Clinical Trials - Phase I

Found 19,649 articles

• Minghui Pharmaceutical Inc. Announces First-in-Human Dose of MHB018A, a Subcutaneous Single-Domain IGF-1R Antibody in Phase 1a Healthy Volunteer Study

  5/23/2023

  Minghui Pharmaceutical, Inc., today announced that the phase 1a trial of MHB018A has commenced with the dosing of its first subject.

• Verge Genomics to Incorporate Emerald Digital Health Technology into its ALS Phase 1b Proof-of-Concept Clinical Trial

  5/23/2023

  Verge Genomics announced that Emerald Innovations’ wireless digital health technology will be used to capture critical patient data in its planned Phase 1b proof-of-concept study of the PIKfyve inhibitor VRG50635, a novel therapeutic in clinical development for amyotrophic lateral sclerosis (ALS).

• Spago Nanomedical has Submitted Application to Start Tumorad(R) Clinical Phase I/IIa Study

  5/23/2023

  Spago Nanomedical AB announced that the final step in the preparations for the clinical phase I/IIa trial in cancer patients, Tumorad-01, with its leading candidate drug 177Lu-SN201 has begun in Australia.

• AnaMar Announces Positive Phase I Data for its Phase II Ready Compound AM1476 for Treating Fibrosis

  5/23/2023

  AnaMar, a clinical-stage biotech company developing a first-in-class, peripheral 5-HT2B receptor antagonist, AM1476, as a pan anti-fibrotic medicine, announces positive results from its Phase I study, and the completion of Phase II enabling pre-clinical studies for its initial orphan indication in systemic sclerosis characterized by lung and skin fibrosis.

• Zentalis to Host Investor Call to Provide Clinical Update with Safety, Pharmacology, and Efficacy Results for Azenosertib Monotherapy and Development Plans for Monotherapy and Chemotherapy Combinations

  5/23/2023

  Zentalis ® Pharmaceuticals, Inc. today announced that the Company will host an investor update call to share the safety and efficacy results from its ongoing monotherapy dose optimization Phase 1 study of azenosertib, its potentially first-in-class WEE1 inhibitor product candidate.

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  ReCode–a New Contestant in the mRNA Race  

  5/22/2023

  ReCode plans to use its SORT LNP genetic medicines delivery technology to treat CF and PCD patients who don’t respond to current treatments.

• Clearmind Medicine Announces First US Site for its Phase I/IIa Clinical Trial Evaluating CMND-100 in Patients with Alcohol Use Disorder

  5/22/2023

  Clearmind Medicine Inc. today announced the selection of its first U.S. site for the company’s Phase I/IIa clinical trial of its proprietary MEAI-based CMND-100 compound for the treatment of alcohol use disorder ("AUD").

• HiberCell Doses First Patient in Phase 1b Study Exploring Novel Combination of Odetiglucan and CD40 Agonistic Monoclonal Antibody (CDX-1140) in Patients With Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) in the Maintenance Setting

  5/22/2023

  HiberCell today announced dosing of the first patient in a Phase 1b clinical trial investigating the effects of odetiglucan, a first-in-class immunomodulatory agent, in combination with the CD40 agonistic monoclonal antibody, CDX-1140, in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) in the maintenance setting.

• Panbela Announces Clinical Trial with Moffitt Cancer Center for Phase I/II Program in STK11 Mutant Non-Small Cell Lung Cancer

  5/22/2023

  Panbela Therapeutics, Inc. today announced it has entered into a clinical trial agreement with Moffitt Cancer Center for a Phase I/II program in STK11 mutant non-small cell lung cancer (NSCLC).

• Icosavax Announces Positive Topline Interim Phase 1 Results for Bivalent VLP Vaccine Candidate IVX-A12 Against RSV and hMPV in Older Adults

  5/22/2023

  Icosavax, Inc. (Nasdaq: ICVX) today announced positive topline interim results from its Phase 1 clinical trial of IVX-A12 against respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) in older adults.

• Upstream Bio Presents New Phase 1 Clinical Data on UPB-101 at the American Thoracic Society (ATS) International Conference

  5/22/2023

  Upstream Bio, a clinical-stage biotech company advancing new therapies to treat inflammation, today presented new clinical data from its Phase 1 clinical study of UPB-101, a thymic stromal lymphopoietin receptor (TSLPR) inhibitor, at the American Thoracic Society (ATS) International Conference in Washington, DC.

