## Protocol Section
### Identification Module
**NCT ID:** NCT06416787

**Brief Title:** Safety and Tolerability of IBI355 in Healthy Volunteers

**Official Title:** A Double Blind, Randomized Study Assessing the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Doses of IBI355 in Healthy Voluteers

#### Organization Study ID Info
**ID:** CIBI355A103
#### Organization
**Class:** INDUSTRY
**Full Name:** Innovent Biologics (Suzhou) Co. Ltd.
### Status Module
#### Completion Date
**Date:** 2025-12-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-02-13

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-17

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-11
**Study First Submit QC Date:** 2024-05-15
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Innovent Biologics (Suzhou) 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 aims to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of IBI355 in Healthy voluteers. This study also aims to evaluate the anti-Drug antibody after multiple ascending doses of IBI355 in Healthy voluteers.

### Conditions Module

**Conditions:**

- Healthy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 32

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** IBI355 15mg/kg and placebo will be given to the subjects every 4 weeks (6:2)

**Intervention Names:**

- Drug: placebo

- Drug: IBI355

**Label:** IBI355 dose-3

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** IBI355 1mg/kg and placebo will be given to the subjects every 4 weeks (6:2)

**Intervention Names:**

- Drug: placebo

- Drug: IBI355

**Label:** IBI355 dose-1

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** IBI355 30mg/kg and placebo will be given to the subjects every 4 weeks (6:2)

**Intervention Names:**

- Drug: placebo

- Drug: IBI355

**Label:** IBI355 dose-4

**Type:** EXPERIMENTAL

#### Arm Group 4

**Description:** IBI355 7.5mg/kg and placebo will be given to the subjects every 4 weeks (6:2)

**Intervention Names:**

- Drug: placebo

- Drug: IBI355

**Label:** IBI355 dose-2

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- IBI355 dose-1

- IBI355 dose-2

- IBI355 dose-3

- IBI355 dose-4

**Description:** IBI355 7.5mg/kg Q4W

**Name:** placebo

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- IBI355 dose-1

- IBI355 dose-2

- IBI355 dose-3

- IBI355 dose-4

**Description:** IBI355 1mg/kg Q4W

**Name:** IBI355

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Incidence of adverse events and serious adverse events

**Time Frame:** Up to week 24

#### Secondary Outcomes

**Measure:** Area under the Curve(AUC) of multi-dose of IBI355

**Time Frame:** Up to week 12

**Measure:** Peak serum concentration(Cmax) of multi-dose of IBI355

**Time Frame:** Up to week 12

**Measure:** Clearance (CL) of multi-dose of IBI355

**Time Frame:** Up to week 12

**Measure:** Half-life (t1/2) of multi-dose of IBI355

**Time Frame:** Up to week 12

**Measure:** The ratio of Anti-drug antibody of multi-dose of IBI355

**Time Frame:** Up to week 24

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Understanding and Signing a written informed consent prior to selection;
2. Aged above 18 years old, male or female;
3. Body mass index (BMI) between 18-28kg/m2;
4. Normal lable test;
5. No parenting plan for at least 6 months

Exclusion Criteria:

1. Subjects with a history of allergy；
2. Subjects paticipated in the other clinical trail in 1 month or less than 5 t1/2 since the previous clinical trial (which is longer)；
3. Subjects with an infection requiring systemic medication was present within 30 days prior to randomization;
4. HIV-Ab、RPR、HCV-Ab、HBV、HBeAg or HBcAb, one of them positive;
5. There have a clinical or imaging evidence that the subject with active tuberculosis, or there is evidence that the subject is in the incubation period for tuberculosis;
6. Patients with a history of central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic disorders and other systemic diseases;
7. Subject with a hcg positive;
8. Patients with a history of neuropsychiatry or who are considered unfit to participate in this clinical trial

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** yang.yu@innoventbio.com

**Name:** Yang Yu

**Phone:** 0512-69566088

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Beijing

**Contacts:**

***Contact 1:***

- **Email:** wjlsq@sina.com

- **Name:** Jin Wang

- **Phone:** 010-59971772

- **Role:** CONTACT

**Country:** China

**Facility:** Aerospace Center Hospital

**State:** Beijing

**Zip:** 100049

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
