A randomized pharmacokinetic/pharmacodynamic study comparing the bioequivalence of potential biosimilar candidate P044 with reference medicine in healthy volunteers.

BACKGROUND: P044 is a proposed biosimilar candidate of Teriparatide for reference medicine, Forsteo®. This study was designed to evaluate the Pharmacokinetic/Pharmacodynamic (PK/PD) bioequivalence between P044 and Forsteo®. METHODS: In this randomized, open-label, single-dose, crossover study, 66 healthy female subjects were randomized to receive P044 and Forsteo®. The primary PK endpoints of the study were the area under the concentration versus time from zero to infinity (AUC0-inf) and maximum plasma concentration (Cmax). Secondary endpoints included area under the concentration versus time from zero to the last quantifiable concentration (AUC0-last) and Cmax for PD parameter, additional PK parameters and safety. RESULTS: Sixty-six subjects were enrolled in the study and baseline demographics were similar between the two treatments. The two treatments presented similar PK/PD parameters and the 90% confidence interval for primary and secondary endpoints were within the bioequivalence acceptance range (80.00-125.00%) for all parameters. None of the subjects experienced serious adverse event, and all of the reported adverse events were mild and similar between two treatments. CONCLUSIONS: This study demonstrated the PK/PD similarity of P044 to reference medicine, Forsteo® and safety profiles were comparable between treatments. TRIAL REGISTRATION: EudraCT Number: 2019-004477-82.

Interferon beta-1a as a Candidate for COVID-19 Treatment;An Open Label Single-Arm Clinical Trial

Introduction: Since December 2019, an outbreak of Covid-19 has caused growing concern in multiple countries. Researchers around the world are working to find a treatment or a vaccine for Covid-19 and different treatment approaches have been tested in this regard. Objective: This study was designed and conducted to assess the possible efficacy of Interferon beta-1a as a safe and efficient candidate for Covid-19 treatment. Methods: This is an investigator-initiated, open-label, single-arm clinical trial. Twenty patients with suspected Covid-19, who were admitted to Sina hospital in Tehran, Iran, with moderate to severe symptoms, from 6 to 10 March, 2020, were enrolled. Patients were treated with antiviral and hydroxychloroquine combination therapy, along with subcutaneous Interferon beta-1a for 5 consecutive days. Baseline characteristics and findings during the course of admission and 5 days after discharge were recorded for all the patients. Results: In total, 20 patients with suspected Covid-19 were included in this study, 12 (60%) of which were male. The median (Interquartile (IQ) range) of patients' age was 55.5 (43-63.5). The most common symptom of the patients at onset of disease was fever. The median (IQ range) of duration of hospital stay was 5.0 (3-6) days. Only 2 cases were admitted to ICU. At the time of follow-up, 15 (94%) patients reported that they generally felt good and had oral tolerance, 1 patient had suffered from dyspnea, 5 patients had suffered from cough, none of them had experienced fever and no case of re-admission or death was reported after discharge. Conclusions: Results of the current study are in favor of using Interferon beta-la in addition to recommended antiviral treatment in Covid-19 patients.