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Seelos Therapeutics Announces Dosing of Phase I PK/PD Study of Intranasal Racemic Ketamine (SLS-002)Preliminary Data Expected in the First Quarter of 2020
Published:

Cellectis announced that the first patient enrolled in the dose escalation Phase 1 clinical study for its UCART22 product candidate has been dosed at The University of Texas MD Anderson Cancer Center.

QBiotics Announces First Patient Dosed in its Phase I/II Clinical Trial of Tigilanol Tiglate for Head and Neck Cancer
Published:

Advaxis, Inc. (Nasdaq: ADXS), today announced it has submitted an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for the initiation of a Phase 1 clinical study of ADXS-504, the Company’s ADXS-HOT drug candidate for prostate cancer.

1st Patient Dosed with Cellectis’ Allogeneic UCART22 in Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia
Published:

Acceptance of the IND application will allow the company to begin Phase I clinical trials for SKL24741 in 2020

A Multi-centre, Phase I, Open-label, Single-dose Study to Investigate Pharmacokinetics (PK) of Ticagrelor in Infants and Toddlers, Aged 0 to less than 24 Months, with Sickle Cell Disease
Published:

EudraCT Number: 2017-003641-14
Sponsor Protocol Number: D5136C00010
Sponsor Name: AstraZeneca AB
Start Date: 2018-01-29
Medical condition: Sickle Cell Disease
Disease:
Version: 20.0
SOC Term: 100000004850
Classification Code: 10040644
Term: Sickle cell disease
Level: LLT

Population Age: Newborns, Infants and toddlers, Under 18
Gender: Male, Female
Trial Protocol: BE (Ongoing), ES (Completed), GB (Completed), IT (Completed)

Study of ANX007 in Participants With Primary Open-angle Glaucoma
Published: 5 Dec 2019 | 17:00 UTC

Condition:   Open Angle Glaucoma
Interventions:   Biological: 2.5mg ANX007;   Biological: 5.0mg ANX007;   Other: Sham Procedure
Sponsor:   Annexon, Inc.
Completed

A Study in Healthy Male Subjects to Understand How Savolitinib When Taken With Midazolam Behaves Inside the Body
Published: 5 Dec 2019 | 17:00 UTC

Condition:   Solid Tumors
Interventions:   Drug: Savolitinib;   Drug: Midazolam
Sponsors:   AstraZeneca;   Parexel
Not yet recruiting

MS-553 in Diabetic Retinopathy Patients With Central Involved Macular Edema
Published: 5 Dec 2019 | 17:00 UTC

Conditions:   Diabetic Macular Edema;   Macular Edema;   Type 2 Diabetes With Diabetic Macular Edema;   Type 1 Diabetes With Diabetic Macular Edema;   Diabetic Retinopathy
Intervention:   Drug: MS-553
Sponsors:   Shenzhen MingSight Relin Pharmaceuticals Co., Ltd.;   Fountain Medical Development Co., Ltd.
Not yet recruiting

Duration of Severe Neutropenia After the Same-Day, Varying Dosing Time Schedules of Eflapegrastim Administration in Patients With Breast-Cancer Receiving Docetaxel and Cyclophosphamide
Published: 5 Dec 2019 | 17:00 UTC

Conditions:   Neutropenia;   Breast Cancer
Interventions:   Drug: Eflapegrastim;   Drug: Docetaxel;   Drug: Cyclophosphamide
Sponsor:   Spectrum Pharmaceuticals, Inc
Not yet recruiting

LITT and Pembrolizumab in Recurrent Brain Metastasis
Published: 5 Dec 2019 | 17:00 UTC

Conditions:   Melanoma;   Non-small Cell Lung Carcinoma (NSCLC);   Renal Cell Carcinoma (RCC);   Brain Metastases
Intervention:   Combination Product: LITT + Pembrolizumab
Sponsors:   University of Florida;   Monteris Medical Corporation
Not yet recruiting

5-Azacitidine and Decitabine Epigenetic Therapy for Myeloid Malignancies
Published: 5 Dec 2019 | 17:00 UTC

Conditions:   Myelodysplastic Syndromes;   MDS/MPN Crossover Syndromes
Interventions:   Drug: 5-azacytidine;   Drug: Decitabine
Sponsor:   Case Comprehensive Cancer Center
Not yet recruiting

Extension Study for Patients Who Had Not Met Criteria for Discontinuation in Previous Sponsored Belinostat Trials
Published: 4 Dec 2019 | 17:00 UTC

