A Safety, Tolerability, and Efficacy Study of IBI314 in Ambulatory Patients With COVID-19

NCT05162365 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: CIBI314A201
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 19

Brief Summary

This is a dose-finding, inferentially seamless Phase 1/2 study evaluating the safety, tolerability and efficacy of IBI314 in Ambulatory Patients with COVID-19.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

• Number of treatment related AEs

  Any AEs and SAEs occurring during the study

  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.

  7 days after the last participant is randomized

Secondary Outcomes (14)

• maximum concentration (Cmax)

  29 days after the last participant is randomized

• area under the concentration-time curve (AUC)

  29 days after the last participant is randomized

• half-life (t1/2)

  29 days after the last participant is randomized

• clearance (CL)

  29 days after the last participant is randomized

• volume of distribution (V)

  29 days after the last participant is randomized

Study Arms (2)

IBI314

EXPERIMENTAL

a cocktail of two SARS-CoV-2 S protein IgG1 antibodies, IBI314-A and IBI314-B, in a 1:1 \[w/w\] ratio

Biological: IBI314

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

IBI314 BIOLOGICAL

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

IBI314

Placebo OTHER

Placebo, intravenously, once, on Day 1

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 90 days after the dose of study drug is administered.
• Women of childbearing potential (WOCBP) must have a negative urinary pregnancy test at screening.

You may not qualify if:

• according to protocol v3.0, Note: Patients with mild-to-moderate disease who are placed in a facility where required by local guidelines can be enrolled.
• 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 and mechanical ventilation, oxygen delivered by high-flow nasal cannula noninvasive positive pressure ventilation, extracorporeal membrane oxygenation (ECMO).

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (19)

Sobh

Anaheim, California, 92806, United States

Location

Long Beach Clinical Trials, LLC

Long Beach, California, 90806, United States

Location

Acclaim Clinical Research

San Diego, California, 92120, United States

Location

Herco Research Center, Inc.

Coral Gables, Florida, 33134, United States

Location

Midland Florida Clinical Research Center - Inf. Disease/Infectiology

DeLand, Florida, 32720, United States

Location

Palm Springs Research Institute

Hialeah, Florida, 33012, United States

Location

Sweet Hope Research Specialty, Inc

Hialeah, Florida, 33016, United States

Location

Prestige Clinical Research Center Inc

Miami, Florida, 33133, United States

Location

Cordova Research Institute, LLC

Miami, Florida, 33155, United States

Location

Clinical Trials of Florida, LLC

Miami, Florida, 33186, United States

Location

The Clinical Research Institute LLC

Miami Gardens, Florida, 33169, United States

Location

Pembroke Clinical Trials

Pembroke Pines, Florida, 33028, United States

Location

Luminous Clinical Research LLC - South Florida Urgent Care - Infectious Diseases

Pembroke Pines, Florida, 33029-2818, United States

Location

Palm Beach Research Center

West Palm Beach, Florida, 33409, United States

Location

Florida Pulmonary Research Institute, LLC

Winter Park, Florida, 32789, United States

Location

Excel Clinical Research - Internal Medicine

Las Vegas, Nevada, 89109, United States

Location

Temple University Health System - Temple Lung Center

Philadelphia, Pennsylvania, 19140-5103, United States

Location

Zenos Clinical Research

Dallas, Texas, 75230, United States

Location

Epic Clinical Research

Lewisville, Texas, 75057, United States

Location

Related Publications (1)

• Huang Y, Lin Z, Guo X, Zhang F, Wang Y, Zhang Z, Chen J, Liu L, Zhu M, Li Y, Ni M, Zhen Z, Wu Z, Ling X, Zhou S, Xi Y, Yu Y, Liang W, Zhao J, Li L, He J, Sang L. Development of broadly neutralizing antibodies against Omicron variants from existing neutralizing antibodies in clinical trials. Virol J. 2025 Nov 4;22(1):358. doi: 10.1186/s12985-025-02964-8.

  PMID: 41188882 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

P5-22 and P14-44 drug combination

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2021
• First Posted: December 17, 2021
• Study Start: January 6, 2022
• Primary Completion: June 29, 2022
• Study Completion: November 18, 2022
• Last Updated: December 18, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (19)