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

Phase 2TerminatedNCT05172141

Innovent Biologics (Suzhou) Co. Ltd.222 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

222

Conditions

COVID-19

Interventions

IBI314(low dose)BIOLOGICAL

intravenously, once, on Day 1

IBI314(high dose)BIOLOGICAL

intravenously, once, on Day 1

IBI314(medium dose)BIOLOGICAL

intravenously, once, on Day 1

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Main 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. Main 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).

Locations (1)

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

Number of treatment related AEs

Any AEs and SAEs occurring during the study

Time frame: 29 days after the last participant is randomized

Virologic efficacy Evaluation

Time-weighted average change in viral shedding from baseline through Day 7 as measured by RT-qPCR in NP swab samples

Time frame: 7 days after the last participant is randomized

Secondary Outcomes

maximum concentration (Cmax)

PK parameters to be evaluated for IBI314 including maximum concentration (Cmax) will be determined when appropriate.

Time frame: 29 days after the last participant is randomized

area under the concentration-time curve (AUC)

PK parameters to be evaluated for IBI314 including area under the concentration-time curve (AUC) will be determined when appropriate.

Time frame: 29 days after the last participant is randomized

half-life (t1/2)

PK parameters to be evaluated for IBI314 including half-life (t1/2) will be determined when appropriate.

Time frame: 29 days after the last participant is randomized

clearance (CL)

PK parameters to be evaluated for IBI314 including clearance (CL) will be determined when appropriate.

Time frame: 29 days after the last participant is randomized

volume of distribution (V)

PK parameters to be evaluated for IBI314 including volume of distribution (V) will be determined when appropriate.

Time frame: 29 days after the last participant is randomized

Data from ClinicalTrials.gov

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