Clinical trials: Dose Escalation and Safety
Healthy
A Phase I Study of IDP-73152 Mesylate in Health Male Volunteer
A dose block-randomized, double-blinded, placebo-controlled, single dose, dose-escalation clinical phase I study to evaluate the safety, pharmacokinetics and food effect of IDP-73152 mesylate after oral administration in healthy…
- Trial name
- PDF inhibitor (NCT01904318)
- Testing
- IDP-73152 mesylate 40 mg, IDP-73152 mesylate 80 mg, IDP-73152 mesylate 160 mg
- Where
- South Korea
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- IlDong Pharmaceutical Co Ltd
Advanced or Metastatic Solid Tumours
A Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK127 in Combination With AK104 in Advanced and Metastatic Solid Tumours
A Phase 1 study to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary antitumor activity of AK127 in combination with AK104.
- Trial name
- NCT05021120
- Testing
- AK127, AK104
- Where
- 5 sites in Australia
- Volunteers
- 67 people
- Sponsor
- Akesobio Australia Pty Ltd
VTE Prophylaxis With Anticoagulation After Total Knee Replacement Surgery
A Study to Evaluate the Safety and Efficacy of Intravenous JNJ-64179375 Versus Oral Apixaban in Participants Undergoing Elective Total Knee Replacement Surgery
The primary purpose of Part 1 in this study is to assess the safety and tolerability of JNJ-64179375 for each dose level for dose escalation and any bleeding events (the composite of major, clinically relevant non-major, and…
- Trial name
- TEXT-TKR (NCT03251482)
- Testing
- JNJ-64179375 0.3 mg/kg, JNJ-64179375 0.6 mg/kg, JNJ-64179375 1.2 mg/kg
- Where
- 103 sites in United States, Argentina and 14 more
- Volunteers
- 308 people
- Sponsor
- Janssen Research & Development, LLC
Multiple Myeloma
A Study to Evaluate the Safety and Pharmacokinetics of XMAB24306 in Combination With Daratumumab in Participants With Relapsed/Refractory Multiple Myeloma
This study will evaluate the safety, tolerability, pharmacokinetics, and activity of XmAb24306 in combination with a multiple myeloma (MM)-targeting monoclonal antibody capable of inducing antibody-dependent cellular toxicity…
- Trial name
- NCT05243342
- Testing
- XmAb24306, Daratumumab
- Where
- 7 sites in Australia, Denmark and 2 more
- Volunteers
- 18 people
- Sponsor
- Genentech, Inc.
Acute Ischemic Stroke AIS
The STem Cell-derived Extracellular Vesicle Therapy In Acute Ischemic Stroke (STEVIA)
This is a multicenter open-label, single-arm, dose escalation phase I clinical trial to evaluate the safety and tolerability of SNE-101 in patients with acute ischemic stroke
- Trial name
- STEVIA (NCT06995625)
- Testing
- SNE-101
- Where
- 3 sites in South Korea
- Volunteers
- 18 people
- Sponsor
- S&Ebio Co. Ltd.
Advanced Solid Tumors
An Investigation of TAS-119 Monotherapy
A Phase 1, Open-Label, Non-Randomized, Dose-Escalating Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of TAS-119 in Patients with Advanced Solid Tumors.
- Trial name
- NCT02448589
- Testing
- TAS-119
- Where
- 6 sites in United States, Italy and 3 more
- Volunteers
- 74 people
- Sponsor
- Taiho Oncology, Inc.
Diabetic Macular Edema
A Dose Escalation Study of IBI324 in Subjects With Diabetic Macular Edema
This study is designed as a Multi-center, open-label, dose escalation phase I trial to evaluate the safety and tolerability of a single and multiple intravitreal injections of IBI324 in subjects with DME
- Trial name
- NCT05489718
- Testing
- IBI324
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Cancer
A Phase I Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of of GSK2118436 in Japanese Subjects With BRAF Mutation Positive Solid Tumors
BRF116056 is the first clinical experience with GSK2118436, a BRAF inhibitor, in Japan. This study will be designed to assess safety, tolerability, single and repeat dose PK profile and preliminary efficacy of GSK2118436 in…
- Trial name
- NCT01582997
- Testing
- GSK2118436
- Where
- 2 sites in Japan
- Volunteers
- 12 people
- Sponsor
- GlaxoSmithKline
Hepatitis C, Chronic
Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of Repeat Doses of GSK2878175 in Subjects With Chronic Hepatitis C.
GSK2878175 is a site IV NS5B non-nucleoside inhibitor (NNI) being developed for the treatment of chronic hepatitis C virus (HCV) infection.