Conditions:   Solid Tumor;   Hematological Malignancies
Interventions:   Drug: Belinostat;   Drug: Atazanavir
Sponsors:   Acrotech Biopharma LLC;   Axis Clinicals Limited
Recruiting

Effect of Lidocaine Phonophoresis Versus Pulsed Ultrasound on Myofascial Pain Syndrome in Athletic Children
Published: 4 Dec 2019 | 17:00 UTC

Condition:   Treatment Side Effects
Interventions:   Drug: Lidocaine;   Device: pulsed ultrasound;   Other: especially designed physical therapy program
Sponsor:   Cairo University
Completed

Safety and Effectiveness of the PXL-Platinum 330 System for CXL Using Riboflavin Solution
Published: 26 Nov 2019 | 17:00 UTC

Conditions:   Keratoconus;   Pellucid Marginal Corneal Degeneration;   Corneal Degeneration;   Corneal Ectasia
Intervention:   Combination Product: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution
Sponsor:   Cornea Associates of Texas
Suspended

IVF Outcome Following Progestogen Ovarian Stimulation
Published: 25 Nov 2019 | 17:00 UTC

Conditions:   IVF;   Oocyte Maturation Defect 1;   Clinical Pregnancy Rate;   Ovarian Hyperstimulation
Intervention:   Drug: Dydrogesterone Pill
Sponsor:   National University of Malaysia
Completed

Gemcitabine in Newly-Diagnosed Diffuse Midline Glioma
Published: 9 Aug 2019 | 16:00 UTC

Conditions:   Glial Tumor of Brain;   Diffuse Intrinsic Pontine Glioma;   Glioma
Interventions:   Drug: Gemcitabine;   Procedure: Tumor biopsy and blood draw
Sponsors:   University of Michigan Rogel Cancer Center;   University of Colorado, Denver
Withdrawn

Hyperbaric Oxygen Therapy and Allogeneic Peripheral Blood Stem Cell (PBSC) Transplant
Published: 27 May 2019 | 16:00 UTC

Conditions:   Acute Myeloid Leukemia;   Myelodysplastic Syndromes;   Myelofibrosis
Intervention:   Drug: Hyperbaric oxygen
Sponsor:   Omar Aljitawi
Withdrawn

A Study in Healthy Men and Women to Find Out How Well Different Doses of BI 1291583 Are Tolerated
Published: 11 Mar 2019 | 16:00 UTC

Condition:   Healthy
Interventions:   Drug: BI 1291583;   Drug: Placebo
Sponsor:   Boehringer Ingelheim
Suspended

Cefiderocol Concentrations in the Lungs of Hospitalized Patients With Bacterial Pneumonia
Published: 5 Mar 2019 | 17:00 UTC

Condition:   Bacterial Pneumonia
Interventions:   Drug: Cefiderocol;   Drug: Standard of Care Antibiotic
Sponsor:   Shionogi
Terminated

Adult Healthy Volunteers Study to Evaluate ALPN-101 Safety
Published: 21 Nov 2018 | 17:00 UTC

Condition:   Healthy Volunteers
Interventions:   Drug: ALPN-101;   Drug: Placebo
Sponsors:   Alpine Immune Sciences, Inc.;   Clinical Network Services (CNS) Pty Ltd
Completed

A Study to Evaluate the Long-term Safety and Tolerability of Lu AF20513 and the Antibody Response in Patients With Alzheimer's Disease (AD)
Published: 12 Sep 2018 | 16:00 UTC

Condition:   Alzheimer's Disease
Intervention:   Drug: Lu AF20513
Sponsor:   H. Lundbeck A/S
Terminated

Safety, Tolerability, Pharmacokinetics & Pharmacodynamics Study of Ropeginterferon Alfa-2b in Healthy Japanese and Caucasian Subjects
Published: 5 Jun 2018 | 16:00 UTC

Condition:   Healthy Volunteers
Intervention:   Drug: ropeginterferon alfa-2b
Sponsors:   PharmaEssentia Japan K.K.;   PharmaEssentia
Completed

A Two Part Study to Assess Safety, PK, PD, and Food Effect of Oral HTL0016878
Published: 9 Aug 2017 | 16:00 UTC

Condition:   Healthy
Interventions:   Drug: HTL0016878;   Drug: Placebo - Concentrate
Sponsors:   Heptares Therapeutics Limited;   Allergan
Completed



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