> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-evaluating-the-pharmacokinetics-of-cm310-in-healthy-a5102fe9-24d2-4a89-bb14-1cd5987e33ff > Record changed: 2026-10-13 # Study Evaluating the Pharmacokinetics of CM310 in Healthy Subjects NCT06171048 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06171048) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06171048) Recruitment status Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06171048) Participants 236 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06171048) Lead sponsor Keymed Biosciences Co.Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06171048) Start date 2024-04-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06171048) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06171048) ## Title and summary **Summary** This is a single-center, randomized, open-label study to evaluate the pharmacokinetics of CM310 in healthy subjects. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06171048) **Short title** Study Evaluating the Pharmacokinetics of CM310 in Healthy Subjects Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06171048) **Official title** A Pharmacokinetics Study of CM310 Recombinant Humanized Monoclonal Antibody Injection in Healthy Subjects Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06171048) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06171048) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06171048) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06171048) **Recruitment status** Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06171048) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06171048) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06171048) ## Dates **Completion date** 2025-04-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06171048) **First posted** 2023-12-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06171048) **Registry last updated** 2023-12-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06171048) **Primary completion date** 2025-04-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06171048) **Start date** 2024-04-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06171048) ## Size and sites **Participants** 236 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06171048) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06171048) **Planned participants** 236 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06171048) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06171048) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06171048) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06171048) **Lead sponsor** Keymed Biosciences Co.Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06171048) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06171048) ## Identifiers **Registry ID** NCT06171048 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06171048) **ClinicalTrials.gov ID** NCT06171048 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06171048) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06171048) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06171048) ## Outcomes ### Primary outcomes 1. Pharmacokinetic: the maximum concentration (Cmax) Timeframe: up to week 6 Concentration and exposure Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06171048) ## Eligibility **Sex** Male **Age groups** Adults **Minimum age** 20 Years **Maximum age** 45 Years **Healthy volunteers** Yes ### Inclusion criteria - 20 years ≤ age ≤ 45 years. - Voluntarily participate in the study and sign the ICF. - Have the ability to understand the study. ### Exclusion criteria - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06171048) ## Sites - The Second Hospital of Anhui Medical UniversityHefei, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06171048) ## 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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