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

A Single Center, Randomized, Double-Blind, Single Ascending Dose, Crossover Designed Study to Evaluate the Safety, Tolerability and Pharmacokinetics of HR011408 at Two Formulations in Healthy Subject

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

Study Overview

• Status: Completed
• Conditions: Diabetes in Adults
• Intervention / Treatment: Drug: HR011408 injection

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250014
      • Shandong Provincial Qianfoshan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 51 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort one: Low dose; Subjects will be randomized to a treatment sequence consisting of two treatment periods: received two formulation HR011408 injections successively	Drug: HR011408 injection; Drug: HR011408 injection (formulation A), administered subcutaneously. Drug: HR011408 injection (formulation B), administered subcutaneously.
Experimental: Cohort two: Medium dose; Subjects will be randomized to a treatment sequence consisting of two treatment periods: received two formulation HR011408 injections successively	Drug: HR011408 injection; Drug: HR011408 injection (formulation A), administered subcutaneously. Drug: HR011408 injection (formulation B), administered subcutaneously.
Experimental: Cohort three: high dose; Subjects will be randomized to a treatment sequence consisting of two treatment periods: received two formulation HR011408 injections successively	Drug: HR011408 injection; Drug: HR011408 injection (formulation A), administered subcutaneously. Drug: HR011408 injection (formulation B), administered subcutaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and severity of adverse events (AEs)	The incidence of adverse events will be collected and the safety of HR011408 will be assessed	from Day1 to Day15
Area under the concentration-time curve (AUC)	Area under the concentration-time curve (AUC)	from 0 to 10 hours after dose administration
Maximum observed concentration (Cmax)	Maximum observed concentration (Cmax)	from 0 to 10 hours after dose administration
Time to maximum observed concentration (Tmax)	Time to maximum observed concentration (Tmax)	from 0 to 10 hours after dose administration
Elimination half-life (t1/2)	Elimination half-life (t1/2)	from 0 to 10 hours after dose administration
Time to 50% maximum observed concentration (time to 50% Cmax)	Time to 50% maximum observed concentration (time to 50% Cmax)	from 0 to 10 hours after dose administration
Onset of appearance	First time point after dose administration when concentration reaches lower limit of quantification (LLOQ)	from 0 to 10 hours after dose administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of development of Anti-drug Antibodies (ADAs)	Incidence of Anti-drug Antibodies (ADAs) will be assessed	from Day1 to Day15 after dose administration

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2021
• Primary Completion (Actual): January 22, 2022
• Study Completion (Actual): January 22, 2022

Study Registration Dates

• First Submitted: November 24, 2021
• First Submitted That Met QC Criteria: November 24, 2021
• First Posted (Actual): December 7, 2021

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: HR011408-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No