A Study of IBI311 in Healthy Volunteers

Study Overview
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Brief Summary
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It is designed for Multi-center, double-masked, randomized, placebo- control study with dose escalation phase I trial to evaluate the safety, tolerability, PK and immunogenicity profiles of a single intravenous injection of IBI311 in healthy volunteers.

Official Title
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A Dose Escalation Phase I Clinical Study to Evaluate the Tolerability and Safety of a Single Intravenous Injection IBI311 in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Biological: placebo
* Biological: IBI311
* Biological: IBI311
* Biological: placebo
* Biological: placebo
* Biological: IBI311
* Biological: IBI311
* Biological: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing and able to sign informed consent form and comply with visit and study procedures per protocol. Male or female subjects with age of 18 45 yrs. Female subjects of childbearing age or male subjects with childbearing age female partner agree to take effective contraceptive measures from the screening period to 120 days after the end of treatment. Exclusion Criteria: Have a history of or any evidence of chronic diseases of liver, kidney, cardiovascular, nervous/mental, digestive tract, respiratory, urinary and endocrine systems. Have received prior treatment with another anti-IGF-1R monoclonal antibody. History of drug, alcohol, or chemical abuse within 6 months prior to screening. History of positive HIV antibody, HCV antibody, Syphilis check, HBV positive during screening period. Receipt of a live vaccine within 180 days prior to screening or expected to receive live vaccine during study period. History of recurrent significant infection or history of recurrent bacterial infections. Must not have a history of tinnitus or hearing impairment. Must not have received an investigational agent for any condition within 90 days. Female volunteers must not be pregnant or lactating.

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: treated with different doses of single intravenous injection of IBI311<br> | Biological: IBI311<br>* Dose2 IBI311 of single IV injection<br>Biological: IBI311<br>* Dose4 IBI311 of single IV injection<br>Biological: IBI311<br>* Dose1 IBI311 of single IV injection<br>Biological: IBI311<br>* Dose 3 IBI311 of single IV injection<br>|
| Placebo Comparator: Cohort 1: placebo group<br> | Biological: placebo<br>* Dose4 placebo of single IV injection<br>Biological: placebo<br>* Dose3 placebo of single IV injection<br>Biological: placebo<br>* Dose1 placebo of single IV injection<br>Biological: placebo<br>* Dose2 placebo of single IV injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence, relatedness and severity of all adverse events, treatment emergent adverse events and serious adverse events |  | Up to 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximum concentration (Cmax） | PK parameters maximum concentration (Cmax） of IBI311 | Up to 16 weeks. | 
| area under the curve (AUC) | PK parameters area under the curve (AUC) of IBI311 | Up to 16 weeks. | 
| half-life (t1/2) | PK parameters half-life (t1/2) of IBI311 | Up to 16 weeks. | 
| the incidence of ADA | Positive rate of anti-drug antibody | Up to 16 weeks |