Healthy
Conditions
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.
Interventions
DRUGCM338
CM338 : a humanized monoclonal antibody.
DRUGPlacebo
Placebo.
Sponsors
Keymed Biosciences Co.Ltd
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Pharmacokinetics (PK) parameter : Clearance rate (CL/F) | Baseline up to Day 57 | Clearance rate (CL/F) |
| Pharmacokinetics (PK) parameter : Peak Plasma concentration (Cmax) | Baseline up to Day 57 | Peak Plasma concentration (Cmax) |
| 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. |
| 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). |
| Bioavailability : bioavailability of CM338 with SC | Baseline up to Day 57 | The bioavailability of CM338 with SC |
Countries
China
Outcome results
None listed