Single Ascending Dose Study of CM338 in Healthy Volunteers
- Registration Number
- NCT05186285
- Lead Sponsor
- Keymed Biosciences Co.Ltd
- Brief Summary
This study was a single-center, randomized, double blind, placebo-controlled, single-dose, dose-increasing study to evaluate the safety, tolerability, PK characteristics, PD effect, and immunogenicity of CM338 injection administered intravenously or subcutaneously at different doses in healthy subjects.
- Detailed Description
The study included screening period, baseline period, administration and hospitalization observation period, and safety follow-up period.
Sixty-six healthy volunteers will be enrolled and randomized into 8 groups.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 66
- with the ability to understand this study and voluntarily sign the informed consent form.
- 18 to 65 years of age.
- with normal or abnormal without clinically significance on medical history, vital signs, physical examination, 12-lead ECG, laboratory examination, chest X-ray, and abdominal color ultrasound, etc.
- able to communicate with the researchers and follow the requirements specified in the protocol.
- agree to use effective contraceptive methods from signing the ICF to 6 months after the administration.
- plan to conduct any major surgery during the study.
- known allergy to monoclonal antibody drugs or other related drugs, or to the excipients of CM338 injection.
- with any clinical history including serious diseases or circulatory system, endocrine system, nervous system, blood system, immune system, mental system and metabolic abnormalities.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description CM338 120mg, IV CM338 120mg, single dose, IV CM338 240mg, SC CM338 240mg, single dose, SC CM338 60mg, IV CM338 60mg, single dose, IV CM338 30mg, IV CM338 30mg, single dose, IV CM338 240mg, IV CM338 240mg, single dose, IV CM338 600mg, SC CM338 600mg, single dose, SC Placebo Placebo Placebo, single dose, IV or SC CM338 480mg, IV CM338 480mg, single dose, IV CM338 600mg, IV CM338 600mg, single dose, IV
- Primary Outcome Measures
Name Time Method Safety : Incidence of Adverse Events (AEs). Baseline up to Day 57 Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
- Secondary Outcome Measures
Name Time Method Pharmacokinetics (PK) parameter : Clearance rate (CL/F) Baseline up to Day 57 Clearance rate (CL/F)
Pharmacodynamics (PD) : C4b deposition activity of mannose-binding lectin serine protease 2 (MASP-2) in serum. Baseline up to Day 57 C4b deposition activity of mannose-binding lectin serine protease 2 (MASP-2) in serum.
Bioavailability : bioavailability of CM338 with SC Baseline up to Day 57 The bioavailability of CM338 with SC
Pharmacodynamics (PD) : the content of mannose-binding lectin serine protease 2 (MASP-2) in serum. Baseline up to Day 57 The content of mannose-binding lectin serine protease 2 (MASP-2) in serum.
Immunogenicity: Proportion of subjects with anti-drug antibody (ADA). Baseline up to Day 57 Proportion of subjects with anti-drug antibody (ADA).
Pharmacokinetics (PK) parameter : Peak Plasma concentration (Cmax) Baseline up to Day 57 Peak Plasma concentration (Cmax)
Pharmacokinetics (PK) parameter : Time to reach peak concentration (Tmax) Baseline up to Day 57 Time to reach peak concentration (Tmax)
Pharmacokinetics (PK) parameter : Area under the plasma concentration-time curve from 0 to ∞ (AUC0-∞) Baseline up to Day 57 Area under the plasma concentration-time curve from 0 to ∞ (AUC0-∞)
Pharmacokinetics (PK) parameter : Area under the plasma concentration-time curve from 0 to t (AUC0-t) Baseline up to Day 57 Area under the plasma concentration-time curve from 0 to t (AUC0-t)
Trial Locations
- Locations (1)
PKUCare Luzhong Hospital
🇨🇳Zibo, Shandong, China