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

NCT04461353 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2020-10-08

No results posted yet for this study

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.

Conditions

  • Severe Acute Respiratory Syndrome Coronavirus 2

Interventions

DRUG

Aerolized Hydroxychloroquine Sulfate

sterile AHCQ 100 mg/mL for inhalation, is a clear solution packaged in clear glass vials and stored at room temperature.

OTHER

Placebo

The placebo product and diluent solution is sodium chloride inhalation solution, United States Pharmacopeia (USP) 0.9%.

Sponsors & Collaborators

  • Rockefeller University

    collaborator OTHER

  • Pulmoquine Therapeutics, Inc

    lead INDUSTRY

Principal Investigators

  • Ohad S Bentur, MD, MHA · Rockefeller University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-25
Primary Completion
2020-08-17
Completion
2020-08-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04461353 on ClinicalTrials.gov