Clinical Trials (Phase I)
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ACTG Announces Launch of Clinical Trial Evaluating Combination of Three Novel Immune-based Therapies for HIV CureStudy will enroll participants who initiated treatment shortly after acquiring HIV
4/19/2024
ACTG today announced the opening of A5374, a phase 1/2a study evaluating the safety, tolerability, and antiviral effect of a novel combination regimen that includes therapeutic T-cell vaccines, two broadly neutralizing antibodies (bNAbs), and an immune-system boosting treatment among people living with HIV who started antiretroviral treatment (ART) during acute (early) HIV infection.
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Ocugen Announces Dosing Completion of Subjects with Geographic Atrophy in Cohort 2 of Phase 1/2 ArMaDa Clinical Trial of OCU410—A Modifier Gene Therapy
4/19/2024
Ocugen, Inc. today announced that dosing is complete in the second cohort of its Phase 1/2 ArMaDa clinical trial for OCU410 (AAV- hRORA ).
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Barinthus Bio Announces Topline Data from Phase 1b/2 APOLLO Trial of VTP-200 in Persistent High-Risk Human Papillomavirus (HPV) Infections
4/18/2024
Barinthus Biotherapeutics plc (NASDAQ: BRNS) today announced topline final data from the APOLLO trial (also known as HPV001), a completed randomized, placebo-controlled Phase 1b/2 dose-ranging trial of VTP-200 in women with low-grade cervical lesions associated with persistent hrHPV infection.
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Immutep Appoints Leading Research Institute to Conduct First-in-Human Phase I Study of IMP761
4/18/2024
Immutep Limited today announces it has entered into an agreement with the Centre for Human Drug Research (CHDR), a world-class institute in Leiden, the Netherlands specializing in cutting-edge early-stage clinical drug research, to perform a first-in-human clinical study of IMP761.
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IMUNON’s IND Application Cleared to Begin Human Testing of IMNN-101
4/18/2024
IMUNON, Inc. (NASDAQ: IMNN), a clinical-stage drug-development company focused on developing non-viral DNA-mediated immunotherapy and next-generation vaccines, announces receipt of clearance from the U.S. Food and Drug Administration (FDA) to begin a Phase 1 clinical trial with a seasonal COVID-19 booster vaccine.
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D2M Biotherapeutics Announces First Patient Dosed in A Phase 1 Study Evaluating
4/18/2024
D2M Biotherapeutics, Inc. (D2M) today announced that the first patient had been dosed in a phase 1, open-label, dose escalation and expansion study of DM919, a novel monoclonal antibody targeting MICA/B to restore and promote anti-tumor response by T and natural killer (NK) cells for the treatment of advanced solid tumors.
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Oncternal Announces First Patient Dosed in Fourth Cohort of Phase 1/2 Study of ONCT-534 for the Treatment of R/R Metastatic Castration-Resistant Prostate Cancer
4/18/2024
Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, today announced that the first patient has been dosed in the fourth cohort of its Phase 1/2 study of ONCT-534 for the treatment of patients with advanced prostate cancer who are relapsed or refractory to approved androgen receptor pathway inhibitors (ARPI).
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Benitec Biopharma Reports Positive Interim Clinical Trial Data for First OPMD Subject Treated with BB-301 in Phase 1b/2a Study
4/18/2024
Benitec Biopharma Inc. today announces positive interim clinical data from the 90-day timepoint following the administration of BB-301 to the study’s first subject (Subject 1) treated in the BB-301 Phase 1b/2a single-arm, open-label, sequential, dose-escalation cohort study (NCT06185673) in Oculopharyngeal Muscular Dystrophy (OPMD).
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Bio-Path Holdings Announces Successful Completion of Higher Dose Second Cohort in Phase 1/1b Clinical Trial of BP1002 in Refractory/Relapsed Acute Myeloid Leukemia (AML) Patients
4/18/2024
Bio-Path Holdings, Inc. today announced completion of the second dose cohort of the dose escalation portion of its Phase 1/1b clinical trial of BP1002 evaluating the ability of BP1002 to treat refractory/relapsed acute myeloid leukemia.
