Clinical trials: Dose Escalation and Safety
Asthma
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Inhaled Montelukast (MK-0476) in Participants With Mild or Moderate Asthma (MK-0476-380 AM3)(COMPLETED)
A study to evaluate the safety, tolerability and pharmacokinetics of inhaled Montelukast (MK-0476) in participants with mild or moderate asthma.
- Trial name
- NCT00636207
- Testing
- Montelukast
- Volunteers
- 46 people
- Sponsor
- Organon and Co
Heart Failure
Study to Evaluate the Effects of TRV120027 in Patients With Heart Failure
In this study, TRV120027 (or a placebo) intravenous infusion will be given to people with heart failure to learn about the effects of TRV120027.
- Trial name
- NCT01187836
- Testing
- TRV120027
- Where
- 9 sites in United States, Czechia and 1 more
- Volunteers
- 33 people
- Sponsor
- Trevena Inc.
Stargardt Disease
Phase 1/2 Open-Label Dose-Escalation Study to Evaluate Safety of a Single Intravitreal Injection of RTx-021 in Patients With Stargardt Disease
A Phase 1/2, open-label, non-randomized, dose-escalation study, where a minimum of 9 and a maximum of 18 eligible patients with Stargardt Disease will be enrolled sequentially in up to 3 dose cohorts of RTx-021.
- Trial name
- AURORA (NCT07439887)
- Testing
- RTx-021
- Where
- 3 sites in United States
- Volunteers
- 18 people
- Sponsor
- Ray Therapeutics, Inc.
Cancer
Study of CGC-11047 When Used in Individual Combinations With 1) Gemcitabine or 2) Docetaxel or 3) Bevacizumab or 4) Erlotinib or 5) Cisplatin or 6) 5-Flurouracil or 7) Sunitinib in Patients With Advanced Solid Tumors or Lymphoma
This study will aims to determine the maximum tolerated dose of CGC-11047 when used in individual combinations with gemcitabine, or docetaxel, or bevacizumab, or erlotinib or cisplatin or 5-flurouracil or sunitinib in one of 7…
- Trial name
- NCT00705874
- Testing
- CGC-11047 and gemcitabine, CGC-11047 and docetaxel, CGC-11047 and bevacizumab
- Where
- 12 sites in United States
- Volunteers
- 172 people
- Sponsor
- Progen Pharmaceuticals
Prostatic Neoplasms
CP-675,206 With Neoadjuvant Hormone Therapy in Patients With High Risk Prostate Cancer
This is a multi-center, open label, randomized study. Patients will be randomized to one of the following arms with an allocation ratio of 3:1, respectively: Arm A: CP-675,206 + neoadjuvant hormone therapy (NHT) OR Arm B…
- Trial name
- NCT00075192
- Testing
- CP-675,206 and leuprolide acetate and bicalutamide, leuprolide acetate and bicalutamide
- Where
- 11 sites in United States
- Volunteers
- 8 people
- Sponsor
- AstraZeneca
Myelodysplastic Syndromes, Leukemia, Myelomonocytic, Chronic
Phase I Dose Escalation Trial of Volasertib in Combination With Azacitidine in Patients With MDS or CMML
To investigate the maximum tolerated dose (MTD), safety, pharmacokinetics, and efficacy of volasertib in combination with azacitidine in patients with myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML) and…
- Trial name
- NCT01957644
- Testing
- Azacitidine, Volasertib
- Where
- 14 sites in France, Germany
- Volunteers
- 16 people
- Sponsor
- Boehringer Ingelheim
Tuberculosis
MTBVAC Study in Adults With and Without Latent Tuberculosis Infection in South Africa
MTBVAC at four dose levels: 5 x 10^3 CFU, 5 x 10^4 CFU, 5 x 10^5 CFU, and 5 x 10^6 CFU. The active control is BCG (5 x 10^5 CFU).
- Trial name
- A-050 (NCT02933281)
- Testing
- MTBVAC, BCG
- Where
- South Africa
- Volunteers
- 144 people, healthy volunteers welcome
- Sponsor
- International AIDS Vaccine Initiative
Covid19
Safety and Immunogenicity Study of AdCLD-CoV19-1: A COVID-19 Preventive Vaccine in Healthy Volunteers
This is a Phase 1 clinical trial to assess the safety and immunogenicity of AdCLD-CoV19-1 in healthy adults.
- Trial name
- NCT05047692
- Testing
- AdCLD-CoV19-1
- Where
- 3 sites in South Korea
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Cellid Co., Ltd.
Tuberculosis
Dose-escalation Safety and Immunogenicity Study to Compare MTBVAC to BCG in Newborns With a Safety Arm in Adults
Randomized, controlled, double blind clinical trial in 2 stages (adult stage, infant stage). The first stage includes 18 HIV uninfected, QFT negative, BCG vaccinated, adult participants, randomized 1:1 to receive BCG Vaccine SSI…
- Trial name
- MTBVAC-Ph1b (NCT02729571)
- Testing
- MTBVAC, BCG
- Where
- South Africa
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Biofabri, S.L
Healthy
A Study In Healthy People To Evaluate Safety, Toleration, Pharmacokinetics And Pharmacodynamics Of Multiple Oral Doses Of PF-06743649
The purpose of this study in healthy people is to evaluate safety, toleration and time course of plasma concentration of multiple oral doses of PF-06743649. The pharmacodynamic activity of PF-06743649 will also be assessed.