• Acepodia Announces First Patient Dosed in Phase 1 Clinical Trial of ACE1831, an Anti-CD20 Armed Allogeneic Gamma Delta T-cell Therapy in Development to Treat Patients with Non-Hodgkin's Lymphoma

  5/22/2023

  Acepodia, a clinical stage biotechnology company developing first-in-class cell therapies with its unique Antibody-Cell Conjugation (ACC) platform to address gaps in cancer care, today announced that the first patient has been dosed with ACE1831 in a Phase 1, first-in-human clinical trial for patients with non-Hodgkin's lymphoma.

• BridgeBio Pharma Presents Updated Encouraging Clinical and Biomarker Data from its BBP-812 Canavan Disease Gene Therapy Program at the 2023 American Society of Gene and Cell Therapy (ASGCT) Annual Meeting

  5/22/2023

  BridgeBio Pharma, Inc. presented promising positive data from six participants dosed in CANaspire, its Phase 1/2 clinical trial of BBP-812, an investigational intravenous (IV) adeno-associated virus serotype 9 (AAV9) gene therapy for the treatment of Canavan disease.

• IDEAYA Announces IND Clearance Enabling Phase 1/2 Clinical Trial for Combination of IDE397 and AMG 193 in MTAP-Deletion Solid Tumors

  5/22/2023

  IDEAYA Biosciences, Inc. announced that the U.S. Food and Drug Administration has completed its review of the Amgen-sponsored Investigational New Drug application and concluded that the proposed clinical study may proceed to evaluate IDE397 in combination with AMG 193 in solid tumors having MTAP deletion.

• AiViva Biopharma Initiates Phase 1 Clinical Trial of AIV007 for Age-Related Macular Degeneration and Diabetic Macular Edema

  5/22/2023

  AiViva Biopharma Inc., a clinical-stage biotechnology company, announced that it has begun a Phase 1 trial and completed dosing the first cohort of patients diagnosed with wet age-related macular degeneration, and/or diabetic macular edema.

• Keros Therapeutics Presents Preclinical and Clinical Data from its KER-012 Program at the American Thoracic Society International Conference

  5/22/2023

  Keros Therapeutics, Inc. (“Keros”) (Nasdaq: KROS) today announced that it presented additional biomarker data from its completed Phase 1 clinical trial of KER-012 in healthy post-menopausal women at the American Thoracic Society (“ATS”) 2023 International Conference.

• Nexcella Announces Positive NXC-201 Clinical Results at ASGCT: 100% Overall Response Rate in DARZALEX-Relapsed/Refractory AL Amyloidosis with Zero ICANs in Ongoing NEXICART-1 Phase 1b/2a Clinical Trial

  5/21/2023

  Nexcella, Inc. announced updated AL Amyloidosis clinical data from its ongoing Phase 1b/2a NEXICART-1 study of its novel, autologous, BCMA-targeted chimeric antigen receptor T cell therapy NXC-201 for the treatment of patients with relapsed or refractory multiple myeloma and light chain amyloidosis.

• Immix Biopharma Announces Positive NXC-201 Clinical Results at ASGCT: 100% Overall Response Rate in DARZALEX-Relapsed/Refractory AL Amyloidosis with Zero ICANs in Ongoing NEXICART-1 Phase 1b/2a Clinical Trial

  5/21/2023

  Immix Biopharma, Inc., announced updated AL Amyloidosis clinical data from its ongoing Phase 1b/2a NEXICART-1 study of its novel, autologous, BCMA-targeted chimeric antigen receptor T cell therapy NXC-201 for the treatment of patients with relapsed or refractory multiple myeloma and light chain amyloidosis.

• Neurimmune: Promising Phase 1 Results for Antibody NI006 in ATTR Cardiomyopathy Published in the New England Journal of Medicine

  5/20/2023

  Neurimmune announced that primary results of its Phase 1 proof-of-concept study of NI006, a recombinant human antibody to deplete amyloid deposits in ATTR cardiomyopathy, have been presented in Prague at Heart Failure 2023, a scientific congress of the European Society of Cardiology, and published in The New England Journal of Medicine.

• Salubris Biotherapeutics Presents Positive Updates from Phase 1b Clinical Trial of JK07 in Late-Breaking Session at the European Society of Cardiology Heart Failure 2023 Congress

  5/20/2023

  Salubris Biotherapeutics, Inc., a clinical-stage biotechnology company dedicated to discovering and developing novel complex biologic therapeutics, announced positive updated results from the ongoing Phase 1b study of JK07 in heart failure with reduced ejection fraction.