Clinical trials: Dose Escalation and Safety
Spinal Muscular Atrophy (SMA)
A Study of the Safety and Preliminary Efficacy of NKG001 in Pediatric Patients With Type 1 or Type 2 Spinal Muscular Atrophy
This study is a single-center, open-label, single-arm, non-randomized, single-dose, dose-escalation investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, and preliminary efficacy of NKG001 Injection…
- Trial name
- NCT07617779
- Testing
- NKG001
- Where
- China
- Volunteers
- 21 people
- Sponsor
- Nikegen Pharmaceutical (Hangzhou) Company Limited
Hypertension
A Study on the Efficacy and Safety of Nebivolol Monotherapy in Hispanic Hypertensive Patients
This study will evaluate the efficacy and safety of nebivolol monotherapy in Hispanic patients with stage 1 or stage 2 hypertension
- Trial name
- NCT00770861
- Testing
- Nebivolol
- Where
- 32 sites in United States, Puerto Rico
- Volunteers
- 277 people
- Sponsor
- Forest Laboratories
Critical Limb Ischemia
A Safety and Tolerability Study of RJX Drug Product in Healthy Participants
Designed as a single center, two-part, double-blind, placebo-controlled, randomized study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of RJX in healthy participants.
- Trial name
- NCT03680105
- Testing
- RJX
- Where
- United States
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Reven Pharmaceuticals, Inc.
Metastatic Pancreatic Ductal Adenocarcinoma
A Study of the Safety and Tolerance of CAN04 in Combination With FOLFIRINOX in Subjects With Metastatic Pancreatic Ductal Adenocarcinoma
This study will consider the safety and effectiveness of a study drug, CAN04, in combination with FOLFIRINOX, in the treatment of metastatic pancreatic ductal adenocarcinoma.
- Trial name
- CAPAFOUR (NCT04990037)
- Testing
- CAN04, FOLFIRINOX
- Where
- 9 sites in France, Spain
- Volunteers
- 25 people
- Sponsor
- Cantargia AB
SHANK3 Haploinsufficiency, Phelan-McDermid Syndrome
JAG201 Gene Therapy Study in Children & Adults With SHANK3 Haploinsufficiency
This is a Phase 1/2, first in human, open-label, dose-escalation study to evaluate the safety, tolerability, and clinical activity of a single dose of JAG201 administered via intracerebroventricular (ICV) injection in pediatric…
- Trial name
- NCT06662188
- Testing
- JAG201
- Where
- 3 sites in United States
- Volunteers
- 6 people
- Sponsor
- Jaguar Gene Therapy, LLC
Solid Tumor
A Dose-Escalation Study of GDC-0994 in Patients With Locally Advanced or Metastatic Solid Tumors
This is an open-label, multicenter, dose-escalation study to assess the safety, tolerability, and pharmacokinetics of GDC-0994 in patients with locally advanced or metastatic solid tumors.
- Trial name
- NCT01875705
- Testing
- GDC-0994
- Where
- 4 sites in United States, France
- Volunteers
- 40 people
- Sponsor
- Genentech, Inc.
Advanced Solid Tumors
Safety, Tolerability, Pharmacokinetics, and Antitumor Study of ADCT-601 to Treat Advanced Solid Tumors
This study evaluates the safety, tolerance, pharmacokinetics (PK), and antitumor activity of ADCT-601 in patients with advanced solid tumors.
- Trial name
- NCT03700294
- Testing
- ADCT-601
- Where
- 4 sites in United States
- Volunteers
- 18 people
- Sponsor
- ADC Therapeutics S.A.
Neoplasms, Non-small-cell Lung Cancer
A Study to Learn About How Different Amounts of the Study Medicine PF-07826390 Act in the Body of People With Cancer When Taken Alone or With Other Anti-cancer Medicines.
The purpose of this study is to learn about the: safety (the effect of the study medicine on the participant's body), effects of the study medicine alone or in combination with sasanlimab - the best amount of the study medicine.
- Conditions
- Neoplasms, Non-small-cell Lung Cancer, Squamous Cell Carcinoma of the Head and Neck, Renal Cell Carcinoma
- Trial name
- NCT06546553
- Testing
- PF-07826390, sasanlimab, SOC (anti-PD-1 + platinum -based chemo)
- Where
- 8 sites in United States
- Volunteers
- 10 people
- Sponsor
- Pfizer
Limb Girdle Muscular Dystrophy, Limb-Girdle Muscular Dystrophy Type 2
A Study to Evaluate the Safety of AB-1003 (Previously LION-101) in Subjects With Genetic Confirmation of LGMD2I/R9 (Part1)
The purpose of this study is to evaluate the safety and tolerability of a single intravenous infusion of AB-1003 in adults diagnosed with limb girdle muscular dystrophy type 2I/R9 (LGMD2I/R9).