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Artiva Biotherapeutics Announces First Patient Dosed in Phase 1 Trial of AlloNK® Cell Therapy Candidate in Lupus Nephritis
4/17/2024
Artiva Biotherapeutics, Inc., a clinical-stage company whose mission is to deliver highly effective, off-the-shelf, allogeneic natural killer (NK) cell-based therapies, announced today that the first patient has been dosed in its Phase 1 trial of AlloNK®.
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Ventus Therapeutics Announces Results from Phase 1 Clinical Trial of VENT-02, a Novel, Orally Administered, Brain-Penetrant NLRP3 Inhibitor
4/17/2024
Ventus Therapeutics today announced results from its Phase 1 clinical trial of VENT-02, a novel, oral, brain-penetrant NLRP3 inhibitor.
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Aspen Neuroscience Announces First Patient Dosed in First-in-Human Phase 1/2a Clinical Trial of Autologous Neuronal Cell Replacement Therapy for Parkinson's Disease
4/17/2024
Aspen Neuroscience, Inc. announced that the first patient has been dosed in the ASPIRO trial, a Phase 1/2a open label clinical trial to assess safety and tolerability of ANPD001, an autologous, dopaminergic neuron cell replacement therapy for participants with moderate to severe Parkinson's disease (PD).
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NeuroBo Pharmaceuticals Doses First Patient in Its Phase 1 Clinical Trial Evaluating DA-1726 for the Treatment of Obesity
4/17/2024
NeuroBo Pharmaceuticals, Inc. today announced dosing of the first patient in the single ascending dose (SAD) Part 1 of its two-part Phase 1 clinical trial of DA-1726, a novel, dual oxyntomodulin (OXM) analog agonist that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR), for the treatment of obesity.
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atai Life Sciences Announces the Publication of Beckley Psytech’s Phase 1 Study of BPL-003 in the Journal of Psychopharmacology
4/17/2024
atai Life Sciences (NASDAQ: ATAI) (“atai” or “Company”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, today announced the publication of the Phase 1 results of BPL-003, Beckley Psytech’s novel, synthetic, intranasal benzoate salt formulation of 5-MeO-DMT, in The Journal of Psychopharmacology.
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In a Phase I/II study, Ultragenyx’s antisense oligonucleotide GTX-102 led to significant cognitive, behavioral, sleep and gross motor improvements in patients with the rare genetic disorder Angelman syndrome.
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Volastra Therapeutics Announces First Patient Dosed in Phase Ib Clinical Trial of Sovilnesib
4/16/2024
Volastra Therapeutics today announced it has dosed the first patient in its Phase Ib clinical trial evaluating sovilnesib in patients with platinum-resistant or refractory high-grade serous ovarian cancer (HGSOC).
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Compass Therapeutics Announces First Patient Dosed in the Phase 1 Study of CTX-8371 in Patients with Solid Tumors
4/16/2024
Compass Therapeutics, Inc. today announced that the first patient has been dosed in its Phase 1 dose-escalation clinical trial of CTX-8371, a PD-1 x PD-L1 bispecific antibody, in patients with solid tumors.
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Enlivex Announces Authorization from the Danish Regulatory Agency for the Company’s Randomized, Controlled Phase I/II Trial Evaluating Allocetra in Patients with Knee Osteoarthritis
4/16/2024
Enlivex Therapeutics Ltd. today announced that the Danish Medicines Agency (DKMA) authorized the expansion into Denmark of the Company’s multi-country, randomized, controlled Phase I/II trial evaluating Allocetra TM in up to 160 patients with moderate to severe knee osteoarthritis.
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Following cases of convulsions in rabbits in a preclinical study, the FDA has placed a clinical hold on Neumora Therapeutics’ Phase I schizophrenia drug candidate NMRA-266.
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ORIC Pharmaceuticals Announces First Patients Dosed Across Three Expansion Cohorts in Phase 1b Trial of ORIC-114 in Patients with Mutated NSCLC
4/15/2024
ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today announced the completion of the dose escalation portion of the Phase 1b trial of ORIC-114 in patients with advanced solid tumors with EGFR and HER2 exon 20 alterations or HER2 amplifications.