NCT04461353

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

Completed Phase 1 Last updated 8 October 2020

What this trial tests

Phase 1 trial testing Aerolized Hydroxychloroquine Sulfate in Severe Acute Respiratory Syndrome Coronavirus 2 in 12 participants. Completed in 17 August 2020.

Timeline

25 June 2020

Primary endpoint
17 August 2020

17 August 2020

Quick facts

Lead sponsor	Pulmoquine Therapeutics, Inc
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	12
Start date	25 June 2020
Primary completion	17 August 2020
Estimated completion	17 August 2020
Sites	1 location across United States

Drugs / interventions tested

• Aerolized Hydroxychloroquine Sulfate — full drug profile →
• Placebo

Conditions studied

• Severe Acute Respiratory Syndrome Coronavirus 2 — all drugs for Severe Acute Respiratory Syndrome Coronavirus 2 →

Sponsor

Pulmoquine Therapeutics, Inc — full company profile →

Who can join

18 and older, any sex, with Severe Acute Respiratory Syndrome Coronavirus 2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Potential therapeutic and pharmacological strategies for SARS-CoV2.
   Ghareeb DA, Saleh SR, Nofal MS, Kaddah MMY, et al · · 2021 · cited 15× · PMID 33688448 · DOI 10.1007/s40005-021-00520-4
2. Repurpose but also (nano)-reformulate! The potential role of nanomedicine in the battle against SARS-CoV2.
   Tammam SN, El Safy S, Ramadan S, Arjune S, et al · · 2021 · cited 13× · PMID 34293319 · DOI 10.1016/j.jconrel.2021.07.028
3. Nebulised Isotonic Hydroxychloroquine Aerosols for Potential Treatment of COVID-19.
   Tai W, Chow MYT, Chang RYK, Tang P, et al · · 2021 · cited 10× · PMID 34452220 · DOI 10.3390/pharmaceutics13081260
4. Potential Prophylactic Treatments for COVID-19.
   Ben-Zuk N, Dechtman ID, Henn I, Weiss L, et al · · 2021 · cited 9× · PMID 34372498 · DOI 10.3390/v13071292
5. Scope of repurposed drugs against the potential targets of the latest variants of SARS-CoV-2.
   Niranjan V, Setlur AS, Karunakaran C, Uttarkar A, et al · · 2022 · cited 7× · PMID 35938064 · DOI 10.1007/s11224-022-02020-z
6. Computational proteomics to enhance personalized treatment of COVID-19 and Long COVID.
   Sahu D, Van Nynatten LR, Tweddell D, Daley M, et al · · 2026 · PMID 41947042 · DOI 10.1186/s12014-026-09601-8