A phase Ib study of inhaled IN-006 (regdanvimab for nebulization) versus intravenous regdanvimab
- Conditions
- SARS-COV-2Infections and Infestations
- Registration Number
- ISRCTN90678104
- Lead Sponsor
- Inhalon Biopharma Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 48
1. Healthy male and female volunteers, aged 18-55 years, inclusive at the time of signing the informed consent
2. Non-smoker or light smoker (on average =10 cigarettes or = 100 puffs from e-cigarettes per week as judged by the Investigator), and agrees to abstain during the in-patient period, and to use no more nicotine-containing products than the equivalent of smoking 10 cigarettes per week through study exit
3. In good health, as determined by the investigator after reviewing history, physical examination, vital signs, and laboratory tests within normal limits or deemed by the investigator to not be clinically significant
4. Negative serology for HBsAg, HCV antibodies, & HIV antibodies (however positive HCV serology is not an exclusion if negative for HCV RNA)
5. Willingness to comply with the protocol, including nasal swabs, bronchoscopy procedures, and follow-up visits
6. Able to successfully complete a trial saline nebulization treatment (Groups 2 and 3 only)
7. Women of childbearing potential, as defined in Clinical Trials Facilitation and Coordination Group 2020, must have a negative pregnancy test at Screening and agree to abstinence or the use of at least one highly effective form of contraception (with a failure rate of <1% per year when used consistently and correctly):
7.1. Combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation: Oral, Intravaginal, Transdermal
7.2. Progestogen-only hormonal contraception associated with inhibition of ovulation: Oral, Injectable, Implantable
7.3. Intrauterine device
7.4. Intrauterine hormone-releasing system
7.5. Bilateral tubal occlusion or tubal ligation
7.6. Vasectomized partner with confirmed azoospermia
Highly effective contraception or abstinence must be started at least 28 days before the first dose, continue for the duration of the study, and for at least 90 days after the last dose of the study drug.
All females will be considered of childbearing potential unless they are postmenopausal or have been permanently sterilized surgically (e.g., hysterectomy, bilateral salpingectomy, bilateral oophorectomy).
8. Males who are sexually active with women of childbearing potential who have not had a vasectomy must agree to use a barrier method of birth control during the study and for at least 90 days after the last dose of the study drug. Males must also refrain from sperm donations during this time period. Males who are abstinent will not be required to use a contraceptive method unless they become sexually active. Males who have undergone a vasectomy are not required to use a contraceptive method if at least 16 weeks post-procedure.
9. Body mass index (BMI) 18.0 – 32.0 (kg/m2) at the screening visit
10. Forced expiratory volume in 1 second (FEV1) = 80% of predicted at the screening visit and Day -1
11. Electrocardiogram without clinically relevant abnormalities at Screening
12. Clinical laboratory test results within normal limits or judged by the investigator to be not clinically significant within 7 days of or upon admission
13. Total neutrophil count within normal limits or considered to be non-clinically significant (repeat test is allowed if out of range) within 7 days of or upon admission
14. Negative for SARS-CoV-2 on RT-PCR or lateral flow test by nasal swab on Day -1 prior to admission to the inpatient unit
15. Has not received a COVID-19 vaccination or booster for 2 weeks prior to dosing on Day 1 and willing to defer rece
1. Known or suspected symptomatic viral infection within 14 days of dosing initiation
2. Signs of active pulmonary infection or pulmonary inflammatory condition within 14 days of dosing
3. Loss of more than 400 mL of blood within 90 days of first dose, e.g., as a blood donor
4. History of hypersensitivity or allergies to a biologic drug or a constituent of the study drug
5. History of airway hyperresponsiveness (however, a history of resolved childhood asthma is not an exclusion)
6. History of angioedema or anaphylaxis
7. Currently active allergic rhinitis requiring inhaled medication or allergic dermatitis currently requiring medication
8. A positive alcohol breathalyzer or urine test and/or a positive blood or urine drug screen for substances of abuse at screening or upon
admission to the clinical research unit
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method