> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-to-evaluate-pharmacokinetics-safety-and-efficacy-of-ab7a0654-9fba-4ea4-98a6-77e686376ca9 > Record changed: 2026-10-13 # Study to Evaluate Pharmacokinetics, Safety and Efficacy of CM310 NCT05702450 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702450) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702450) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702450) Participants 240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702450) Lead sponsor Keymed Biosciences Co.Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702450) Start date 2023-03-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702450) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702450) ## Title and summary **Summary** This is a single-center, randomized, open study to evaluate the pharmacokinetics, safety and immunogenicity CM310 in healthy subjects. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702450) **Short title** Study to Evaluate Pharmacokinetics, Safety and Efficacy of CM310 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702450) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702450) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702450) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702450) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702450) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702450) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702450) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702450) ## Dates **Completion date** 2023-07-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702450) **First posted** 2023-01-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702450) **Registry last updated** 2024-10-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702450) **Primary completion date** 2023-07-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702450) **Start date** 2023-03-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702450) ## Size and sites **Actual participants** 240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702450) **Participants** 240 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702450) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702450) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702450) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702450) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702450) **Lead sponsor** Keymed Biosciences Co.Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702450) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702450) ## Identifiers **Registry ID** NCT05702450 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702450) **ClinicalTrials.gov ID** NCT05702450 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702450) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702450) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702450) ## Outcomes ### Primary outcomes 1. Pharmacokinetic: the maximum concentration (Cmax) Timeframe: up to 57 days Concentration and exposure Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702450) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 65 Years **Healthy volunteers** Yes ### Inclusion criteria - 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. ### Exclusion criteria - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702450) ## Sites - PKUCare Luzhong HospitalZibo, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05702450) ## Related records ### Drugs (1) - [Stapokibart](https://trialight.com/data/asset/stapokibart-cf91b0c3-2312-4ec3-934f-c6f1ea95d567.md) ### Lead sponsors (1) - [Keymed Biosciences Co.Ltd](https://trialight.com/data/company/keymed-biosciences-co-ltd-30e31955-895d-4c47-970a-b1b18f150234.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. Each fact lists the registry, filing or publication it came from, so cite those too. - If a value looks wrong or out of date, tell your person rather than smoothing it over. 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