- Trial name
- NCT02151617
- Testing
- PF-06743649
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Pfizer
Rett Syndrome
A Safety Study of NNZ-2566 in Patients With Rett Syndrome
The purpose of this study is to determine whether NNZ-2566 is safe and well tolerated in the treatment of Rett Syndrome in adolescent and adult females.
- Trial name
- NCT01703533
- Testing
- NNZ-2566
- Where
- 3 sites in United States
- Volunteers
- 67 people
- Sponsor
- Neuren Pharmaceuticals Limited
Non Hodgkin Lymphoma
A Study of ONO-7018 in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma
ONO-7018 is a selective inhibitor of mucosa associated lymphoid tissue protein 1 (MALT1) and is expected to exhibit antitumor activity in NHL.
- Trial name
- NCT06622226
- Testing
- ONO-7018
- Where
- 6 sites in Japan
- Volunteers
- 2 people
- Sponsor
- Ono Pharmaceutical Co., Ltd.
Relapsed/Refractory Acute Myeloid Leukemia
Study Evaluating Safety and Efficacy of UCART123v1.2 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Phase I, open-label, dose-escalation and dose-expansion study evaluating the safety and efficacy of Universal Chimeric Antigen Receptor T-cell (UCART) targeting the Cluster of Differentiation 123 (CD123) in patients with…
- Trial name
- AMELI-01 (NCT03190278)
- Testing
- UCART123v1.2
- Where
- 8 sites in United States
- Volunteers
- 29 people
- Sponsor
- Cellectis S.A.
Anesthesia, Sedation
A Study Evaluating Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Single IV Dose of HSK3486 Injectable Emulsion in Healthy Subjects.
his single-center, open-label, uncontrolled, and dose-escalation study evaluated the safety, tolerability, and pharmacokinetics/pharmacodynamics of single IV dose of HSK3486 injectable emulsion in healthy subjects.
- Trial name
- NCT03773835
- Testing
- HSK3486
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Sichuan Haisco Pharmaceutical Group Co., Ltd
Healthy Volunteers
A Phase 1 Single-Dose Escalation Study of PF-04308515 in Healthy Volunteers
The purpose of this study is to determine the safety, tolerability, pharmacokinetics (understanding how a drug is absorbed and moves through the body) and pharmacodynamics (understanding the effects of a drug on certain target…
- Trial name
- NCT00990015
- Testing
- PF-04308515
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Pfizer
Non-Hodgkin Lymphoma, Burkitt's Lymphoma
Study of ADCT-402 in Patients With Relapsed or Refractory B-cell Lineage Non Hodgkin Lymphoma (B-NHL)
This study evaluates ADCT-402 in participants with Relapsed or Refractory B-cell Lineage Non Hodgkin Lymphoma (B-NHL). Participants will participate in a dose escalation phase (Part 1) and dose expansion (Part 2).
- Conditions
- Non-Hodgkin Lymphoma, Burkitt's Lymphoma, Chronic Lymphocytic Leukemia, Lymphoma, Large B-Cell, Diffuse
- Trial name
- NCT02669017
- Testing
- ADCT-402
- Where
- 11 sites in United States, Italy and 1 more
- Volunteers
- 183 people
- Sponsor
- ADC Therapeutics S.A.
Bladder Cancer
Clinical Study of T3011 Intravesical Instillation for Treatment of NMIBC Patients
This is a prospective, open-label, single-arm investigator-initiated clinical study. It is used to evaluate the safety and efficacy of T3011 intravesical instillation in patients with BCG-failure high-risk non-muscle invasive…
- Trial name
- NCT06427291
- Testing
- Herpes virus T3011 injection
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Fudan University
Mucopolysaccharidosis II
Safety and Efficacy of HMI-203 in ERT-Treated Adults With MPS II
Phase 1, open-label, sequential ascending dose-escalation study. Designed to evaluate the safety and efficacy of a single IV infusion of investigational gene therapy HMI-203.
- Trial name
- NCT05238324
- Testing
- Genetic HMI-203
- Where
- 6 sites in United States, Canada
- Sponsor
- Homology Medicines, Inc
Advanced Solid Tumor, Advanced or Metastatic Non-small Cell Lung Cancer
Phase I Study of the BBP-398 in Patients With Advance Solid Tumors
This is an open label, dose escalation and expansion, two-part Phase I study for SHP-2 inhibitor BBP-398 to evaluate the safety, tolerability, pharmacokinetics, determine MTD and/or RP2D, and preliminary anti- cancer activity in…
- Trial name
- NCT05621525
- Testing
- BBP-398
- Where
- 2 sites in China
- Volunteers
- 7 people
- Sponsor
- LianBio LLC
Claudin18.2 Positive Advanced Solid Tumors
Treating Claudin18.2-positive Advanced Solid Tumors with XKDCT225(Targeting Claudin18.2-CAR-T)
A single-center, single-arm, dose-escalation exploratory clinical trial of the safety, efficacy, and pharmacokinetics of XKDCT225 cell injection in Claudin18.2-positive advanced solid tumors
- Trial name
- NCT06782425
- Testing
- XKDCT225
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Shenzhen Celconta Life Science Co., Ltd.
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