Pharmaceutcial giant Pfizer has kicked off a human trial for a Covid-19 pill that the company hopes to make available before the end of the year.
The trial, which is held at Pfizer labs in Belgium and the US, includes 60 clean-living adults aged 18-60 and will last for 145 days, according to various media reports. The final 28 days will reportedly used to get screening and dosing right.
The human trial consists of three phases, with more than 200 Pfizer researchers working full-time on the project.
During the first round, volunteers will be tested and monitored on how well the drug is tolerated, while the next phase will consist of adults taking multiple doses and the final phase evolves around the tolerance of the pill in combination with food intake. The final 28 days will reportedly used to get screening and dosing right.
According to Pfizer documents seen by various news outlets, volunteers did receive a warning that the drugs has so far only been tested on a limited number of animals.
“The safety of the study drug has been studied in animals. In these animal studies, no significant risks or safety events of concern were identified, and the study drug did not cause side-effects at any of the dose levels that will be used in clinical studies,” The Telegraph reported, citing Pfizer instructions.
The research is reportedly centred around a man-made anti-viral molecule – called PF 0732133 – which is a protease inhibitor, preventing the virus from reproducing in the nose, throat and lungs.
Protease inhibitors are a key element in the treatment of HIV patients, although the medication often does display long term side effects.
The ties to HIV will also be examined in the trials, with participants given doses of ritonavir, an antiviral drug used in the treatment of HIV that will help increase the amount of PF-07321332 in the participants’ blood.
The anti-viral pill was reportedly developed from scratch since the pandemic kicked off, according to Pfizer’s director of medicinal chemistry, David Owen.
He reportedly told a private event of the Division of Medicinal Chemistry last month that the first seven milligrams of the drug – the volume of a raindrop – were produced in July of last year while by late October, Pfizer had managed to create 100 grams of the drug, followed by a kilogram in November.