Clinical trials: Phase I
Healthy
A Study of PRA023 in Healthy Volunteers
This is randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PRA023 in healthy volunteers.
- Trial name
- NCT04676178
- Testing
- PRA023
- Where
- United States
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Advanced Solid Tumor Cancers, Medulloblastoma
Dose Finding and Safety of Oral LDE225 in Patients With Advanced Solid Tumors
This first-in-human dose-escalation study is to characterize the safety, tolerability, pharmacokinetics and pharmacodynamics of LDE225 given orally on a daily dosing schedule in patients with advanced solid tumors.
- Conditions
- Advanced Solid Tumor Cancers, Medulloblastoma, Basal Cell Carcinoma
- Trial name
- NCT00880308
- Testing
- LDE225
- Where
- 5 sites in United States, Spain and 2 more
- Volunteers
- 103 people
- Sponsor
- Novartis Pharmaceuticals
Healthy
A Study to Assess the Safety, Tolerability and Pharmacokinetics of PAC-14028 Cream in Healthy Male Subjects
The purpose of this study is to investigate the safety/tolerability and pharmacokinetics of PAC-14028 cream after transdermal administration in healthy male volunteers.
- Trial name
- NCT02309008
- Testing
- PAC-14028, Vehicle
- Where
- South Korea
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Amorepacific Corporation
Healthy
A Study of LY4268989 (MORF-057) in Healthy Participants
The purpose of this study is to measure the body's absorption and processing of the study drug, the study drug's effect on the body, safety, and tolerability with LY4268989 (MORF-57) in healthy participants, including Japanese…
- Trial name
- NCT06964776
- Testing
- LY4268989, Midazolam
- Where
- United States
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
ADME
Mass Balance Study of [14C]Xeruborbactam (QPX7728) in Healthy Adult Male Participants
This is a single-dose, phase 1 open-label study to determine the mass balance recovery and metabolic profiling and identification for intravenous (IV) administered [14C]xeruborbactam.
- Trial name
- NCT07083817
- Testing
- [14C]Xeruborbactam
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Qpex Biopharma, Inc.
Advanced Solid Tumors, Genital Neoplasm, Female
A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors
This is an open label, multicenter, phase 1/2 study to assess the safety/tolerability and preliminary clinical activity of STAR0602 as a single agent and in combination with chemotherapy administered intravenously in participants…
- Conditions
- Advanced Solid Tumors, Genital Neoplasm, Female, Urogenital Neoplasms, Lung Neoplasm
- Trial name
- START-001 (NCT05592626)
- Testing
- STAR0602, Irinotecan (Camptosar), Docetaxel (Taxotere)
- Where
- 19 sites in United States, Canada and 2 more
- Volunteers
- 366 people
- Sponsor
- Marengo Therapeutics, Inc.
Atopic Dermatitis
A Study of Orally Administered IPG7236 in Healthy Adult Participants
The study is a phase 1, randomized, double-blind, placebo-controlled, single and multiple dose escalation study to evaluate the safety, tolerability, pharmacokinetic and food effect of orally administered IPG7236 in healthy adult…
- Trial name
- NCT05288543
- Testing
- IPG7236- Single ascending dose, IPG7236- Multiple ascending dose
- Where
- Australia
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Nanjing Immunophage Biotech Co., Ltd
Mantle Cell Lymphoma, COVID-19
A Study in Healthy Subjects to Assess Bioavailability (Proportion of a Drug Which Enters the Circulation to Have an Active Effect) of Acalabrutinib Tablet and Protonpump Inhibitor Effect (Members of a Class of Medications That Inhibits in Gastric Acid Production) for Rabeprazole
This Phase 1 study is being conducted to support the clinical development of acalabrutinib in hospitalized patients who are unable to swallow acalabrutinib tablet or capsule due to respiratory failure, eg, they may require…
- Trial name
- NCT04564040
- Testing
- Acalabrutinib Treatment A, Acalabrutinib Treatment B, Acalabrutinib Treatment C
- Where
- Germany
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Advanced Solid Tumor, Colorectal Cancer
First in Human Study of TORL-3-600 in Participants With Advanced Cancer
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-3-600 in patients with advanced cancer
- Trial name
- NCT05948826
- Testing
- TORL-3-600
- Where
- 9 sites in United States, Canada
- Volunteers
- 70 people
- Sponsor
- TORL Biotherapeutics, LLC
Multiple Myeloma
Study of Oral Ixazomib in Combination With Melphalan and Prednisone in Participants With Newly Diagnosed Multiple Myeloma
The purpose of this phase 1/2, open-label study was to evaluate the effect of oral formulation of Ixazomib when added to standard melphalan and prednisone (MP) treatment.
- Trial name
- NCT01335685
- Testing
- Ixazomib, Melphalan, Prednisone
- Where
- 20 sites in United States, Canada and 3 more
- Volunteers
- 61 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Amenorrhea
Determination of the Lowest, Safe and Effective Dose of Proellex
The purpose of this study is to determine the effects of five different doses of Proellex on menses, ovulation, liver function, and steady state exposure in women of reproductive age.
- Trial name
- NCT01187043
- Testing
- Proellex
- Where
- United States
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Repros Therapeutics Inc.
