A Study to Evaluate the Safety Tolerability and Pharmacokinetics of Orally Inhaled Aerosolized Hydroxychloroquine Sulfate in Healthy Adult Volunteers

STATUS

Recruiting
participants needed

16
sponsor

Pulmoquine Therapeutics, Inc

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Updated on 19 February 2024

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body mass index

hysterectomy

chronic disease

bilateral oophorectomy

oximetry

immunodeficiency

chloroquine

oropharyngeal

hydroxychloroquine

pulse oximetry

nasopharyngeal swab

12 lead electrocardiogram

oral contraceptives

Summary

This study is 'A Randomized Phase 1 Double Blind Placebo Controlled, Single-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Orally Inhaled Aerosolized Hydroxychloroquine Sulfate in Healthy Adult Volunteers.' The primary objectives are as follows:

To assess the safety and tolerability of AHCQ administered as a single dose by oral inhalation in healthy individuals at escalating doses until either the maximum tolerated dose (MTD) is identified or 1 mL of a 50 mg/mL solution is administered.
To determine the recommended Phase 2a dose (RP2D).

Secondary objectives:

To characterize pharmacokinetics (PK) of single dose AHCQ in healthy individuals.

Description

Study Design:

This is a randomized, double-blind placebo-controlled Phase 1 single-dose dose-escalation study to assess the safety, tolerability and PK of oral inhalation of AHCQ in healthy participants.

Escalating single doses of AHCQ will be studied in healthy participants. The study drug will be administered by inhalation through the mouth, and participants will be encouraged to exhale through the nose. The study drug, AHCQ, will be administered starting at an initial dose of 20 mg (Cohort A1, 1 mL of 20 mg/mL AHCQ solution) with a proposed subsequent doses of 50 mg (Cohort A2, 1 mL of 50 mg/mL AHCQ).

Number of Participants (Planned):

Two dose levels are planned to be evaluated. Each cohort will comprise 8 participants (6 active, 2 placebo). Therefore, 16 participants will initially be planned to be enrolled in the study. Additional participants may be enrolled if one or more enrolled participants do not complete the study.

Details

Condition	Severe Acute Respiratory Syndrome Coronavirus 2
Age	18years - 100years
Treatment	Placebo, Aerolized Hydroxychloroquine Sulfate
Clinical Study Identifier	NCT04461353
Sponsor	Pulmoquine Therapeutics, Inc
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Willing and able to give written informed consent
	Males or females aged 18 years old
	Good general health as determined by no acute illness and no clinically significant abnormal findings on medical history, vital signs, laboratory tests, or physical examination at screening that, in the opinion of the PI, would interfere with study drug administration, jeopardize the safety of the study participant, or impact the validity of the study results; participants with stable chronic illness are allowed at the discretion of the PI
	An interpretable 12-lead ECG with a corrected QT (QTc) interval 450 ms, according to Bazett's formula, without evidence of clinically significant abnormal findings
	Normal FEV1/FVC ratio, defined as any value above 0.7 or above the lower 5th percentile of normal AND FEV1 >80% of predicted or above the lower 5th percentile of normal
	Pulse oximetry 02 saturation 95% in room air
	Negative test result for COVID-19 within 7 days of Day 1 AND concurrent with local hospital policy
	A nasopharyngeal swab tested with the ID NOW COVID-19 assay (Abbot). OR
	A negative RNA-based test result of an oropharyngeal or nasopharyngeal swab or saliva sample performed according to CLIA/CLEP
	Females of child-bearing potential must be non-pregnant, non-lactating, have a negative urine pregnancy test at screening, and agree to use an acceptable form of birth control for 200 days after the last administration of the study drug. Females are considered of non-childbearing potential if they are postmenopausal (last menstrual period at least 1 year before screening) or have been surgically sterilized (documented hysterectomy, tubal ligation, or bilateral oophorectomy) for at least 6 months at screening
	Willing to comply with protocol-defined procedures and complete all study visits
	Willing to use the Inhalation System and exhale through the nose
	Adequate venous access in the left or right arm to allow collection of required blood samples
	Participant understands and communicates in English
	Serum Potassium level 3.5 mEq/L, Serum Magnesium level 1.5 mg/dL, and Serum Calcium 8.5 mg/dL
Exclusion Criteria
	Any self-reported symptoms of influenza-like or COVID-19-like illness in the 14 days preceding the study visit: Fever >101.4 F, sore throat, nasal congestion, post-nasal discharge, shortness of breath, gastrointestinal distress, wheezing, cough, headache, or fatigue
	Any history of diagnosed chronic lung disease, including but not limited to asthma or chronic obstructive lung disease
	Symptoms of seasonal allergies or use of any drugs for seasonal allergies or any inhaled (oral/nasal) drugs in the 2 weeks prior to Day 1. Mild seasonal allergy symptoms that have not altered sleep or activity patterns nor required use of over-the-counter (OTC) or prescription medications are allowed
	Any close contact exposure in the past 28 days to a person who was diagnosed as having COVID-19, with or without laboratory confirmation, during that close contact exposure or in the ensuing 14 days OR a similar encounter with a person who was determined to have suspected COVID-19, defined by that person being ordered to enter isolation for that indication by a medical authority. Close contact is defined as being within approximately 6 feet of a COVID-19 case for a prolonged (>10 minutes) period of time and can occur while caring for, living with, visiting, or sharing a healthcare waiting area or room with a COVID-19 patient OR having direct contact with infectious secretions of a COVID-19 patient (e.g., being coughed on), if such contact occurred while not wearing the recommended personal protective equipment for that type of contact [e.g., gowns, gloves, N95 respirator (or equivalent), eye protection]
	Any participant with a history of SARS-CoV-2 infection that was confirmed by testing or diagnosed without testing within 4 weeks preceding Day 1. If infection occurred more than 4 weeks prior, candidates may be enrolled if they meet the rest of the eligibility criteria
	Any participant with a history severe respiratory illness that required hospitalization in the 60 days preceding Day 1 OR any participant with a history severe respiratory illness that required hospitalization in the preceding 120 days without full recovery
	Participation in another clinical study that involved treatment with an investigational product or device within 30 days of screening or during the study
	Participants with a known history of human immunodeficiency virus (HIV) infection
	Known, active hepatitis A, B, or C infection
	History of bronchospasm in response to use of an inhalation device
	Use of any prescription medication (except oral contraceptives) during the 30 days prior to study dosing that may affect drug absorption, metabolism and excretion, prolong the QTc interval, affect drug efficacy, or increase the risk of adverse reactions, unless approved by the Principal Investigator
	Use of any OTC product, herbal product, diet aid, hormone supplement, etc., within 7 days prior to dosing unless approved by the Principal Investigator
	Unwilling or unable to provide written informed consent
	Any known hypersensitivity to quinolines (e.g., hydroxychloroquine, chloroquine, primaquine, quinine) or known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency or any contraindication to oral hydroxychloroquine
	Known retinopathy, fundus disease, or macular disease
	Diagnosis of long QT Syndrome
	Smoking of tobacco or non-tobacco substances, or vaping, within the last 6 months
	Severe obesity (body mass index [BMI] 35 kg/m2)

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Study Definition

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A Study to Evaluate the Safety Tolerability and Pharmacokinetics of Orally Inhaled Aerosolized Hydroxychloroquine Sulfate in Healthy Adult Volunteers