Healthy
Conditions
Brief summary
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.
Interventions
BIOLOGICALplacebo
Dose4 placebo of single IV injection
BIOLOGICALIBI311
Dose2 IBI311 of single IV injection
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Willing and able to sign informed consent form and comply with visit and study procedures per protocol. 2. Male or female subjects with age of 18\ 45 yrs. 3. 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
1. Have a history of or any evidence of chronic diseases of liver, kidney, cardiovascular, nervous/mental, digestive tract, respiratory, urinary and endocrine systems. 2. Have received prior treatment with another anti-IGF-1R monoclonal antibody. 3. History of drug, alcohol, or chemical abuse within 6 months prior to screening. 4. History of positive HIV antibody, HCV antibody, Syphilis check, HBV positive during screening period. 5. Receipt of a live vaccine within 180 days prior to screening or expected to receive live vaccine during study period. 6. History of recurrent significant infection or history of recurrent bacterial infections. 7. Must not have a history of tinnitus or hearing impairment. 8. Must not have received an investigational agent for any condition within 90 days. 9. Female volunteers must not be pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence, relatedness and severity of all adverse events, treatment emergent adverse events and serious adverse events | Up to 16 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| maximum concentration (Cmax） | Up to 16 weeks. | PK parameters maximum concentration (Cmax） of IBI311 |
| area under the curve (AUC) | Up to 16 weeks. | PK parameters area under the curve (AUC) of IBI311 |
| half-life (t1/2) | Up to 16 weeks. | PK parameters half-life (t1/2) of IBI311 |
| the incidence of ADA | Up to 16 weeks | Positive rate of anti-drug antibody |
Countries
China
Outcome results
None listed