A Phase 2a, randomized, blinded, placebo-controlled, multi-center trial to evaluate the safety, tolerability and immunological profile of INO-4700 administered by intradermal (ID) injection followed by electroporation (EP) using the CELLECTRATM 2000 device in healthy adult volunteers

Inovio Pharmaceuticals Inc0 个研究点目标入组 542 人开始时间: 2020年12月3日最近更新: 2023年5月29日

试验速览

暂无简介。

•Judged to be healthy by the Investigator on the basis of medical history, physical examination and vital signs performed at Screening;
•Able and willing to comply with all study procedures;
•Screening laboratory results within normal limits;
•Negative tests for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody and Human Immunodeficiency Virus (HIV) antibody;
•Screening electrocardiogram (ECG) deemed by the Investigator as having no clinically significant findings (e.g. Wolff-Parkinson-White syndrome);
•Be post-menopausal or be surgically sterile or have a partner who is sterile or use medically effective contraception with a failure rate of < 1% per year when used consistently and correctly from screening until 1 month following last dose.

•Pregnant or breastfeeding, or intending to become pregnant or father children within the projected duration of the trial starting with the screening visit until 1 month following last dose;
•History of respiratory diseases such as asthma, chronic obstructive pulmonary disease (COPD) or chronic bronchitis;
•Currently participating in or has participated in a study with an investigational product within 30 days preceding Day 0;
•Previous receipt of an investigational vaccine product for the prevention of MERS or severe acute respiratory syndrome (SARS);
•Prior exposure to MERS-CoV or camels;
•Participants who participate in MERS-201 Part 1 cannot participate in MERS-201 Part 2;
•Fewer than two acceptable sites available for ID injection and EP considering the deltoid and anterolateral quadriceps muscles;
•Prisoner or participants who are compulsorily detained (involuntary incarceration);
•Current or anticipated concomitant immunosuppressive therapy (excluding inhaled, topical skin and/or eye drop-containing corticosteroids) prior to dosing. Systemic corticosteroids must be discontinued at least 3 months prior to first dose;
•Reported active drug or alcohol or substance abuse or dependence.

发起方

Inovio Pharmaceuticals Inc