Area under the concentration-time curve (AUC) |
| Maximum observed concentration (Cmax) | from 0 to 10 hours after dose administration | Maximum observed concentration (Cmax) |
| Time to maximum observed concentration (Tmax) | from 0 to 10 hours after dose administration | Time to maximum observed concentration (Tmax) |
| Elimination half-life (t1/2) | from 0 to 10 hours after dose administration | Elimination half-life (t1/2) |
| Time to 50% maximum observed concentration (time to 50% Cmax) | from 0 to 10 hours after dose administration | Time to 50% maximum observed concentration (time to 50% Cmax) |
| Onset of appearance | from 0 to 10 hours after dose administration | First time point after dose administration when concentration reaches lower limit of quantification (LLOQ) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of development of Anti-drug Antibodies (ADAs) | from Day1 to Day15 after dose administration | Incidence of Anti-drug Antibodies (ADAs) will be assessed |
Countries
China
Outcome results
None listed