COVID-19 trials registries data warehouse

https://anzctr.org.au/ACTRN12621001235897.aspx

Dr Jason Lickliter

j.lickliter@nucleusnetwork.com.au

2021-09-13

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Prevention

1. Male and female, age 18-55 years, inclusive. 2. Non-smoker or smokes on average less than or equal to 10 cigarettes per week 3. Woman participants must be non-pregnant and either surgically sterile, use an acceptable contraceptive method, or be post-menopausal 4. Male participants must be surgically sterile, abstinent, or if engaged in sexual relations with a WOCBP, the partner must be surgically sterile or using an acceptable contraceptive method 5. Negative SARS-CoV-2 RT-PCR nasal swab during screening period

1. Known or suspected symptomatic viral infection within 14 days of dosing initiation. 2. Signs of active pulmonary infection or pulmonary inflammatory conditions within 14 days of dosing. 3. History of hypersensitivity or allergies to a biologic drug or a constituent of the study drug or placebo. 4. History of previous administration of a monoclonal antibody or any inhaled biologic. 5. History of vaccination against SARS-CoV-2. 6. History of atopy or airway hyperresponsiveness.

2

Inhalon Biopharma; Inc.

18

55

Australia

Healthy volunteers

N/A

24

The primary objective is to evaluate the safety and tolerability of nebulized IN-006 in healthy volunteers following a single dose of IN-006.Safety and tolerability assessments will include vital signs (including FEV1 and SpO2); safety labs; ECG; and physical exams.[Vital signs including FEV1 and SpO2 will be collected at:Screening; Day -1 (the day prior to dosing); Dosing Day 1; Day 2 at 24 hours post-dose; Day 4 (72 hr); Day 6 (120 hr); Day 8 (168 hr); Day 15; and Day 29 (End Of Study [EOS]). Vitals signs will be measured by an automated blood pressure machine. FEV1 will be measured by standard spirometry and SpO2 will be measured by a pulse oximeter.Safety labs will be collected at:Screening; Day -1 (the day prior to dosing); and post-dose on Day 2 (24 hours post-dose); Day 8 (168 hrs); and Day 29 (EOS).ECGs will be collected at Screening; Day -1 (the day prior to dosing); Day 2 (24 hours post-dose); and Day 29 (EOS);Complete physical exams will be completed at Screening; Day 2 (24 hours post-dose); and Day 29 (EOS); Symptom-directed exams may be conducted at any other time at the discretion of the investigator.];The primary objective is to evaluate the safety and tolerability of nebulized IN-006 in healthy volunteers following multiple doses of IN-006.Safety and tolerability assessments will include vital signs (including FEV1 and SpO2); safety labs; ECG; and physical exams.[Vital signs including FEV1 and SpO2 will be collected at:Screening; Day -1 (the day prior to dosing); Dosing Days 1 through 7; Day 8; Day 15; and Day 29 (EOS). Vitals signs will be measured by an automated blood pressure machine. FEV1 will be measured by standard spirometry and SpO2 will be measured by a pulse oximeter.Safety labs will be collected at:Screening; Day -1; and post-dose on Day 4 (72 hrs); Day 8 (168 hrs); Day 15; and Day 29.ECGs will be collected at Screening; Day -1 (the day prior to dosing); and post-dose on Day 8; and Day 29 (EOS);Complete physical exams will be completed at Screening; Day 8; and Day 29 (EOS); Symptom-directed exams may be conducted at any other time at the discretion of the investigator]

Phase 1

[{"arm_notes": "", "treatment_id": 1912, "treatment_name": "Regdanvimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]