Title of Study. ☐Full title of study listed. ☐Short title contains the words “SHELL STUDY” before the title. ☐Brief description
Title of Study. A Phase 2A, Multi-center, Single-Blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of CRV431 Dosed Once Daily in XXXX induced F2 and F3 Subjects Primary: • To evaluate the safety and tolerability of once daily (QD) 75 mg and 225 mg doses of CRV431 in presumed nonalcoholic steatohepatitis (XXXX) fibrosis stage 2 (F2)/fibrosis stage 3 (F3) subjects compared to placebo control over 28 days of dosing; • To evaluate the pharmacokinetics (PK) of a QD dose of CRV431, its major metabolites and fraction unbound in presumed XXXX F2/F3 subjects over 28 days of dosing. Secondary: • To evaluate non-invasively the antifibrotic activity of a QD dose of CRV431, as measured by quantification of selected biomarkers of fibrosis, in presumed XXXX F2/F3 subjects over 28 days of dosing. Exploratory Objectives: • To generate exploratory data regarding the antifibrotic activity of a QD dose of CRV431 over 28 days of dosing by performing hepatic evaluations via laboratory assessments of biomarkers such: − Pharmacokinetic/pharmacodynamic (PK/PD) analyses to assess concentration effect relationship on all biomarkers; − Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) decrease from baseline. • Cohort A: Twelve (12) presumed XXXX F2/F3 subjects on CRV431 75 mg QD; • Cohort B: Six (6) presumed XXXX F2/F3 subjects on matching placebo for Cohort A. • Cohort C: Twelve (12) presumed XXXX F2/F3 subjects on CRV431 225 mg QD; • Cohort D: Six (6) presumed XXXX F2/F3 subjects on matching placebo for Cohort C.
Title of Study. A Randomized, Double-Blind, Dose-Ranging, Placebo- Controlled Study to Evaluate the Efficacy and Safety of Oral VB-201 in Patients with Moderate to Severe Plaque Psoriasis Sponsor: VBL Phase: Phase 2
Title of Study. A Phase II, Randomized, Active-controlled, Multi-center Study to Evaluate the Safety and Efficacy of Celgosivir in Combination with Peginterferon alfa-2b, with and without Ribavirin, for 12 Weeks in Patients with Chronic Hepatitis C Infection (Genotype 1) Who Failed to Respond to Pegylated α Interferon-based Therapy. Study Period (Planned): Start – August 2005 and End – April 2006 Phase of Development: II
Title of Study. A Phase 2 Randomized Single-Blind Study to Evaluate the Activity and Safety of Low Dose Oral Selinexor (KPT-330) in Patients with Severe COVID-19 Infection Protocol Number: XPORT-CoV-1001 Study Name: XPORT-CoV-1001
Title of Study. Type of research ☐ UG/ PG Academic Study ☐ Exempt Academic Study* ☐ Staff Academic Study ☐ Regulatory Clinical Trial *Studies that do not require CDSCO approval Reference Number Date received: Review Date: Outcome: ☐ Approval Applicant Informed ☐ Yes ☐ No ☐ Conditional Approval Date: ☐ Deferral ☐ Approval Declines Version No. Effective Date Page Please complete form and select YES/NO options as appropriate. An application will only be accepted for review by MNR-MC IEC if it is completed fully and the relevant enclosures are received. Complete the checklist on the next page before submitting the form. Where you have received permission to do this, please provide evidence of permission with this application. Please ensure that all copies of the same document are collated together in sets: • Application form • Study Protocol • Participant Consent Document • CRF • Questionnaire(s), if any • Investigator Brochure. Address to send application: The IEC Chair, MNR-MC Institutional Ethics Committee.
Title of Study. Your child or xxxx has been asked to participate in a research study investigating…[explanation of the purpose of the research].
Title of Study. (SK-FAN) An Open-Label Study Assessing Subject Satisfaction with A-101 (Hydrogen Peroxide) Topical Solution, 40% (w/w) Treatment for Seborrheic Keratoses of the Xxxx, Xxxx, and Décolletage. Studied period (months): 3 Estimated date first subject enrolled: March 5, 2018 Estimated date last subject completed: September 5, 2018 Phase of development: IV
Title of Study. A Phase 1/2, Open-label, Multicenter, Dose Escalation and Dose Expansion Study of NKTR‑214 and Nivolumab in Patients with Select Locally Advanced or Metastatic Solid Tumor Malignancies [***] [***] Phase of Development: Phase 1/2 [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] [***] NKTR-214 Please refer to Nektar Therapeutics’ Current Report on Form 8-K filed with the Securities and Exchange Commission on September 27, 2016.
Title of Study. A Phase 3, Double-Blind, Randomized, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken Daily at Bedtime in Patients with Military-Related PTSD (Protocol No. TNX-CY-P301) Studied period (years): 1.5 Estimated date first patient enrolled: February 2017 Estimated date last patient completed: January 2019 Studied period (months) for the post-study pharmacogenomic assessment: 3 Estimated date first patient enrolled: November 2019 Estimated date last patient completed: January 2020 Phase of development: 3
