Single Dose Tolerability and Pharmacokinetics of IBI112 in Healthy Subjects

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: IBI112 dose1; Drug: IBI112 dose2; Drug: IBI112 dose3; Drug: IBI112 dose4; Drug: IBI112 dose5; Drug: IBI112 dose6; Drug: IBI112 dose7

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Huashan Hospital Affiliated to Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy male or female 18 to 45 years of age at the time of consent
2. BMI of 19-26Kg/m2 and weight of 50-100kg
3. 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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: DOUBLE

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Cohort 1; IBI112 SC dose1	Drug: IBI112 dose1; Drug: IBI112 SC dose1 Drug:placebo
EXPERIMENTAL: Cohort 2; IBI112 SC dose2	Drug: IBI112 dose2; Drug: IBI112 SC dose2 Drug:placebo
EXPERIMENTAL: Cohort 3; IBI112 SC dose3	Drug: IBI112 dose3; Drug: IBI112 SC dose3 Drug:placebo
EXPERIMENTAL: Cohort 4; IBI112 IV dose4	Drug: IBI112 dose4; Drug: IBI112 SC dose4 Drug:placebo
EXPERIMENTAL: Cohort 5; IBI112 IV dose3	Drug: IBI112 dose5; Drug: IBI112 IV dose5 Drug:placebo
EXPERIMENTAL: Cohort 6; IBI112 SC dose5	Drug: IBI112 dose6; Drug: IBI112 SC dose6 Drug:placebo
EXPERIMENTAL: Cohort 7; IBI112 IV dose5	Drug: IBI112 dose7; Drug: IBI112 IV dose7 Drug:placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of treatment-emergent adverse events in healthy volunteers with single ascending doses of IBI112	Day1 to Day 113 post dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Concentration (Cmax) - Pharmacokinetic Assessment	IV dose & SC dose	Day 113
Time to Maximum Concentration (Tmax) - Pharmacokinetic Assessment	SC dose	Day 113
Area Under the Curve Extrapolated to Infinity (AUC0-∞) - Pharmacokinetic Assessment	IV dose & SC dose	Day 113
Half-Life (t1/2) - Pharmacokinetic Assessment	IV dose & SC dose	Day 113
Volume of Distribution (Vd) - Pharmacokinetic Assessment	IV dose & SC dose	Day 113

Collaborators and Investigators

• Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 27, 2020
• Primary Completion (ACTUAL): July 22, 2022
• Study Completion (ACTUAL): July 22, 2022

Study Registration Dates

• First Submitted: August 3, 2020
• First Submitted That Met QC Criteria: August 12, 2020
• First Posted (ACTUAL): August 13, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 19, 2022
• Last Update Submitted That Met QC Criteria: September 16, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CIBI112A101

Drug and device information, study documents

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