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

NCT05172141 | Terminated Phase 1

• 1 other identifier: CIBI314B201
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

Brief Summary

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

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 (15)

• 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

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

Biological: IBI314(low dose); Biological: IBI314(high dose); Biological: IBI314(medium dose)

Placebo

PLACEBO COMPARATOR

Placebo, intravenously, once, on Day 1

Other: Placebo

Interventions

IBI314(low dose) BIOLOGICAL

intravenously, once, on Day 1

IBI314

IBI314(high dose) BIOLOGICAL

intravenously, once, on Day 1

IBI314

IBI314(medium dose) BIOLOGICAL

intravenously, once, on Day 1

IBI314

Placebo OTHER

intravenously, once, on Day 1

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• 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 6 months 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:

• 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).

Sponsors & Collaborators

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

Study Sites (1)

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

Location

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
• Masking Details: Masking participant and Investigator
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2021
• First Posted: December 29, 2021
• Study Start: December 31, 2021
• Primary Completion: August 31, 2022
• Study Completion: January 31, 2023
• Last Updated: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)