Single Dose Tolerability and Pharmacokinetics of IBI112 in Healthy Subjects

Study Overview
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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

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.

Official Title
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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

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: IBI112 dose1
* Drug: IBI112 dose2
* Drug: IBI112 dose3
* Drug: IBI112 dose4
* Drug: IBI112 dose5
* Drug: IBI112 dose6
* Drug: IBI112 dose7


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>IBI112 SC dose1 | Drug: IBI112 dose1<br>* Drug: IBI112 SC dose1 Drug:placebo<br>|
| Experimental: Cohort 2<br>IBI112 SC dose2 | Drug: IBI112 dose2<br>* Drug: IBI112 SC dose2 Drug:placebo<br>|
| Experimental: Cohort 3<br>IBI112 SC dose3 | Drug: IBI112 dose3<br>* Drug: IBI112 SC dose3 Drug:placebo<br>|
| Experimental: Cohort 4<br>IBI112 IV dose4 | Drug: IBI112 dose4<br>* Drug: IBI112 SC dose4 Drug:placebo<br>|
| Experimental: Cohort 5<br>IBI112 IV dose3 | Drug: IBI112 dose5<br>* Drug: IBI112 IV dose5 Drug:placebo<br>|
| Experimental: Cohort 6<br>IBI112 SC dose5 | Drug: IBI112 dose6<br>* Drug: IBI112 SC dose6 Drug:placebo<br>|
| Experimental: Cohort 7<br>IBI112 IV dose5 | Drug: IBI112 dose7<br>* Drug: IBI112 IV dose7 Drug:placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |