Single Dose Tolerability and Pharmacokinetics of IBI112 in Healthy Subjects

Innovent Biologics

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: IBI112 dose2; Drug: IBI112 dose6; Drug: IBI112 dose3; Drug: IBI112 dose1; Drug: IBI112 dose4; Drug: IBI112 dose7; Drug: IBI112 dose5

Study type: Interventional

Funder types: Industry

Identifiers

NCT04511624

CIBI112A101

Details and patient eligibility

About

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

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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46 participants in 7 patient groups

Cohort 1

Experimental group

Description:

IBI112 SC dose1

Treatment:

Drug: IBI112 dose1

Cohort 2

Experimental group

Description:

IBI112 SC dose2

Treatment:

Drug: IBI112 dose2

Cohort 3

Experimental group

Description:

IBI112 SC dose3

Treatment:

Drug: IBI112 dose3

Cohort 4

Experimental group

Description:

IBI112 IV dose4

Treatment:

Drug: IBI112 dose4

Cohort 5

Experimental group

Description:

IBI112 IV dose3

Treatment:

Drug: IBI112 dose5

Cohort 6

Experimental group

Description:

IBI112 SC dose5

Treatment:

Drug: IBI112 dose6

Cohort 7

Experimental group

Description:

IBI112 IV dose5

Treatment:

Drug: IBI112 dose7