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Completed

NCT Number: NCT04511624

Single Dose Tolerability and Pharmacokinetics of IBI112 in Healthy Subjects

This is a the first in human study to evaluate the safety, tolerability, PK and PD of single subcutaneous or intravenous dose of IBI112 in healthy subjects

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Huashan Hospital Affiliated to Fudan University

Shanghai, China

About this study

In this first in human, phase 1, randomized, double-blind, placebo-controlled study, a single subcutaneous or intravenous dose of IBI112 will be administered to 46 healthy subjects.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male or female 18 to 45 years of age at the time of consent
  • BMI of 19-26Kg/m2 and weight of 50-100kg
  • Must provide written informed consent, and in the investigator's opinion, subject is able to understand the nature of the study and any risks involved in participation, and willing to cooperate and comply with the protocol restrictions and requirements

Exclusion criteria

  • Subjects who have a medical history of liver, kidney, cardiovascular, nervous / mental, gastrointestinal, respiratory, urinary, endocrine
  • Subjects who have a history of relapse or chronic infection, or a history of acute infection within 2 weeks;
  • Subjects who have previously used anti-IL-12 / 23 or anti-il-23 drugs;
  • Subjects who have clinically significant abnormalities determined by vital signs, physical examination, and laboratory measurements;
  • Subjects who are not suitable for this trial due to other reasons In the investigator' opinion

Treatment and study plan

IBI112 dose1

Drug

Drug: IBI112 SC dose1 Drug:placebo

IBI112 dose2

Drug

Drug: IBI112 SC dose2 Drug:placebo

IBI112 dose3

Drug

Drug: IBI112 SC dose3 Drug:placebo

IBI112 dose4

Drug

Drug: IBI112 SC dose4 Drug:placebo

IBI112 dose5

Drug

Drug: IBI112 IV dose5 Drug:placebo

IBI112 dose6

Drug

Drug: IBI112 SC dose6 Drug:placebo

IBI112 dose7

Drug

Drug: IBI112 IV dose7 Drug:placebo

Primary outcomes

  1. Incidence of treatment-emergent adverse events in healthy volunteers with single ascending doses of IBI112

    Time frame: Day1 to Day 113 post dose

Secondary outcomes

  1. Maximum Concentration (Cmax) - Pharmacokinetic Assessment

    Time frame: Day 113

    IV dose & SC dose

  2. Time to Maximum Concentration (Tmax) - Pharmacokinetic Assessment

    Time frame: Day 113

    SC dose

  3. Area Under the Curve Extrapolated to Infinity (AUC0-∞) - Pharmacokinetic Assessment

    Time frame: Day 113

    IV dose & SC dose

  4. Half-Life (t1/2) - Pharmacokinetic Assessment

    Time frame: Day 113

    IV dose & SC dose

  5. Volume of Distribution (Vd) - Pharmacokinetic Assessment

    Time frame: Day 113

    IV dose & SC dose

Sponsors and collaborators

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Industry

Registry information

Official study title

A Phase I Randomized, Double-Blind, Placebo-Controlled, Single Subcutaneous or Intravenous Ascending Dose Trial to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IBI112 in Healthy Subjects

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 13, 2020
Registry last updated
Sep 19, 2022

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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