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

Hengrui Medicine

Status and phase: Unknown; Phase 1

Conditions: Diabetes in Adults

Treatments: Drug: HR011408 injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT05147259

HR011408-101

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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 ≥50.0kg(male),≥45.0kg(female)
4. Fasting serum/plasma glucose <6.1mmol/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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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60 participants in 3 patient groups

Cohort one: Low dose

Experimental group

Description:

Subjects will be randomized to a treatment sequence consisting of two treatment periods: received two formulation HR011408 injections successively

Treatment:

Drug: HR011408 injection

Cohort two: Medium dose

Experimental group

Description:

Subjects will be randomized to a treatment sequence consisting of two treatment periods: received two formulation HR011408 injections successively

Treatment:

Drug: HR011408 injection

Cohort three: high dose

Experimental group

Description:

Subjects will be randomized to a treatment sequence consisting of two treatment periods: received two formulation HR011408 injections successively

Treatment:

Drug: HR011408 injection