Safety and Tolerance Study of IBI355 in Health Volunteers

Study Overview
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Brief Summary
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This study is being done to find out if IBI355 is safe and tolerance in health volunteers. The study will test increasing single doses of IBI355 given to adult health volunteers. The goal is to confirmed the safety of the highest dose of IBI355 or to find out the highest dose of IBI35 that can be given to health volunteer that dose not cause unacceptable side effects. Different dose regimens will be evaluated. The pharmacokinetics and ADA of IBI355 will also be evaluated.

Official Title
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A Phase 1, Double-blind Study to Evaluate the Safety and Tolerability of a Single-dose Administration of IBI355 in Health Adults

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: placebo
* Drug: IBI355


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who have decided to voluntarily participate in the study and provided a written consent regarding observance of precautions after having been informed of and having fully understood the objectives, methods, and effects of the study in detail; Healthy male and female aged 18 years or above ; Subject with a Body Mass Index (BMI)* between 18.5 and 28.0 kg/㎡; subjects with a normal laboratory examination，ECG， X-ray. Exclusion Criteria: Subjects with a history of allergy； Subjects participated in the other clinical trail in 1 month or less than 5 t1/2 since the previous clinical trial (which is longer)； Subjects with an infection requiring systemic medication was present within 30 days prior to randomization; HIV-Ab、RPR、HCV-Ab、HBV、HBeAg or HBcAb, one of them positive; There have a clinical or imaging evidence that the subject with active tuberculosis, or there is evidence that the subject is in the incubation period for tuberculosis; Patients with a history of central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic disorders and other systemic diseases; Subject with a hcg positive; Patients with a history of neuropsychiatry or who are considered unfit to participate in this clinical trial

Ages Eligible for Study
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Minimum Age: 18 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: IBI355 dose 1<br>IBI355 0.3mg/kg and placebo will be given to the subjects (3:2) | Drug: placebo<br>* placebo iv. once.<br>Drug: IBI355<br>* IBI355 iv. once.<br>|
| Experimental: IBI355 dose 4<br>IBI355 7.5mg/kg and placebo will be given to the subjects (6:2) | Drug: placebo<br>* placebo iv. once.<br>Drug: IBI355<br>* IBI355 iv. once.<br>|
| Experimental: IBI355 dose 6<br>IBI355 25mg/kg and placebo will be given to the subjects (6:2) | Drug: placebo<br>* placebo iv. once.<br>Drug: IBI355<br>* IBI355 iv. once.<br>|
| Experimental: IBI355 dose 7<br>IBI355 35mg/kg and placebo will be given to the subjects (6:2) | Drug: placebo<br>* placebo iv. once.<br>Drug: IBI355<br>* IBI355 iv. once.<br>|
| Experimental: IBI355 dose 2<br>IBI355 1mg/kg and placebo will be given to the subjects (6:2) | Drug: placebo<br>* placebo iv. once.<br>Drug: IBI355<br>* IBI355 iv. once.<br>|
| Experimental: IBI355 dose 3<br>IBI355 3mg/kg and placebo will be given to the subjects (6:2) | Drug: placebo<br>* placebo iv. once.<br>Drug: IBI355<br>* IBI355 iv. once.<br>|
| Experimental: IBI355 dose 5<br>IBI355 15mg/kg and placebo will be given to the subjects (6:2) | Drug: placebo<br>* placebo iv. once.<br>Drug: IBI355<br>* IBI355 iv. once.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of AE、SAE after receiving IBI 355 |  | week 0-12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under Curve, (AUC）、Maximum serum concentration of drug(Cmax）、Clearance (CL）、Apparent volume of distribution(V） and Half- life(t1/2）of IBI355 |  | week 0-12 |