Systemic Lupus Erythematosus, Lupus
CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy, in Patients With Refractory Systemic Lupus Erythematosus (GALLOP)
This is a Phase 1 study to evaluate the safety and efficacy of a single infusion of CB-010 in patients with refractory Systemic Lupus Erythematosus (SLE) with cohorts for lupus nephritis (LN) and extrarenal lupus (ERL).
- Conditions
- Systemic Lupus Erythematosus, Lupus, Lupus Erythematosus, Lupus Nephritis
- Trial name
- GALLOP (NCT06752876)
- Testing
- CB-010
- Sponsor
- Caribou Biosciences, Inc.
Pitt Hopkins Syndrome
Safety & Efficacy of AlloRx SC® in PTHS Patients
This study will evaluate the safety of AlloRx Stem Cells® in subjects with Pitt Hopkins syndrome ages 2-45 with a molecularly confirmed pathogenic mutation in TCF4 or 18q deletion including TCF4.
- Trial name
- NCT05165017
- Testing
- AlloRx Stem Cells®
- Volunteers
- 26 people
- Sponsor
- Vitro Biopharma Inc.
Pharmacokinetics of ASP015K, Food Effect
A Phase I Study to Compare 3 Different Strengths of an Extended Release Formulation of ASP015K to an Immediate Release Formulation of ASP015K
The purpose of this study is to compare the pharmacokinetics (PK) profiles of three different strengths of ASP015K extended release formulation and an immediate release formulation and to evaluate food effect on extended release…
- Conditions
- Pharmacokinetics of ASP015K, Food Effect, Healthy Volunteers
- Trial name
- NCT01686217
- Testing
- ASP015K ER, ASP015K IR
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Neoplasms
First-in-man Dose Escalation Study of BAY1179470 in Patients With Advanced, Refractory Solid Tumors
An open-label, non-randomized, Phase I dose-escalation study designed to assess the safety, tolerability, pharmacokinetics(PK) /pharmacodynamics( PD) and tumor response profile of BAY1179470 in subjects with advanced, refractory…
- Trial name
- NCT01881217
- Testing
- BAY1179470
- Where
- 8 sites in Japan, Singapore and 1 more
- Volunteers
- 35 people
- Sponsor
- Bayer
Vaginal Atrophy, Vulvar Atrophy
VG101 Phase I/II to Treat Vulvar and Vaginal Atrophy in Post-Menopausal Women
To conduct a prospective, randomized, blinded, placebo controlled, dose escalation clinical trial in 4 cohorts of 10 postmenopausal women (total N=40) aged 45 to 65 years with at least one menopausal vaginal symptom, vaginal pH >…
- Trial name
- NCT00453089
- Testing
- VG101
- Where
- 2 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Bionovo
Safety、Immunogenicity
To Evaluate the Safety and Primary Immunogenicity of Cell-free (Three-component) Combination Vaccine for Phase I Immunogenicity in Children and Infants
A single-center and single-arm design was used to evaluate the safety and preliminary immunogenicity of the adsorbed cell-free leukiche (three-component) combination vaccine.Main purpose: To evaluate the safety of the adsorbed…
- Trial name
- NCT05189548
- Testing
- A single-center and single-arm design was used to evaluate the safety and preliminary immunogenicity of the adsorbed cell-free leukiche (three-component) combination vaccine
- Where
- China
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Changchun BCHT Biotechnology Co.
Cervical Cancer, Cancer
A Study of ADXS11-001 or MEDI4736 Alone or Combination In Cervical or Human Papillomavirus (HPV)+ Head & Neck Cancer
This was a multicenter, open-label, 2-part randomized study of MEDI4736 administered as monotherapy or in combination with ADXS11-001 to participants with recurrent/persistent or metastatic squamous or non-squamous carcinoma of…
- Conditions
- Cervical Cancer, Cancer, Head and Neck Cancer
- Trial name
- NCT02291055
- Testing
- ADXS11-001, MEDI4736
- Where
- 17 sites in United States
- Volunteers
- 75 people
- Sponsor
- Advaxis, Inc.
Tumors
Phase I Study of the Volitinib (HMPL-504) in Patients With Advanced Solid Tumors
The purpose of this study is to evaluate the safety and tolerability of single and multiple doses of volitinib administered to patients with locally advanced or metastatic solid tumors and determine MTD (Maximum Tolerated Dose)…
- Trial name
- HMPL-504 (NCT01985555)
- Testing
- Volitinib(HMPL-504)
- Where
- China
- Volunteers
- 85 people
- Sponsor
- Hutchison Medipharma Limited
Healthy Participants
Comparing the Extent to Which Three Different Formulations of LY4100511 (DC-853) Are Made Available in the Body, Alone and in the Presence of a Drug That Reduces Stomach Acid
The main purpose of this study is to compare the bioavailability of 3 different formulations of LY4100511 and if the use of a proton pump inhibitor (PPI) alters the bioavailability of the 3 different formulations.
- Trial name
- NCT06916143
- Testing
- LY4100511, Rabeprazole
- Where
- 2 sites in United States
- Volunteers
- 1 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
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