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

NCT ID: NCT05147259

Last Updated: 2021-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-29

Study Completion Date

2022-02-16

Brief Summary

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

Detailed Description

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Conditions

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Diabetes in Adults

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Crossover Assigned to HR011408(formulation A) or HR011408(formulation B)
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort one: Low dose

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

Group Type EXPERIMENTAL

HR011408 injection

Intervention Type DRUG

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

Cohort two: Medium dose

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

Group Type EXPERIMENTAL

HR011408 injection

Intervention Type DRUG

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

Cohort three: high dose

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

Group Type EXPERIMENTAL

HR011408 injection

Intervention Type DRUG

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

Interventions

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HR011408 injection

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Sheng Feng, Ph.D.

Role: CONTACT

Phone: +86-0518-82342973

Email: [email protected]

Yifan Li

Role: CONTACT

Phone: +86-0518-82342973

Email: [email protected]

Other Identifiers

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HR011408-101

Identifier Type: -

Identifier Source: org_study_id