A Safety, Tolerability, and Efficacy Study of IBI314 in Patients With Mild to Moderate COVID-19

NCT ID: NCT05172141

Last Updated: 2023-03-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 222 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-31
• Study Completion Date: 2023-01-31

Brief Summary

This is a Phase 1/2 study evaluating the safety, tolerability and efficacy of IBI314.

Detailed Description

Phase 1 is a randomized, double-blind, placebo-controlled, single ascending dose study in up to 24 health volunteers. This phase of the study is designed to assess the safety, tolerability and PK of IBI314 administered as a single IV infusion. Phase 2 is a randomized, double-blind, placebo-controlled expansion study in approximately 198 mild to moderate adult patients with COVID-19. This phase of the study is designed to assess the efficacy, safety, PK and PD of IBI314.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

IBI314

Low/medium/high dose, intravenously, once, on Day 1

Group Type: EXPERIMENTAL

IBI314(low dose)

Intervention Type: BIOLOGICAL

intravenously, once, on Day 1

IBI314(high dose)

Intervention Type: BIOLOGICAL

intravenously, once, on Day 1

IBI314(medium dose)

Intervention Type: BIOLOGICAL

intravenously, once, on Day 1

Placebo

Placebo, intravenously, once, on Day 1

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

intravenously, once, on Day 1

Interventions

IBI314(low dose)

intravenously, once, on Day 1

Intervention Type: BIOLOGICAL

IBI314(high dose)

intravenously, once, on Day 1

Intervention Type: BIOLOGICAL

IBI314(medium dose)

intravenously, once, on Day 1

Intervention Type: BIOLOGICAL

Placebo

intravenously, once, on Day 1

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

First onset of COVID-19 symptoms <7 days at randomization, symptoms such as fever and/or chills, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, and diarrhea.

Have a positive SARS-CoV-2 Reverse Transcription-Polymerase Chain Reaction (RT-PCR) test using an appropriate sample such as nasopharyngeal (NP), nasal, oropharyngeal, or saliva within 72 hours prior to randomization. A historical record of a positive result from a test conducted ≤72 hours prior to randomization is acceptable.

Male or female patients ≥18 years of age at the time of signing informed consent.

Agree to use an adequate method of contraception throughout the study period and for 6 months after the dose of study drug is administered.

Women of childbearing potential (WOCBP) must have a negative urinary pregnancy test at screening.

Exclusion Criteria

Have oxygen saturation (SpO2) ≤93 % on room air at sea level or a ratio of arterial oxygen partial pressure (PaO2 in millimeters of mercury) to fractional inspired oxygen (FiO2) <300, respiratory rate ≥30 per minute, heart rate ≥125 per minute.

Have evidence of multi-organ dysfunction/failure. Systolic blood pressure <90 mmHg, diastolic blood pressure <60 mmHg, or requiring vasopressors.

Require or anticipated impending need for endotracheal intubation, mechanical ventilation, oxygen delivered by high-flow nasal cannula noninvasive positive pressure ventilation, extracorporeal membrane oxygenation (ECMO).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Innovent Biologics (Suzhou) Co. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

CIBI314B201

Identifier Type: -

Identifier Source: org_study_id