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Due to the company's development strategy adjustment, Innovant Biologics decided not to continue this study after consultation with investigators.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI314 | Experimental | Low/medium/high dose, intravenously, once, on Day 1 |
|
| Placebo | Placebo Comparator | Placebo, intravenously, once, on Day 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI314(low dose) | Biological | intravenously, once, on Day 1 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| maximum concentration (Cmax) | PK parameters to be evaluated for IBI314 including maximum concentration (Cmax) will be determined when appropriate. | 29 days after the last participant is randomized |
| area under the concentration-time curve (AUC) |
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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).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | 510260 | China |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000721987 | P5-22 and P14-44 drug combination |
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Masking participant and Investigator
| IBI314(high dose) |
| Biological |
intravenously, once, on Day 1 |
|
| IBI314(medium dose) | Biological | intravenously, once, on Day 1 |
|
| Placebo | Other | intravenously, once, on Day 1 |
|
PK parameters to be evaluated for IBI314 including area under the concentration-time curve (AUC) will be determined when appropriate.
| 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. | 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. | 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. | 29 days after the last participant is randomized |
| The incidence of anti-IBI314 antibody (ADA) and neutralizing antibody (NAb) in serum before and after study drug administration | Each patient will be tested for anti-drug (IBI314) antibody (ADA), and ADA-positive serum samples will continue to be tested for neutralizing antibodies (NAb). | 29 days after the last participant is randomized |
| Time to alleviation of symptoms (going to mild or absent) | This is a clinical efficacy outcome measure. | 29 days after the last participant is randomized |
| Proportion of patients with all-cause mortality by Day 29 | This is a clinical efficacy outcome measure. | 29 days after the last participant is randomized |
| Time to negative RT-qPCR in NP swab samples with no subsequent positive RT-qPCR | This is a virologic efficacy outcome measure. | 29 days after the last participant is randomized |
| Change from baseline in viral shedding on Day 7, 11, 22 | This is a virologic efficacy outcome measure. | 7, 11, 22 days after the last participant is randomized |
| Time-weighted average change in viral shedding from baseline through D11 as measured by RT-qPCR in NP swab samples | This is a virologic efficacy outcome measure. | 11 days after the last participant is randomized |
| Time-weighted average change in viral shedding from baseline through D22 as measured by RT-qPCR in NP swab samples. | This is a virologic efficacy outcome measure. | 22 days after the last participant is randomized |
| Proportion of patients demonstrating symptoms alleviation on D3, 7, 15, 22, 29 | This is a clinical efficacy outcome measure. | 3, 7, 15, 22, 29 days after the last participant is randomized |
| Proportion of patients who become severe COVID-19 by Day 29 | This is a clinical efficacy outcome measure. | 29 days after the last participant is randomized |
| Proportion of patients requiring mechanical ventilation by day 29 | This is a clinical efficacy outcome measure. | 29 days after the last participant is randomized |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |