NCT07175506 Study of CM559 in Healthy Subjects
| NCT ID | NCT07175506 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Keymed Biosciences Co.Ltd |
| Condition | Healthy Subjects |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-09 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2025-09 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is a single center, randomized, double-blind, placebo-controlled, single dose, dose escalation Phase I clinical study aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM559 administered intravenously at different doses in healthy male subjects.
Eligibility Criteria
Inclusion Criteria: * Subjects age ≥ 18 years \& ≤60 years. * Subjects voluntarily signed the Informed Consent Form and were able to comply with the provisions of this protocol. Exclusion Criteria: * The average number of cigarettes smoked per day is greater than 5 within 3 months prior to screening. * Drinking heavily within 3 months prior to screening, or unable to guarantee not to drink alcohol during the research period, or positive alcohol breath testing. * History of drug abuse within 1 year prior to screening, or positive urine drug abuse screening. * Blood donation or any other form of blood loss exceeding 400mL, or accepting blood transfusion within 12 weeks prior to screening. * Suspected allergy to Aβ-antibody drugs, humanized monoclonal antibody drugs and their excipients, or other biological agents, or have a history of severe allergic reactions to other drugs. * Severe trauma or undergo major surgery within 3 months prior to screening,or planned surgery during the research period.
Contact & Investigator
Mengchang Yang
STUDY CHAIR
Sichuan Provincial People's Hospital
Frequently Asked Questions
Who can join the NCT07175506 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 60 Years, studying Healthy Subjects. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07175506 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07175506 currently recruiting?
Yes, NCT07175506 is actively recruiting participants. Contact the research team at qianjia@keymedbio.com for enrollment information.
Where is the NCT07175506 trial being conducted?
This trial is being conducted at Chengdu, China.
Who is sponsoring the NCT07175506 clinical trial?
NCT07175506 is sponsored by Keymed Biosciences Co.Ltd. The principal investigator is Mengchang Yang at Sichuan Provincial People's Hospital. The trial plans to enroll 40 participants.