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NCT ID: NCT05088421 Completed - Clinical trials for Bacterial Infections

A First in Human Study of the Safety and Tolerability of Single and Multiple Doses of BWC0977 in Healthy Volunteers

Start date: November 5, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of single and multiple intravenous doses of BWC0977 when administered to healthy adult volunteers.

NCT ID: NCT05088369 Completed - Ulcerative Colitis Clinical Trials

Assessment of the Safety, Tolerability, and Pharmacokinetic of HM201

Start date: November 11, 2021
Phase: Phase 1
Study type: Interventional

This will be a single centre, Phase 1, Placebo-controlled, Randomized, Doubleblind, SAD & MAD Study to Assess the Safety, Tolerability and PK of HM201 in Healthy Subjects.

NCT ID: NCT05086692 Recruiting - Ovarian Cancer Clinical Trials

A Beta-only IL-2 ImmunoTherapY Study

ABILITY-1
Start date: August 27, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is a Phase 1/2, multi-center, open-label, dose-escalation and expansion study to evaluate safety and tolerability, PK, pharmacodynamic, and early signal of anti-tumor activity of MDNA11 alone or in combination with a checkpoint inhibitor in patients with advanced solid tumors.

NCT ID: NCT05086315 Recruiting - Clinical trials for Myelodysplastic Syndromes

First-in-human Study of SAR443579 Infusion in Male and Female Children and Adult Participants With Relapsed or Refractory Acute Myeloid Leukemia (R/R AML), B-cell Acute Lymphoblastic Leukemia (B-ALL), High Risk-myelodysplasia (HR-MDS), or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Start date: December 8, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open-label, multicenter, Phase 1/Phase 2, dose escalation and dose expansion study to evaluate the safety, pharmacokinetics, pharmacodynamics and anti-leukemic activity of SAR443579 in various hematological malignancies.

NCT ID: NCT05085366 Active, not recruiting - Clinical trials for Cytomegalovirus Infection

A Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Healthy Participants 16 to 40 Years of Age

Start date: October 26, 2021
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to evaluate the efficacy of mRNA 1647 vaccine in CMV-seronegative female participants and to evaluate the safety and reactogenicity of mRNA-1647 vaccine in all participants. The purpose of the Phase 3 extension sub study is to extend the observation period of the main study and to evaluate the longer-term immune persistence of mRNA-1647 vaccine administered to CMV-seronegative females who complete mRNA-1647-P301 main study and to assess for CMV seroconversion in CMV-seronegative participants who did not seroconvert during mRNA-1647-P301 main study. No interventional vaccine will be administered in the extension study.

NCT ID: NCT05084859 Active, not recruiting - Colorectal Cancer Clinical Trials

A Study Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of Orally Administered SM08502 Combined With Hormonal Therapy or Chemotherapy in Subjects With Advanced Solid Tumors

Start date: November 3, 2021
Phase: Phase 1
Study type: Interventional

This study is an open-label, multi-center, dose-escalation, dose expansion study in adult subjects with advanced solid tumors. The study will evaluate the safety, tolerability, PK, and preliminary anti-tumor efficacy of SM08502 administered orally (PO), once daily (QD), following a 5 days on 2 days off treatment schedule in combination with chemotherapy or hormonal therapy. Alternative dosing schedules may be explored in Part 1 if necessary. The recommended Part 2 dose and schedule for each combination will then be further evaluated in the Part 2 expansion. Dosing will occur in 21- or 28-day cycles (depending on the combination partner) and treatment with SM08502 will continue within each subject unless treatment is discontinued due to toxicity, disease progression, initiation of a new anti-neoplastic therapy, withdrawal of consent, the Sponsor terminates the study, or the subject no longer meets retreatment criteria.

NCT ID: NCT05083468 Completed - Healthy Volunteers Clinical Trials

The Safety, Tolerability, and Pharmacokinetics (PK) of SR750 in Healthy Volunteers

Start date: October 29, 2021
Phase: Phase 1
Study type: Interventional

This study is to evaluate the safety, tolerability, and PK of SR750 in healthy volunteers.

NCT ID: NCT05083364 Recruiting - IgA Nephropathy Clinical Trials

Study of ARO-C3 in Adult Healthy Volunteers and Patients With Complement Mediated Renal Disease

Start date: February 2, 2022
Phase: Phase 1
Study type: Interventional

The purpose of AROC3-1001 is to evaluate the safety, tolerability, pharmacokinetics and/or pharmacodynamics in adult healthy volunteers (HVs) and in adult patients with complement-mediated renal disease (C3 Glomerulopathy [C3G] and IgA Nephropathy [IgAN]). In Part 1 of the study, HVs will receive either one or two doses of ARO-C3 or placebo. In Part 2 of the study, adult patients with C3G/IgAN will receive 3 open-label doses of ARO-C3. Dose levels in Part 2 will be determined based on cumulative safety and pharmacodynamic data from Part 1.

NCT ID: NCT05083312 Completed - Clinical trials for Eosinophilic Esophagitis

Efficacy and Safety APT-1011 in Adolescent Subjects With Eosinophilic Esophagitis (EoE) - A Sub-Study of the FLUTE-2 Trial

FLUTEEN
Start date: September 30, 2021
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, placebo-controlled study of APT-1011, followed by an open-label extension (OLE) in adolescents (≥12 to <18 years) with EoE.

NCT ID: NCT05082545 Completed - Clinical trials for Advanced Malignant Tumors

Phase I Study of SHR-2002 + SHR-1316 in Patients With Advanced Malignant Tumors

Start date: November 23, 2021
Phase: Phase 1
Study type: Interventional

This is Phase 1 study FIH to check "Dose Escalation, Dose expansion and Indication expansion". This study is AUSTRALIA only study.