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A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of ABBV-47D11 in Adults Hospitalized with COVID-19

A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of ABBV-47D11 in Adults Hospitalized with COVID-19 - M20-404

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON50807
Enrollment
2
Registered
2020-12-21
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronavirus COVID-19

Interventions

Participants will receive single intravenous (into the veins) infusion of ABBV-47D11 or placebo of Day 1.

Sponsors

AbbVie Deutschland GmbH & Co. KG
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Adult, at least 18 years old, weighing at least 45 kg 2. Confirmed SARS-CoV-2 infection based on initial nucleic acid or antigen testing from respiratory swab, saliva, or other bodily fluid within 7 days prior to randomization (note: timing based on date of test result) 3. Must have >= 1 symptom associated with COVID-19 (e.g., fever, chills/sweats, cough, shortness of breath/dyspnea, sore throat, fatigue, dyspnea, myalgia, headache, congestion, gastrointestinal symptoms [nausea, vomiting, diarrhea], new loss of taste or smell) with an onset of

Exclusion criteria

Exclusion criteria: 1. Must not have an oxygen saturation (SpO2)

Design outcomes

Primary

MeasureTime frame
Safety Endpoints (Primary) - up to Day 106 1. Number of Participants With Study-Drug Related Grade 3 or Higher Adverse Events (AEs) 2. Number of Participants With Study-Drug Related Grade 3 or Higher Infusion-Related Reactions—

Secondary

MeasureTime frame
1. Maximum Observed Serum Concentration (Cmax) of ABBV-47D11 up to Day 85 2. Time to Cmax (Tmax) of ABBV-47D11 up to Day 85 3. Area Under the Serum Concentration-Time Curve (AUC) From Day 1 (0 hour) to Day 29 (672 hour) (AUC0-672h) of ABBV-47D11 4. Terminal Phase Elimination Half-Life (t1/2) of ABBV-47D11 up to Day 85 5. AUC From Time 0 to Infinity (AUCinf) of ABBV-47D11 up to Day 85 6. Detection of Anti-Drug Antibodies (ADA) up to Day 85 7. Detection of Neutralizing Anti-Drug Antibodies (nADA) up to Day 85 8. AUC for Change From Baseline (Day 1) in SARS-CoV-2 Ribose Nucleic Acid (RNA) Reverse Transcription-Polymerase Chain Reaction (RT-PCR) through Day 29 9. Time to Negative SARS-CoV-2 by RT-PCR up to Day 29 10. Negative SARS-CoV-2 RNA by RT-PCR up to Day 15—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)