On Aug. 3, 2020, Atossa Therapeutics announced that it had received approval from the ethics committee to open a Phase 1 clinical study using Atossa’s proprietary drug candidate AT-301, to be administered by nasal spray. All necessary approvals had now been obtained and enrollment is expected to begin in the next 30 days.

The study is a double-blinded, randomized, and placebo-controlled safety study of AT-301 nasal spray in 32 healthy adult subjects divided into two study groups. Part A consists of two single-dose cohorts receiving either active therapy, AT-301B, or the placebo comparator AT-301A at two different doses. Part B is a multiple dose arm with cohorts receiving either AT-301A or AT-301B for 14 days at two different doses.

The primary objective of the study is to evaluate the safety and tolerability of single and multiple doses of AT-301 administered via nasal instillation to healthy volunteers. Secondary objectives are to assess the incidence and severity of local irritation and bronchospasm following administration of AT-301 via nasal instillation. The study is being conducted in Australia.