Study Evaluating the Pharmacokinetics of CM310 in Healthy Subjects
NCT06171048
Phase
Phase 1
Recruitment status
Unknown
Participants
Lead sponsor
Keymed Biosciences Co.Ltd
Start date
2024-04-30
Number of sites
- Summary
- This is a single-center, randomized, open-label study to evaluate the pharmacokinetics of CM310 in healthy subjects.
- Short title
- Study Evaluating the Pharmacokinetics of CM310 in Healthy Subjects
- Official title
- A Pharmacokinetics Study of CM310 Recombinant Humanized Monoclonal Antibody Injection in Healthy Subjects
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2025-04-30
- First posted
- 2023-12-14
- Registry last updated
- 2023-12-14
- Primary completion date
- 2025-04-30
- Start date
- 2024-04-30
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Keymed Biosciences Co.Ltd
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06171048
- ClinicalTrials.gov ID
- NCT06171048
- 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 week 6
Concentration and exposure
Sources for outcomes
- Sex
- Male
- Age groups
- Adults
- Minimum age
- 20 Years
- Maximum age
- 45 Years
- Healthy volunteers
- Yes
- 20 years ≤ age ≤ 45 years.
- Voluntarily participate in the study and sign the ICF.
- Have the ability to understand the study.
- With history of chronic or serious illness.
- With any medication within 28 days prior to administration;
- Plan to undergo surgery during the research period;
- With any situations unsuitable to participate in this study.
Sources for eligibility
- The Second Hospital of Anhui Medical UniversityHefei, China
Sources for sites