Single Dose Tolerability and Pharmacokinetics of IBI112 in Healthy Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-27

Study Completion Date

2022-07-22

Brief Summary

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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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Detailed Description

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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.

Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort 1

IBI112 SC dose1

Group Type EXPERIMENTAL

IBI112 dose1

Intervention Type DRUG

Drug: IBI112 SC dose1 Drug:placebo

Cohort 2

IBI112 SC dose2

Group Type EXPERIMENTAL

IBI112 dose2

Intervention Type DRUG

Drug: IBI112 SC dose2 Drug:placebo

Cohort 3

IBI112 SC dose3

Group Type EXPERIMENTAL

IBI112 dose3

Intervention Type DRUG

Drug: IBI112 SC dose3 Drug:placebo

Cohort 4

IBI112 IV dose4

Group Type EXPERIMENTAL

IBI112 dose4

Intervention Type DRUG

Drug: IBI112 SC dose4 Drug:placebo

Cohort 5

IBI112 IV dose3

Group Type EXPERIMENTAL

IBI112 dose5

Intervention Type DRUG

Drug: IBI112 IV dose5 Drug:placebo

Cohort 6

IBI112 SC dose5

Group Type EXPERIMENTAL

IBI112 dose6

Intervention Type DRUG

Drug: IBI112 SC dose6 Drug:placebo

Cohort 7

IBI112 IV dose5

Group Type EXPERIMENTAL

IBI112 dose7

Intervention Type DRUG

Drug: IBI112 IV dose7 Drug:placebo

Interventions

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IBI112 dose1

Drug: IBI112 SC dose1 Drug:placebo

Intervention Type DRUG

IBI112 dose2

Drug: IBI112 SC dose2 Drug:placebo

Intervention Type DRUG

IBI112 dose3

Drug: IBI112 SC dose3 Drug:placebo

Intervention Type DRUG

IBI112 dose4

Drug: IBI112 SC dose4 Drug:placebo

Intervention Type DRUG

IBI112 dose5

Drug: IBI112 IV dose5 Drug:placebo

Intervention Type DRUG

IBI112 dose6

Drug: IBI112 SC dose6 Drug:placebo

Intervention Type DRUG

IBI112 dose7

Drug: IBI112 IV dose7 Drug:placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes