Compare IBI305 and Bevacizumab on Pharmacokinetics/Safety/Immunogenicity on Healthy Male
NCT03083990 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2020-11-27
Summary
To confirm the PK similarity of IBI305 and bevacizumab in healthy volunteers .
Conditions
- Healthy
Interventions
- BIOLOGICAL
-
IBI305(Bevacizumab Biosimilar)
3mg/kg, infusion in 90minutes
- DRUG
-
Avastin(Bevacizumab)
3mg/kg, infusion in 90minutes
Sponsors & Collaborators
-
Innovent Biologics (Suzhou) Co. Ltd.
lead INDUSTRY
Principal Investigators
-
yanhua Ding, Doctor · Jilin University First Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-03-09
- Primary Completion
- 2017-08-17
- Completion
- 2017-08-17
Countries
- China
Study Locations
More Related Trials
-
A Pharmacokinetic Study Comparing MB02 And US And EU Avastin® In Healthy Male Volunteers
NCT03293654 ·Status: COMPLETED ·Phase: PHASE1
-
To Demonstrate Equivalent Pharmacokinetic Properties of HD204 and Bevacizumab (Avastin®) in Healthy Male Subjects
NCT03390673 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetic Study Comparing MB02 And US And EU Avastin® In Healthy Male Volunteers
NCT04238663 ·Status: COMPLETED ·Phase: PHASE1
-
A Study in Healthy People to Test How Well Repeated Doses of BI 3032950 Are Tolerated
NCT05985200 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB061 in Healthy Adult Volunteers
NCT02228707 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Test How Well Different Doses of BI 3804379 Are Tolerated by Healthy People
NCT06575400 ·Status: RECRUITING ·Phase: PHASE1
-
Pharmacokinetic Study of Belviq in Adult Korean Volunteers
NCT01880502 ·Status: COMPLETED ·Phase: PHASE1
-
Safety Tolerability and Pharmacokinetic of BI 411034
NCT01581684 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses of BI 163538 XX
NCT01587391 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase I Bioavailability and Pharmacokinetic Study of [14C]-Ipatasertib Single Oral and Intravenous Doses in Healthy Male Subjects
NCT02390492 ·Status: COMPLETED ·Phase: PHASE1
-
Bioequivalence and Safety Study of Bevacizumab-biosimilar (RPH-001) Compared to Bevacizumab-innovator
NCT03131700 ·Status: WITHDRAWN ·Phase: PHASE1
-
To Assess Safety, Tolerability and Pharmacokinetics of BI 416970 in Healthy Male Volunteers
NCT02093819 ·Status: COMPLETED ·Phase: PHASE1
-
A Study in Healthy Chinese People to Test How Different Doses of BI 1015550 Are Taken up in the Body
NCT05633862 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase I Study Comparing Pharmacokinetics and Safety of Bevacizumab
NCT03919448 ·Status: COMPLETED ·Phase: PHASE1
-
A Study in Healthy Men to Test How Different Doses of BI 3032950 Are Tolerated
NCT05518708 ·Status: COMPLETED ·Phase: PHASE1
-
Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB061 in Healthy Adult Volunteers Including Absolute Bioavailability and Food Effect
NCT02071121 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, and Pharmacokinetics of a Subcutaneous and Intravenous Dose of BI 655130 in Healthy Subjects
NCT03100903 ·Status: COMPLETED ·Phase: PHASE1
-
Pharmacokinetic, Safety, Tolerability, and Immunogenicity Study of SB8 in Healthy Male Subjects
NCT02453672 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, Pharmacokinetics of Single Rising Oral Doses of BI 1181181 in Healthy Male Volunteers, Including Investigation of the Effect of Food on the Bioavailability of BI 1181181
NCT02044406 ·Status: COMPLETED ·Phase: PHASE1
-
A Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of BIIB091, a Bruton's Tyrosine Kinase (BTK) Inhibitor, in Healthy Adult Participants
NCT03943056 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability and Pharmacokinetics of Increasing Repeated Doses of BIIF 1149 BS in Healthy Male Volunteers
NCT02203487 ·Status: COMPLETED ·Phase: PHASE1
-
A Clinical Trial to Compare the Pharmacokinetics and Safety of "BR1016A" With "BR1016B" in Healthy Volunteers
NCT05102903 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 639667
NCT02133482 ·Status: WITHDRAWN ·Phase: PHASE1
-
Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses of BI 187004 CL
NCT01587417 ·Status: COMPLETED ·Phase: PHASE1
-
To Demonstrate Similarity of Pharmacokinetics and Evaluate Safety of CT-P16, EU-Approved Avastin and US-licensed Avastin
NCT03247673 ·Status: COMPLETED ·Phase: PHASE1