safety and pharmacokinetic study of intranasal 2-dg in healthy volunteers

Conditions: Acute Nasopharyngitis

Summary: 2-dg-01 is a randomized, double-blind, placebo-controlled, single and multiple ascending dose phase 1 study assessing safety, tolerability and pharmacokinetics of 2-dg in normal healthy volunteers (nhv). the safety and pharmacokinetics of 2-dg are assessed after single or multiple intranasal administrations.

2-dg-01 is a randomized, placebo-controlled, double- blind single and multiple ascending dose phase 1 study in normal healthy male and female volunteers aged 18 years or older. the primary objective of this study is to assess the clinical safety and tolerability of intranasal 2-dg in nhvs. the secondary objective of this study is to assess the human pharmacokinetics of 2-dg. the study is divided in two sub-parts: part a, a single ascending dose (sad) study of 2-dg and part b, a multiple ascending dose (mad) study. part a consists of 3 cohorts: cohorts 1 and 2 with a randomization ratio for 2-dg to placebo of 4:1 and cohort 3 with a randomization ratio for 2-dg to placebo of 8:2. part b consists of 3 cohorts: cohort 4 with a a randomization ratio for 2-dg to placebo of 4:1 and cohorts 5 and 6 with a randomization ratio for 2-dg to placebo of 8:2. cohorts 1, 2 and 4 will also be controlled by randomized intranasal application of placebo into the opposite nostril to obtain an intra-individual estimate for local tolerability. other cohorts will receive either 2-dg or placebo into both nostrils. interim safety reviews are performed by a data monitoring committee.

Eligibility criteria:
inclusion criteria: * healthy male or female volunteers, age ≥ 18 years old at screening * females must be post-menopausal (\> 1 year since last menstruation) * able to comprehend and to give informed consent * able to cooperate with the investigator, to comply with the requirements of the study, and to complete the full sequence of protocol-related procedures * undergone full immunisation against sars-cov2 or status post infection with sars-cov2 (both as defined by the austrian ministry of health) exclusion criteria: * frequent epistaxis (equal to or greater than 1/month) * hypo- or anosmia * symptoms of rhinitis, allergy or common cold disease at screening and at study initiation * medical history of diabetes mellitus of any type * clinically relevant abnormal findings at screening * preceding nasal surgery or sinus surgery * medical history of allergic rhinitis or chronic condition of the upper or lower respiratory tract with active symptoms within 30 days prior to screening * sars-cov-2 infection positive by pcr test at screening * vulnerable subjects as defined by gcp * subjects in a dependency relationship towards the investigators, e.g. as employees * substance abuse, mental illness, or any reason that makes it unlikely in the judgment of the investigator for the subject to be able to comply fully with study procedures * use of medication (including prophylactic treatments) during 2 weeks before the start of the study, which in the judgment of the investigator may adversely affect the subject's welfare or the integrity of the study's results * concurrent treatment with other experimental product or participation in another clinical trial with any investigational product within 30 days or 5 elimination half-lives (whichever is longer) prior to treatment start * scheduled vaccination appointments during the study period

Keywords: virus disease respiratory infection common cold virus rhinovirus