- Conditions
- Limb Girdle Muscular Dystrophy, Limb-Girdle Muscular Dystrophy Type 2, LGMD2I, Muscular Dystrophy
- Trial name
- NCT05230459
- Testing
- AB-1003 dose level 1, AB-1003 dose level 2
- Where
- 6 sites in United States
- Volunteers
- 9 people
- Sponsor
- AskBio Inc
Diffuse Large B-Cell Lymphoma, B-cell Malignancies
A Study Investigating the Safety and How the Trispecific T-Cell Engaging Antibody BG-T0920 Works in Adults With Diffuse Large B-cell Lymphoma (DLBCL) and Other Aggressive B-Cell Malignancies
The purpose of this study is to test the safety and tolerability of BG-T0920 and to identify the recommended dose and dosing schedule (including dose levels and timing) that can be taken without having serious side effects in…
- Trial name
- NCT07887646
- Testing
- BG-T0920
- Volunteers
- 70 people
- Sponsor
- BeOne Medicines
Healthy Volunteer
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MRG-110 Following Intradermal Injection in Healthy Volunteers
MRG-110 is intended to promote the growth of new blood vessels by inhibiting a molecule called miR-92a. MRG-110 is being studied to determine if it can accelerate healing of wounds by improving blood flow into the wound area.
- Trial name
- NCT03603431
- Testing
- MRG-110
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- miRagen Therapeutics, Inc.
Malaria, Malaria, Cerebral
Study of the Safety of Intravenous Artesunate
The purpose of this study is to establish the safety, tolerability and pharmacokinetics of a single dose of the antimalarial drug artesunate.
- Trial name
- NCT00292929
- Testing
- Intravenous artesunate
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
Advanced or Metastatic Solid Tumors
DCSZ11 as a Monotherapy and in Combination in Patients With Advanced or Metastatic Solid Tumors
This is a multicenter, open-label, Phase 1 study to assess the effects of DCSZ11 as a monotherapy and in combination in patients with advanced or metastatic solid tumors.
- Trial name
- NCT05785754
- Testing
- DCSZ11, Pembrolizumab, Doxorubicin
- Where
- 35 sites in United States, Australia and 2 more
- Volunteers
- 320 people
- Sponsor
- DynamiCure Biotechnology
Stroke
Capsaicin for Cerebral Perfusion Augmentation.
To determine the safety and effect of crescent doses of capsaicin upon serial transcranial Doppler (TCD) markers of cerebral blood flow (CBF).
- Trial name
- NCT04545892
- Testing
- Capsaicin
- Where
- Mexico
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Juan Manuel Marquez Romero
Tumors, Hypoxia
A Phase I Study of the Safety, Pharmacokinetics, and Anti-Tumor Activity of TH-302 in Patients With Advanced Solid Tumors
This is a phase I, multi-center, open-label, dose-escalation study of TH-302 in patients with advanced solid tumors. TH-302 is a hypoxia activated product designed to exploit the hypoxic nature of tumors.
- Trial name
- NCT00495144
- Testing
- TH-302
- Where
- 7 sites in United States
- Volunteers
- 129 people
- Sponsor
- Threshold Pharmaceuticals
Group A Streptococcal Infection
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-A1 in Healthy Young Adults
This is a phase 1, first-in-human, randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability, and immunogenicity of VAX-A1 in healthy adults 18-40 years of age.
- Trial name
- NCT07616934
- Testing
- VAX-A1 Low, VAX-A1 Mid, VAX-A1 High
- Where
- Australia
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Vaxcyte, Inc.
Glioblastoma Multiforme
A Study Evaluating Temferon in Patients With Glioblastoma & Unmethylated MGMT
This is a non-randomized, open label, phase I/IIa, dose-escalation study, involving a single injection of Temferon, an investigational advanced therapy consisting of autologous CD34+-enriched hematopoietic stem and progenitor…
- Trial name
- TEM-GBM (NCT03866109)
- Testing
- Temferon
- Where
- 3 sites in Italy
- Volunteers
- 25 people
- Sponsor
- Genenta Science
Gaucher Disease
A Study of the Tolerability, Safety, and Pharmacokinetics of ISU302 in Healthy Volunteers
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of single dosing study with three ascending dose cohorts of ISU302 in healthy subjects.
- Trial name
- NCT01881633
- Testing
- ISU302
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- ISU Abxis Co., Ltd.
Hereditary Angioedema, HAE
A Gene Therapy Study of BMN 331 in Subjects With Hereditary Angioedema
This is a Phase 1/2, single-arm, open-label, dose-escalation and dose-expansion study of BMN 331 for the treatment of hereditary angioedema (HAE) due to C1 Esterase Inhibitor (C1-INH) protein deficiency.
- Trial name
- HAErmony-1 (NCT05121376)
- Testing
- Dose 1 of BMN 331, Dose 2 of BMN 331, Dose 3 of BMN 331
- Where
- 16 sites in United States, Australia and 1 more
- Volunteers
- 44 people
- Sponsor
- BioMarin Pharmaceutical
Cancer
A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Anti-Cancer Activity of Trametinib in Combination With Palbociclib in Subjects With Solid Tumors
This is a dose-escalation, Phase I/II, open-label, three-part study. Part 1 is designed to determine the recommended dose and schedule for the orally administered MEK inhibitor trametinib, given together with the CDK4/6 inhibitor…
- Trial name
- NCT02065063
- Testing
- Trametinib, Palbociclib
- Where
- 3 sites in United States
- Volunteers
- 28 people
- Sponsor
- GlaxoSmithKline
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