Study to Evaluate Pharmacokinetics, Safety and Efficacy of CM310
NCT05702450
Phase
Phase 1
Recruitment status
Completed
Participants
Lead sponsor
Keymed Biosciences Co.Ltd
Start date
2023-03-22
Number of sites
- Summary
- This is a single-center, randomized, open study to evaluate the pharmacokinetics, safety and immunogenicity CM310 in healthy subjects.
- Short title
- Study to Evaluate Pharmacokinetics, Safety and Efficacy of CM310
- Official title
- A Randomized, Open, Parallel Phase I Clinical Study on the Comparison of Pharmacokinetics Characteristics of CM310 Recombinant Humanized Monoclonal Antibody Injection in Healthy Subjects
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2023-07-26
- First posted
- 2023-01-27
- Registry last updated
- 2024-10-15
- Primary completion date
- 2023-07-26
- Start date
- 2023-03-22
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Keymed Biosciences Co.Ltd
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05702450
- ClinicalTrials.gov ID
- NCT05702450
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
Sources for study design
Pharmacokinetic: the maximum concentration (Cmax)
Timeframe: up to 57 days
Concentration and exposure
Sources for outcomes
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 65 Years
- Healthy volunteers
- Yes
- Have the ability to understand the study.
- Voluntarily participate in the study and sign the ICF.
- 18 years ≤ age ≤ 65 years, male and female.
- Willing to take effective contraceptive measures during the study period.
- Plan to receive any major surgery during the study period.
- With malignant tumors within 5 years before screening.
- Positive results of alcohol breath test or urine drug abuse screening during screening period.
- Any reason that the investigator believes that will prevent the subject from participating in the study.
Sources for eligibility
- PKUCare Luzhong HospitalZibo, China
Sources for sites