Clinical trial NCT05186285: Single Ascending Dose Study of CM338 in Healthy Volunteers
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Keymed Biosciences Co.Ltd
Sponsor class: INDUSTRY
First posted: 2022-01-11
Enrollment: 66
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Safety : Incidence of Adverse Events (AEs).
timeFrame: Baseline up to Day 57
Secondary outcomes:
measure: Pharmacokinetics (PK) parameter : Peak Plasma concentration (Cmax)
timeFrame: Baseline up to Day 57
measure: Pharmacokinetics (PK) parameter : Time to reach peak concentration (Tmax)
timeFrame: Baseline up to Day 57
measure: Pharmacokinetics (PK) parameter : Area under the plasma concentration-time curve from 0 to ∞ (AUC0-∞)
timeFrame: Baseline up to Day 57
measure: Pharmacokinetics (PK) parameter : Area under the plasma concentration-time curve from 0 to t (AUC0-t)
timeFrame: Baseline up to Day 57
measure: Pharmacokinetics (PK) parameter : Clearance rate (CL/F)
timeFrame: Baseline up to Day 57
measure: Bioavailability : bioavailability of CM338 with SC
timeFrame: Baseline up to Day 57
measure: Pharmacodynamics (PD) : C4b deposition activity of mannose-binding lectin serine protease 2 (MASP-2) in serum.
timeFrame: Baseline up to Day 57
measure: Pharmacodynamics (PD) : the content of mannose-binding lectin serine protease 2 (MASP-2) in serum.
timeFrame: Baseline up to Day 57
measure: Immunogenicity: Proportion of subjects with anti-drug antibody (ADA).
timeFrame: Baseline up to Day 57
Other outcomes:
Locations:
city: Zibo
country: China
facility: PKUCare Luzhong Hospital
state: Shandong
Study officials:
References: