Clinical trials: Phase I
Advanced Solid Tumors
A Study to Evaluate the Effect of Itraconazole and Rifampin on the Pharmacokinetics of Talazoparib in Patients With Advanced Solid Tumors
This is a study in patients with advanced solid tumors for the investigation of P-gp inhibition and induction on the PK of talazoparib.
- Trial name
- NCT03077607
- Testing
- Talazoparib, Itraconazole, Rifampin
- Where
- 7 sites in Hungary, Moldova and 2 more
- Volunteers
- 36 people
- Sponsor
- Pfizer
Covid19, SARS CoV 2 Infection
Safety and Immunogenicity Study of Recombinant Protein RBD Candidate Vaccine Against SARS-CoV-2 in Adult Healthy Volunteers (COVID-19)
This is a first-in-human, phase I/IIa, randomized, controlled, observer-blinded, dose-escalation, multicentre clinical trial to evaluate safety and immunogenicity of COVID-19 HIPRA vaccine in adult healthy volunteers.
- Trial name
- NCT05007509
- Testing
- COVID-19 vaccine HIPRA 10, COVID-19 vaccine HIPRA 20, COVID-19 vaccine HIPRA 40
- Where
- 2 sites in Spain
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Laboratorios Hipra, S.A.
Brain Tumor
Blood Brain Barrier (BBB) Disruption Using Exablate Focused Ultrasound With Doxorubicin for Treatment of Pediatric Diffuse Intrinsic Pontine Gliomas (DIPG)
The purpose of this study is to evaluate the safety and efficacy of targeted blood brain barrier disruption with Exablate Model 4000 Type2.0/2.1 in combination with Doxorubicin therapy for the treatment of DIPG in pediatric…
- Trial name
- NCT05630209
- Testing
- Exablate, Doxorubicin
- Where
- 3 sites in United States
- Volunteers
- 10 people
- Sponsor
- InSightec
Drug Drug Interaction
Drug-Drug Interaction (DDI) Study in Healthy Volunteers
A Phase 1, Open Label, Fixed Sequence Study to Evaluate the Effect of BLD-0409 on the Single Dose Pharmacokinetics of a Cocktail of Probe Substrates for CYP450 Enzymes in Healthy Volunteers
- Trial name
- NCT04814498
- Testing
- Geneva Cocktail, BLD-0409
- Where
- Australia
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Blade Therapeutics
Healthy, PK Drug-drug Interaction Study
Study to Investigate the Safety, Tolerability and Pharmacokinetics of QEV-817 Oral Suspension
This study has been designed to assess the safety, tolerability, and pharmacokinetics of a therapeutic dose of hydrocodone bitartrate with and without an oral dose of doxapram hydrochloride in healthy volunteers who are…
- Trial name
- NCT06585163
- Testing
- Hydrocodone Bitartrate, Hydrocodone Bitartrate + Doxapram Hydrochloride
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Quivive Pharma, Inc.
Ovarian Cancer, Breast Cancer
A Phase 1 Study of LNCB74 in Advanced Solid Tumors
This is an open-label, phase 1, dose escalation and dose expansion study to determine safety and tolerability, and to determine the maximum tolerated dose and / or recommended phase 2 dose of LNCB74 in participants with advanced…
- Conditions
- Ovarian Cancer, Breast Cancer, Endometrial Cancer, Non-Small Cell Lung Cancer
- Trial name
- LNCB74-01 (NCT06774963)
- Testing
- LNCB74
- Where
- 17 sites in United States
- Volunteers
- 145 people
- Sponsor
- LigaChem Biosciences, Inc.
Hepatic Impairment, Healthy Volunteers
A Study of TAK-279 in Adults With or Without Liver Damage
The main aim of this study is to find out how the body processes 1 dose of TAK-279 (pharmacokinetics) in participants with liver problems compared to participants without liver problems.
- Trial name
- NCT05976321
- Testing
- TAK-279
- Where
- 4 sites in United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Takeda
Healthy Volunteers
A Study of FB1003 in Healthy and Osteoarthritis Pain Subjects
The purpose of Part 1 is to evaluate safety and tolerability of FB1003 when given subcutaneously to healthy participants. Blood tests will be done to examine blood exposure, concentration and half-life of FB1003 following…
- Trial name
- NCT06343714
- Testing
- FB1003
- Where
- 2 sites in Australia
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- 4B Technologies Limited
Type 2 Diabetes
Safety and Pharmacokinetics Study of XOMA 052 in Subjects With Type 2 Diabetes Mellitus
The purpose of this study is to evaluate the safety and pharmacokinetics (PK) of XOMA 052 in subjects with stable Type 2 Diabetes Mellitus (T2D).
- Trial name
- NCT00513214
- Testing
- XOMA 052
- Where
- 4 sites in United States
- Volunteers
- 68 people
- Sponsor
- XOMA (US) LLC
Locally Advanced or Metastatic Solid Tumors, Non-small Cell Lung Cancer
HLX301 (TIGIT×PDL1 Bispecific) in Patients With Locally Advanced or Metastatic Solid Tumors
This Phase 1/2, multicenter, first-in-human, open-label, dose-escalation, dose expansion, and clinical expansion study will evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor efficacy of HLX301…
- Trial name
- NCT05102214
- Testing
- HLX301
- Where
- 5 sites in Australia
- Volunteers
- 150 people
- Sponsor
- Shanghai Henlius Biotech
Renal Impairment
A Study to Investigate the Effect of Renal Impairment on the Pharmacokinetics and Safety of VIR-2218
The rationale of this study is to evaluate the impact of renal function on the PK, safety, and tolerability of VIR-2218 in participants with normal renal function and participants with varying degrees of renal dysfunction who are…
- Trial name
- NCT05844228
- Testing
- VIR-2218
- Where
- 3 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Vir Biotechnology, Inc.
Atopic Dermatitis
A Single-center, Randomized, Double-blinded, Placebo-controlled, Phase 1 Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of NCP112
To evaluate safety, tolerability and pharmacokinetics of NCP 112 after single and multiple applications on the skin of healthy male volunteers.
- Trial name
- NCT05638165
- Testing
- NCP112
- Where
- South Korea
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- NovaCell Technology Inc.
Skin Roughness, Wrinkle
A Phase I Study of KB301, a Replication-Incompetent, Non-Integrating Vector Expressing Human Type III Collagen (COL3) for the Treatment of Superficial Skin Depressions
A Phase I Study of KB301, a Replication-Incompetent, Non-Integrating Vector Expressing Human Type III Collagen (COL3) for the Treatment of Superficial Skin Depressions
- Conditions
- Skin Roughness, Wrinkle, Fine Lines, Skin Thickness
- Trial name
- NCT04540900
- Testing
- KB301
- Where
- 4 sites in United States
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- Krystal Biotech, Inc.
Solid Tumor, Lymphoma
Study of MK-2118 Administered as Intratumoral Injection as Monotherapy and in Combination With Pembrolizumab (MK-3475) or by Subcutaneous Injection in Combination With Pembrolizumab in the Treatment of Adults With Advanced/Metastatic Solid Tumors or Lymphomas (MK-2118-001)
The purposes of this study are to: 1) assess the safety and tolerability and 2) establish a preliminary recommended Phase 2 dose (RP2D) and/or a maximum tolerated dose (MTD) or a maximum administered dose (MAD) of MK-2118 when…
- Trial name
- NCT03249792
- Testing
- MK-2118 (IT), MK-2118 (SC), Pembrolizumab
- Where
- 8 sites in United States, Israel
- Volunteers
- 140 people
- Sponsor
- Merck Sharp & Dohme LLC
Graft Versus Host Disease
Intravenous Administration of RGI-2001 in Patient Undergoing Allogenic Hematopoietic Stem Cell Transplantation (AHSCT)
The clinical trial is a Phase 1/2a, open-label, multi-center, dose-escalation study to evaluate the safety, tolerability and pharmacokinetic profile of RGI-2001 in patients undergoing AHSCT, with radiation or non-radiation…
- Trial name
- NCT01379209
- Testing
- RGI-2001, Calcineurin Inhibitors, Allogeneic Hematopoietic Stem Cell Transplantation
- Where
- 6 sites in United States
- Volunteers
- 68 people
- Sponsor
- Regimmune Corporation
Healthy Volunteer
A Phase 1 SAD/MAD Study of RLS-0071 in Healthy Volunteers in Support of a COVID-19 Development Program
This is a Phase 1, single-center, randomized, double-blind, placebo-controlled, adaptive-design study to assess the safety, tolerability, PK, and PD of single- and multiple-ascending doses of RLS-0071 in healthy adult subjects.
- Trial name
- NCT05298787
- Testing
- RLS-0071
- Where
- Canada
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- ReAlta Life Sciences, Inc.
Healthy
A Drug Drug Interaction (DDI) Study of Pirtobrutinib (LY3527727) and Rosuvastatin in Healthy Participants
The main purpose of this study is to determine the effect of pirtobrutinib on the levels of rosuvastatin in the blood stream in healthy participants.
- Trial name
- NCT05176314
- Testing
- Rosuvastatin, Pirtobrutinib
- Where
- 2 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Loxo Oncology, Inc.
Age-related Macular Degeneration
QA102 Phase 1 Study in Healthy Young and Older Adult Subjects
This will be a double masked, randomized, placebo controlled, single and multiple oral dose study conducted in 3 parts. The safety and tolerability of single and multiple ascending oral doses of QA102 in healthy young and older…
- Trial name
- NCT04894071
- Testing
- QA102
- Where
- United States
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Smilebiotek Zhuhai Limited
Breast Cancer
A Study of Giredestrant (GDC-9545) in Postmenopausal Women With Stage I-III Operable, Estrogen Receptor-Positive Breast Cancer
This study will evaluate the pharmacodynamics, pharmacokinetics, safety, and biologic activity of giredestrant in participants with Stage I-III operable estrogen receptor (ER)-positive, human epidermal growth factor receptor 2…
- Trial name
- NCT03916744
- Testing
- Giredestrant, Surgery
- Where
- 15 sites in United States, Australia and 3 more
- Volunteers
- 75 people
- Sponsor
- Genentech, Inc.
Healthy Volunteers
Safety and Immunogenicity of AdCOVID in Healthy Adults (COVID-19 Vaccine Study)
A study to evaluate the immune response and safety of AdCOVID administered as an intranasal spray in healthy adults.
- Trial name
- NCT04679909
- Testing
- AdCOVID
- Where
- 6 sites in United States
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- Altimmune, Inc.
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