Phase 1 Study to Assess Safety, Tolerability, PD, PK, Immunogenicity of IV NTR-441 Solution in Healthy Volunteers and COVID-19 Patients
Study Details
Study Description
Brief Summary
This first-in-human clinical study is a Phase 1a/ 1b, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, and PK/PD of NTR-441 in healthy subjects and patients with COVID-19 after single ascending IV infusion doses and multiple ascending IV infusion doses.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: NTR-441 Single Ascending Dose; Multiple Ascending Dose. |
Drug: NTR-441
NTR-441
|
| Placebo Comparator: Placebo Single Ascending Dose; Multiple Ascending Dose. |
Drug: Placebo
Placebo
|
Outcome Measures
Primary Outcome Measures
- To evaluate safety and tolerability of single and multiple ascending doses of NTR-441 solution administered intravenously (IV) to adults [60 days]
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 following a single or multiple IV of NTR-441.
Secondary Outcome Measures
- Measurement of maximum plasma concentration (Cmax) [15 days]
Maximum plasma concentration
- Measurement of time of maximum plasma concentration (Tmax) [14 days]
Time of maximum plasma concentration
- Measurement of area under the concentration-time curve [15 days]
Area under the concentration-time curve from predose to the time of the last quantifiable concentration
- Measurement of the terminal elimination rate (λz) [15 days]
Terminal elimination rate
- Measurement of terminal elimination half-life (t½) [15 days]
Terminal elimination half-life
- Measurement of total body clearance (CL/F) [15 days]
Total body clearance
- Measurement of apparent volume of distribution [15 days]
Apparent volume of distribution
- To assess for immunogenicity of NTR-441 following single ascending and multiples ascending doses of NTR-441 solution administered IV to adults [30 days]
Concentration of anti-drug antibodies of NTR-441 following single and multiples doses of NTR-441 solution administered IV
Eligibility Criteria
Criteria
Healthy volunteers:
Inclusion Criteria:
-
Male or female, non-smoker, ≥18 and ≤55 years of age, with Body Mass Index (BMI) > 18.5 and < 32.0 kg/m2
-
Healthy with no clinically significant findings, determined by medical evaluation (medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations) at Screening
-
Subject is able to understand and is willing to comply with all study requirements, and willing to follow the instructions of the study staff.
-
Subject voluntarily agrees to participate in this study.
Exclusion Criteria:
-
Pregnancy, nursing, and/or breastfeeding.
-
Study participant has a history of an anaphylactic reaction.
-
Subject has used an investigational drug within 30 days (or 5 half-lives whichever is longer) prior to the first dose of study drug.
-
Has received any prescription or nonprescription over-the-counter (except occasional use of acetaminophen, paracetamol or ibuprofen) medication, topical medications, vitamins, dietary or herbal during the last 14 days or 5 half-lives, whichever is longer.
-
Subject has a positive urine test for drugs of abuse at the screening visit or admission.
-
Regular consumption of alcohol within 6 months prior to Screening or use of illicit substances within 3 months prior to screening.
-
Subject has positive test for SARS-CoV-2 infection, human immunodeficiency virus (HIV), chronic or active hepatitis B, or active hepatitis C.
-
Donation or loss of blood or plasma within 4 weeks prior to initial dosing.
-
Subject has a history or current evidence of a serious and/or unstable cardiovascular, respiratory, gastrointestinal, hematologic, autoimmune, mental or other medical disorder, including cirrhosis or malignancy; a history of a psychiatric disorder that will affect the subject's ability to participate in the study.
-
Subject has a clinically relevant abnormal ECG; abnormal laboratory values.
-
Subject has hypertension.
COVID-19 patients:
Inclusion Criteria:
-
Male or female, non-smoker, ≥18 years of age.
-
Participant has active laboratory-confirmed SARS-CoV-2 infection.
-
Participant must be hospitalized for COVID-19 pneumonia.
-
Ability to provide informed consent personally, or by a legally acceptable representative if the participant is unable to do so.
Exclusion Criteria:
-
Pregnancy, nursing, and/or breastfeeding.
-
History of an anaphylactic reaction.
-
In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments.
-
Severely immune-compromised participants.
-
Participant known to test positive for human immunodeficiency virus (HIV), chronic or active hepatitis B, or active hepatitis C.
-
Any other clinical conditions that in the opinion of the Investigator would make the participants unsuitable for the study.
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Prior treatment with any investigational drug therapy against coronavirus infection within 5 half-lives, prior to enrollment
-
Participants who have received an experimental (or, in future, potentially a licensed) immunization or remdesivir against coronavirus remain eligible.
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Participation in another clinical study with the study intervention administered from 30 days or 5 half-lives whichever is longer.
-
Anticipated transfer to another hospital which is not a study site during the intervention period.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Klinik Favoriten | Vienna | Austria | ||
| 2 | Medical University Vienna, Department of Clinical Pharmacology | Vienna | Austria | ||
| 3 | Kyiv City Clinical Hospital#1 | Kyiv | Ukraine | ||
| 4 | Vinnytsa City Clinical Hospital # 1 | Vinnytsia | Ukraine |
Sponsors and Collaborators
- Neutrolis
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NTR441-1001