Clinical trials: Dose Escalation and Safety
Chronic Kidney Diseases
A Study of Patients With Chronic Kidney Disease to Assess the Safety of a Single Dose of COR-001
This is a randomized, double-blind, placebo-controlled trial designed to evaluate the safety, pharmacokinetics, and pharmacodynamic effects of a single dose of the study drug or placebo administered subcutaneously to patients…
- Trial name
- COR-001-SC1 (NCT03126318)
- Testing
- COR-001
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- University of Colorado, Denver
Advanced or Metastatic Solid Tumors
This is an Open Label, Two-part, Multicenter, Phase I Trial to Investigate the Safety, Tolerability, and PK of KGX101 Monotherapy and Combination Therapy With Envafolimab in Patients With Advanced or Metastatic Solid Tumors.
This is an open label, two-part, multicenter, multi-regional phase I trial to investigate the safety, tolerability, and PK of KGX101 monotherapy and combination therapy with Envafolimab in patients with advanced or metastatic…
- Trial name
- NCT06074497
- Testing
- KGX101- Cohort -1, KGX101- Cohort 1, KGX101- Cohort 2
- Where
- 3 sites in Australia
- Volunteers
- 54 people
- Sponsor
- Kangabio AUSTRALIA LTD PTY
Pulmonary Tuberculosis
Phase 1 ID93 + GLA-SE Vaccine Trial in BCG-Vaccinated Healthy Adult Volunteers
The purpose of this study is to determine the safety, tolerability, and immunogenicity in BCG-vaccinated healthy adult subjects of an investigational vaccine being developed for the prevention of pulmonary tuberculosis.
- Trial name
- NCT01927159
- Testing
- ID93 + GLA-SE
- Where
- South Africa
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Access to Advanced Health Institute (AAHI)
Healthy Participants, Narcolepsy
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAK-925 in Healthy Volunteers and Participants With Narcolepsy
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TAK-925 when administered to healthy participants and narcolepsy participants.
- Trial name
- NCT03748979
- Testing
- TAK-925
- Where
- 3 sites in Japan
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Takeda
Neovascular Age-Related Macular Degeneration (nAMD)
Open-laBel Dose-escalation Study for CRISPR/cas13- Rna TargetInG THerapy for the Treatment of Neovascular Age-related Macular Degeneration in Phase I Trial
Age-related macular degeneration (AMD) leads to severe and irreversible vision loss, while neovascular AMD (nAMD) accounts for 80-90% of AMD blindness.
- Trial name
- BRIGHT (NCT06623279)
- Testing
- HG202
- Volunteers
- 15 people
- Sponsor
- HuidaGene Therapeutics Co., Ltd.
Healthy Subjects
GSK1349572 First Time in Human Study
To determine safety, tolerability and pharmacokinetics of GSK1349572
- Trial name
- NCT00555035
- Testing
- GSK1349572
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
A Multiple Dose Study of DWP10292 and UDCA in Healthy Male Subjects
The purpose of this study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of DWP10292 and UDCA in healthy male volunteers after multiple-dosing.
- Trial name
- NCT02622685
- Testing
- DWP10292, Ursodeoxycholic acid (UDCA)
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Advanced Solid Tumours, Breast Cancer
The Safety and Pharmacokinetics of IMP4297 in Patients With Advanced Solid Tumors
This is a phase 1, First-In-Human, open label study, trialing a new PARP (poly-ADP ribose polymerase) inhibitor medication IMP4297 in participants with advanced solid tumour.
- Conditions
- Advanced Solid Tumours, Breast Cancer, Ovarian Cancer, Prostate Cancer
- Trial name
- NCT03507543
- Testing
- IMP4297
- Where
- 3 sites in Australia
- Volunteers
- 39 people
- Sponsor
- Impact Therapeutics, Inc.
Healthy
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple s.c Doses HS-20004 in Healthy Chinese Volunteers
This trial is conducted in China. The aim of this trial is to assess the safety and tolerability for Multiple s.c injection of HS-20004 in healthy Chinese subjects
- Trial name
- NCT02746315
- Testing
- HS-20004
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Acute Myeloid Leukemia (AML)
A Phase Ib Study of CT053PTSA in Relapsed / Refractory Acute Myeloid Leukemia (AML)
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of CT053PTSA in Relapsed/refractory AML patients with FLT3 gene mutation.
