NCT05147259

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2021

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

November 26, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 7, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2022

Completed
Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

2 months

First QC Date

November 24, 2021

Last Update Submit

May 20, 2026

Conditions

Diabetes in Adults

Outcome Measures

Primary Outcomes (7)

  • 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 Outcomes (1)

  • Assessment of development of Anti-drug Antibodies (ADAs)

    from Day1 to Day15 after dose administration

Study Arms (3)

Cohort one: Low dose

EXPERIMENTAL

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

Drug: HR011408 injection

Cohort two: Medium dose

EXPERIMENTAL

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

Drug: HR011408 injection

Cohort three: high dose

EXPERIMENTAL

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

Drug: HR011408 injection

Interventions

HR011408 injectionDRUG

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

Cohort one: Low doseCohort three: high doseCohort two: Medium dose

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female aged 18-55 years (both inclusive) at the time of signing informed consent.
  • Body mass index 18.0-26.0kg/m2 (both inclusive).
  • Body weight ≥ 50.0 kg (male),≥ 45.0 kg (female).
  • Fasting serum/plasma glucose \< 6.1 mmol/L.

You may not qualify if:

  • Known or suspected of being allergic to any ingredient in the study drug.
  • Participated in any drug or medical device-related clinical trial within 3 months before screening.
  • Subjects addicted to smoking, or non-smoker who smoked within 48 hours before administration.
  • 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.
  • Subjects with incompetence or language impairment, who cannot fully understand or participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shandong Provincial Qianfoshan Hospital

Jinan, Shandong, 250014, China

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Crossover Assigned to HR011408(formulation A) or HR011408(formulation B)
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2021

First Posted

December 7, 2021

Study Start

November 26, 2021

Primary Completion

January 22, 2022

Study Completion

January 22, 2022

Last Updated

May 22, 2026

Record last verified: 2026-05

Locations

CN(1)