- Trial name
- NCT02014571
- Testing
- GSK2878175
- Where
- Puerto Rico
- Volunteers
- 37 people
- Sponsor
- GlaxoSmithKline
Mesothelin-Positive Advanced Solid Tumors With Peritoneal Metastasis
A Study of Mesothelin-Targeted CAR-Mix Cells in Patients With Advanced Solid Tumors
An exploratory, open-label, single-arm, dose-escalation clinical study evaluating the safety, tolerability, pharmacokinetics/pharmacodynamics, and preliminary antitumor activity of intraperitoneally administered SY001…
- Trial name
- NCT07909434
- Testing
- SY001
- Volunteers
- 10 people
- Sponsor
- Zhejiang University
Atopic Dermatitis (AD)
A Phase 1/1b Study to Evaluate Safety, Tolerability and Pharmacokinetics of ZL-1503 in Healthy Volunteers and Participants With Moderate to Severe Atopic Dermatitis
This is a phase 1/1b randomized, double blind, placebo-controlled, single dose escalation (SAD) and multiple dose escalation (MAD) study to evaluate the safety, tolerability, and pharmacokinetics (PK) of ZL-1503 in healthy…
- Trial name
- NCT07235384
- Testing
- ZL-1503
- Where
- 12 sites in Australia, China and 1 more
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Zai Lab (Shanghai) Co., Ltd.
Healthy Volunteers
Single Dose, Dose Escalation Healthy Volunteers Study Of PF-05105679
This is a two part study. The purpose of the first part (Part A) is the evaluation of the pharmacokinetics, safety and tolerability after single ascending dose of PF-05105679.
- Trial name
- SINGLE DOSE (NCT01393652)
- Testing
- PF-05105679
- Where
- Belgium
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Pfizer
Osteoarthritis, Knee
A Phase 1/2A, Single Dose Study Of PF-04383119 In Japanese Patients With Moderate To Severe Pain From Osteoarthritis Of The Knee
To evaluate the safety and tolerability of single IV doses of PF-04383119 in Japanese patients with moderate to severe pain from OA of the knee (Part I).
- Trial name
- NCT00669409
- Testing
- PF-04383119 (tanezumab)
- Where
- 12 sites in Japan
- Volunteers
- 83 people
- Sponsor
- Pfizer
ER+, HER2-, Metastatic Breast Cancer
AZD9833 China PK Study
A Phase 1 Dose Escalation and Expansion Study of AZD9833 Alone or in Combination in Chinese patients with ER Positive, HER2 Negative, Metastatic Breast Cancer
- Trial name
- AZD9833 (NCT04818632)
- Testing
- AZD9833, AZD9833 with palbociclib, AZD9833 with everolimus
- Where
- 4 sites in China
- Volunteers
- 28 people
- Sponsor
- AstraZeneca
Advanced Solid Tumors, Advanced Recurrent Ovarian Tumors
A Study to Evaluate the Safety and Antitumor Activity in Subjects With Advanced Solid Tumors
To determine the maximum tolerated dose or optimal biological dose, and the safety profile of MEDI3617 when given as a single-agent or in combination with other chemotherapeutic agents in subjects with advanced solid malignancies…
- Trial name
- NCT01248949
- Testing
- MEDI3617, Bevacizumab, Paclitaxel
- Where
- 10 sites in United States
- Volunteers
- 162 people
- Sponsor
- MedImmune LLC
Filariasis
Safety, Tolerability and PK of Multiple-ascending Doses of Emodepside
The study evaluates safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of emodepside, after administration as a Liquid Service Formulation (LSF), over 10 days, in healthy male caucasian subjects.
- Trial name
- NCT03383614
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Drugs for Neglected Diseases
Psoriasis
A Multiple Dose Escalation Study of ASKP1240 in Subjects With Moderate to Severe Plaque Psoriasis
The purpose of this study is to explore the safety and tolerability of multiple doses of ASKP1240 compared to placebo and determine Pharmacokinetics and Pharmacodynamics in subjects with moderate to severe psoriasis.
- Trial name
- NCT01585233
- Testing
- ASKP1240
- Where
- 13 sites in Australia, Canada and 1 more
- Volunteers
- 60 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Endometriosis
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of SKI2670
In this Phase I study, the primary objective is to investigate the safety and tolerability of SKI2670 after oral administration in healthy female subjects.
- Trial name
- NCT02202408
- Testing
- SKI2670
- Where
- South Korea
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- SK Chemicals Co., Ltd.
Cerebral Cavernous Malformation
Study to Establish Safety, Tolerability and Pharmacokinetics of NRL-1049 in Healthy Adult Participants Following Multiple-Dose Administration
This Phase 1, dose-escalation, double-blind, multiple ascending dose (MAD) study was designed to assess the safety and tolerability of NRL-1049 compared to placebo in healthy adult participants and to determine the maximum…
- Trial name
- NCT07908134
- Testing
- NRL-1049
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Neurelis, Inc.
Locally Advanced Liver Carcinoma
A Phase 1 Study of BST02 in Treating Locally Advanced Liver Cancer
The goal of this clinical trial is to investigate the BST02, a tumor infiltrating lymphocyte product, collected from the locally advanced liver cancer subjects The main questions it aims to answer are: 1.
- Trial name
- NCT06526832
- Testing
- BST02
- Where
- China
- Volunteers
- 9 people
- Sponsor
- BioSyngen Pte Ltd
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