## Protocol Section
### Identification Module
**NCT ID:** NCT05371379

**Brief Title:** Multiple Ascending Dose Study of CM338 in Healthy Volunteers

**Official Title:** A Multiple-dose, Randomized, Double Blind, Placebo-controlled, Dose-escalation Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of CM338 Injection in Healthy Subjects

#### Organization Study ID Info
**ID:** CM338-100002
#### Organization
**Class:** INDUSTRY
**Full Name:** Keymed Biosciences Co.Ltd
### Status Module
#### Completion Date
**Date:** 2022-06-01

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2022-05-12

**Type:** ACTUAL

**Last Update Submit Date:** 2022-05-07

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2022-06-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2022-05

#### Study First Post Date
**Date:** 2022-05-12
**Type:** ACTUAL
**Study First Submit Date:** 2022-05-07
**Study First Submit QC Date:** 2022-05-07
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Keymed Biosciences Co.Ltd

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This study was a multi-center, randomized, double blind, placebo-controlled, single-dose, dose escalation Phase I study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM338 with multiple dosing in healthy subjects.

**Detailed Description:** The study included screening period, administration and safety follow-up period.

Forty-eight healthy volunteers will be enrolled and randomized into 4 groups.

### Conditions Module

**Conditions:**

- Healthy Subjects

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** SEQUENTIAL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 48

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Qquaque week

**Intervention Names:**

- Biological: CM338 Injection

**Label:** CM338 75 mg, subcutaneous injection

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Qquaque week

**Intervention Names:**

- Biological: CM338 Injection

**Label:** CM338 150 mg, subcutaneous injection

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** Qquaque week

**Intervention Names:**

- Biological: CM338 Injection

**Label:** CM338 300 mg, subcutaneous injection

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** Qquaque week

**Intervention Names:**

- Biological: CM338 Injection

**Label:** CM338 300 mg, intravenous infusion

**Type:** EXPERIMENTAL

#### Arm Group 5

**Description:** placebo

**Intervention Names:**

- Biological: CM338 Injection

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- CM338 150 mg, subcutaneous injection

- CM338 300 mg, intravenous infusion

- CM338 300 mg, subcutaneous injection

- CM338 75 mg, subcutaneous injection

- Placebo

**Description:** A humanized monoclonal antibody.

**Name:** CM338 Injection

**Type:** BIOLOGICAL

### Outcomes Module

#### Primary Outcomes

**Description:** Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.

**Measure:** Incidence of Adverse Events (AEs).

**Time Frame:** Up to Week 12.

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Healthy male volunteers, aged ≥18 and ≤65 years.
* Medical history, vital signs, physical examination, 12-lead ECG, X-ray, and abdominal color ultrasound results are normal, or abnormal without clinically significance.
* All clinical laboratory examination are normal, or abnormal without clinical significance.

Exclusion Criteria:

* Take any prescription medicine within 2 weeks before administration, or take any Chinese medicine or non-prescription medicine within 1 week.
* Live attenuated vaccine was administered within 30 days prior to administration or planned to vaccinate during the study period.
* Major surgery will be planned during the study period, or major surgery was performed within 4 weeks prior to dosing.
* Any blood loss greater than 400 mL by voluntary blood donation or in any other manner within 4 weeks prior to administration.

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** MALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M4225

- Name: Antibodies

- Relevance: LOW

- As Found: Unknown

- ID: M4230

- Name: Antibodies, Monoclonal

- Relevance: LOW

- As Found: Unknown

- ID: M10184

- Name: Immunoglobulins

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
