Study Results
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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COMPLETED
PHASE1
28 participants
INTERVENTIONAL
2022-08-10
2023-01-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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Cohort 1: treated with different doses of single intravenous injection of IBI311
IBI311
Dose2 IBI311 of single IV injection
IBI311
Dose4 IBI311 of single IV injection
IBI311
Dose1 IBI311 of single IV injection
IBI311
Dose 3 IBI311 of single IV injection
Cohort 1: placebo group
placebo
Dose4 placebo of single IV injection
placebo
Dose3 placebo of single IV injection
placebo
Dose1 placebo of single IV injection
placebo
Dose2 placebo of single IV injection
Interventions
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placebo
Dose4 placebo of single IV injection
IBI311
Dose2 IBI311 of single IV injection
IBI311
Dose4 IBI311 of single IV injection
placebo
Dose3 placebo of single IV injection
placebo
Dose1 placebo of single IV injection
IBI311
Dose1 IBI311 of single IV injection
IBI311
Dose 3 IBI311 of single IV injection
placebo
Dose2 placebo of single IV injection
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
45 Years
ALL
Yes
Sponsors
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Innovent Biologics (Suzhou) Co. Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Yongfang Yuan, Ph D.
Role: PRINCIPAL_INVESTIGATOR
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Locations
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Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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CIBI311A101
Identifier Type: -
Identifier Source: org_study_id
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