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Completed

NCT Number: NCT05147259

A 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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Shandong Provincial Qianfoshan Hospital

Jinan, Shandong, 250014, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

HR011408 injection

Drug

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

Primary outcomes

  1. Incidence and severity of adverse events (AEs)

    Time frame: from Day1 to Day15

    The incidence of adverse events will be collected and the safety of HR011408 will be assessed

  2. Area under the concentration-time curve (AUC)

    Time frame: from 0 to 10 hours after dose administration

    Area under the concentration-time curve (AUC)

  3. Maximum observed concentration (Cmax)

    Time frame: from 0 to 10 hours after dose administration

    Maximum observed concentration (Cmax)

  4. Time to maximum observed concentration (Tmax)

    Time frame: from 0 to 10 hours after dose administration

    Time to maximum observed concentration (Tmax)

  5. Elimination half-life (t1/2)

    Time frame: from 0 to 10 hours after dose administration

    Elimination half-life (t1/2)

  6. Time to 50% maximum observed concentration (time to 50% Cmax)

    Time frame: from 0 to 10 hours after dose administration

    Time to 50% maximum observed concentration (time to 50% Cmax)

  7. Onset of appearance

    Time frame: from 0 to 10 hours after dose administration

    First time point after dose administration when concentration reaches lower limit of quantification (LLOQ)

Secondary outcomes

  1. Assessment of development of Anti-drug Antibodies (ADAs)

    Time frame: from Day1 to Day15 after dose administration

    Incidence of Anti-drug Antibodies (ADAs) will be assessed

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 7, 2021
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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