- Trial name
- NCT03125876
- Testing
- CT053PTSA
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Gastric Cancer, Triple Negative Breast Cancer
A Study of Niraparib Combined With MGD013 in Patients With Advanced or Metastatic Solid Tumor Who Failed Prior Treatment
This is a a Multicenter, Open-label, Single-arm, Phase Ib Dose Escalation and Multi-cohort Expansion Clinical Study to Assess the Safety and Antitumor Activity of Niraparib in Combination with MGD013 in Patients with Advanced or…
- Conditions
- Gastric Cancer, Triple Negative Breast Cancer, Biliary Tract Carcinoma, Endometrial Carcinoma
- Trial name
- NCT04178460
- Testing
- Niraparib combined with MGD013
- Where
- 19 sites in China
- Volunteers
- 60 people
- Sponsor
- Zai Lab (Shanghai) Co., Ltd.
Neoplasm Malignant
First-in-human Single Agent Study of SAR442257 in RRMM and RR-NHL
Primary Objective: To determine the maximum tolerated dose (MTD) of SAR442257 administered as a single agent in patients with relapsed and refractory multiple myeloma (RRMM) and relapsed and refractory non-Hodgkin lymphoma…
- Trial name
- NCT04401020
- Testing
- SAR442257
- Where
- 16 sites in United States, Czechia and 3 more
- Volunteers
- 47 people
- Sponsor
- Sanofi
Overweight , Obesity
A Study of SRSD384 in Overweight or Obese Participants
This is a two-part study, intended to investigate the safety, tolerability, characteristics of PK and PD of single SC dose of SRSD384 alone in overweight or obese participants (Part A) and in combination with tirzepatide in…
- Trial name
- NCT07557355
- Testing
- SRSD384 injection
- Where
- Australia
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Sirius Therapeutics Co., Ltd.
Advanced Solid Tumors
Study of the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Antitumor Activity of KN046 in Subjects With Advanced Solid Tumors
This is an open-label, multicenter, dose-escalation phase I study to assess the safety, tolerability and preliminary efficacy of KN046 in participants with all advanced solid tumors who are not able to have current standard…
- Trial name
- NCT03529526
- Testing
- KN046
- Where
- Australia
- Volunteers
- 21 people
- Sponsor
- Alphamab (Australia) Co Pty Ltd.
HER2 Positive Breast Neoplasms, Hormone Receptor Positive Breast Neoplasms
A Safety Study of SGN-LIV1A in Breast Cancer Patients
This study will examine the safety and tolerability of ladiratuzumab vedotin (LV) in patients with metastatic breast cancer. LV will be given alone or in combination with trastuzumab.
- Conditions
- HER2 Positive Breast Neoplasms, Hormone Receptor Positive Breast Neoplasms, Triple Negative Breast Neoplasms, HER2 Mutations Breast Neoplasms
- Trial name
- NCT01969643
- Testing
- ladiratuzumab vedotin, Trastuzumab
- Where
- 38 sites in United States
- Volunteers
- 290 people
- Sponsor
- Seagen Inc.
Lymphoma, Advanced Solid Tumors
A Phase I, Study to Evaluate the Safety and Tolerability of Intravenous EZN-2208 in Patients With Advanced Solid Tumors or Lymphoma (EZN-2208-02)
The goal of this clinical research study is to find the highest tolerable dose of EZN-2208 that can be given to patients with advanced cancer or lymphoma.
- Trial name
- NCT00520390
- Testing
- EZN-2208
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Enzon Pharmaceuticals, Inc.
Unspecified Adult Solid Tumor, Protocol Specific
3-Aminopyridine-2-carboxaldehyde Thiosemicarbazone in Treating Patients With Solid Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of 3-aminopyridine-2-carboxaldehyde thiosemicarbazone in…
- Trial name
- NCT00004213
- Testing
- triapine
- Where
- 2 sites in United States
- Sponsor
- Vion Pharmaceuticals
Advanced Solid Tumors
A Study to Evaluate the Safety and Tolerability of Using the SHR-1210 by Advanced Solid Tumor Subjects
This is an open-label, multiple centers, non-randomized, dose escalation phase I trial to evaluate safety and tolerability of SHR-1210 in patients with advanced solid tumors The primary objective is to assess safety and…
- Trial name
- NCT02721589
- Testing
- SHR-1210
- Where
- China
- Volunteers
- 126 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Healthy
Study of CM310 in Healthy Subjects
This is a single center, randomized, double-blind, placebo-controlled, dose escalation study.
- Trial name
- NCT06161090
- Testing
- CM310
- Where
- China
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Keymed Biosciences Co.Ltd
Chemotherapy-induced Peripheral Neuropathy (CIPN)
Safety, Tolerability, and PK of AH-008 Following Single Ascending Dose in Healthy Subjects
This is a Phase 1, first-in-human (FIH), randomized, double-blind, placebo-controlled, parallel-group, single ascending dose (SAD) study to evaluate the safety, tolerability, and pharmacokinetics of AH-008 administered as a…
- Trial name
- NCT07697560
- Testing
- AH-008 for Injection, 150 mg
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- AnHorn Medicines Co. Ltd.
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