A Single-dose, Randomized, Double Blind, Placebo-controlled, Dose-increasing Study to Evaluate the Safety, Tolerability, PK Characteristics, PD Effect, and Immunogenicity of CM338 Injection in Healthy Subjects.
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Safety : Incidence of Adverse Events (AEs).
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Male
- Accepts 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.
Arms & Interventions
CM338 30mg, IV
30mg, single dose, IV
Intervention: CM338 (Drug)
CM338 60mg, IV
60mg, single dose, IV
Intervention: CM338 (Drug)
CM338 120mg, IV
120mg, single dose, IV
Intervention: CM338 (Drug)
CM338 240mg, IV
240mg, single dose, IV
Intervention: CM338 (Drug)
CM338 240mg, SC
240mg, single dose, SC
Intervention: CM338 (Drug)
CM338 480mg, IV
480mg, single dose, IV
Intervention: CM338 (Drug)
CM338 600mg, IV
600mg, single dose, IV
Intervention: CM338 (Drug)
CM338 600mg, SC
600mg, single dose, SC
Intervention: CM338 (Drug)
Placebo
Placebo, single dose, IV or SC
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Safety : Incidence of Adverse Events (AEs).
Time Frame: Baseline up to Day 57
Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
Secondary Outcomes
- Pharmacokinetics (PK) parameter : Clearance rate (CL/F)(Baseline up to Day 57)
- Pharmacodynamics (PD) : C4b deposition activity of mannose-binding lectin serine protease 2 (MASP-2) in serum.(Baseline up to Day 57)
- Bioavailability : bioavailability of CM338 with SC(Baseline up to Day 57)
- Pharmacodynamics (PD) : the content of mannose-binding lectin serine protease 2 (MASP-2) in serum.(Baseline up to Day 57)
- Immunogenicity: Proportion of subjects with anti-drug antibody (ADA).(Baseline up to Day 57)
- Pharmacokinetics (PK) parameter : Peak Plasma concentration (Cmax)(Baseline up to Day 57)
- Pharmacokinetics (PK) parameter : Time to reach peak concentration (Tmax)(Baseline up to Day 57)
- Pharmacokinetics (PK) parameter : Area under the plasma concentration-time curve from 0 to ∞ (AUC0-∞)(Baseline up to Day 57)
- Pharmacokinetics (PK) parameter : Area under the plasma concentration-time curve from 0 to t (AUC0-t)(Baseline up to Day 57)