Clinical trials: Dose Escalation and Safety
Healthy Subject
A Clinical Trial to Evaluate Tolerability and Pharmacokinetics of HL217 Eye Drop in Healthy Male Subjects
The purpose of this study is to evaluate the safety, tolerability and PK parameters in healthy subjects.
- Trial name
- NCT03650608
- Testing
- Cohort 1: HL217 Ophathalmic Solution QD, Cohort 2: HL217 Ophathalmic Solution BID, Cohort 3: HL217 Ophthalmic Solution QID
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Hanlim Pharm. Co., Ltd.
Advanced Solid Tumor
A Phase I Study to Evaluate the Safety, Pharmacokinetics and Antitumor Activity of HC010 in Patients With Advanced Solid Tumors
This clinical trial is a multicenter, open, single-arm, non-randomized, dose-escalation and dose-expansion, phase I clinical study in patients with advanced recurrent or metastatic solid tumors.The goal of this study is to…
- Trial name
- NCT06307925
- Testing
- HC010
- Where
- China
- Volunteers
- 122 people
- Sponsor
- HC Biopharma Inc.
Advanced Malignancies
Clinical Study of BR105 Injection
A phase 1, dose escalation and dose expansion study of BR105 in patients with advanced malignancies.
- Trial name
- BR105-I (NCT05351697)
- Testing
- BR105 injection
- Where
- China
- Volunteers
- 31 people
- Sponsor
- BioRay Pharmaceutical Co., Ltd.
Erectile Dysfunction
This Study is to Evaluate the Safety and Efficacy of Avanafil in the Treatment of Erectile Dysfunction.
The objective of this study is to evaluate the safety and efficacy of Avanafil in the treatment of erectile dysfunction with moderate to severe in subjects.
- Trial name
- SPEED (NCT01705197)
- Testing
- Avanafil 100 or 200mg
- Where
- South Korea
- Volunteers
- 195 people
- Sponsor
- JW Pharmaceutical
Sickle Cell Disease
A Study to Evaluate Safety, Pharmacokinetic, and Biological Activity of INCB059872 in Subjects With Sickle Cell Disease
The purpose of this study was to evaluate the safety and tolerability, and the pharmacokinetic and biologic activity of INCB059872 in participants with sickle cell disease.
- Trial name
- NCT03132324
- Testing
- INCB059872
- Where
- 7 sites in United States
- Volunteers
- 12 people
- Sponsor
- Incyte Corporation
Advanced or Metastatic Solid Tumors With Homozygous MTAP Deletion
A Phase I Study of SY-9453 in Patients With Advanced Solid Tumors
This is an open-label, single-arm, multicenter, dose-escalation and dose-expansion, phase I study to the safety, tolerability, pharmacokinetics, and preliminary efficacy of SY-9453 in patients with advanced solid tumors.
- Trial name
- NCT07469982
- Testing
- SY-9453
- Where
- China
- Volunteers
- 122 people
- Sponsor
- Shouyao Holdings (Beijing) Co. LTD
Metastatic Pancreatic Cancer
A Study of Galunisertib (LY2157299) and Durvalumab (MEDI4736) in Participants With Metastatic Pancreatic Cancer
The main purpose of this study is to evaluate the safety and efficacy of the study drug known as galunisertib administered in combination with the anti-programmed cell death-ligand 1 (PD-L1) antibody durvalumab in participants…
- Trial name
- NCT02734160
- Testing
- Galunisertib, Durvalumab
- Where
- 11 sites in United States, France and 3 more
- Volunteers
- 37 people
- Sponsor
- Eli Lilly and Company
NF2 Deficiency
Gene Therapy for Neurofibromatosis Type 2 (NF2) with ST002
This is an open-label, single-arm, dose-escalation pilot study to evaluate the safety, tolerability and preliminary efficacy of ST002 in the treatment of patients with NF2 mutation-related solid tumors.
- Trial name
- NCT06834438
- Testing
- ST002
- Where
- China
- Volunteers
- 9 people
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Hodgkin Lymphoma
Study of the Combination of AFM13 and Pembrolizumab in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma
The purpose of this study is to establish a dosing regimen for the combination therapy of AFM13 and pembrolizumab (MK-3475) in patients with relapsed or refractory (R/R) Hodgkin Lymphoma (HL) and to assess the safety and…
- Trial name
- NCT02665650
- Testing
- AFM13, Pembrolizumab
- Where
- 18 sites in United States, Spain
- Volunteers
- 30 people
- Sponsor
- Affimed GmbH
Advanced Malignant Solid Tumours
Aims to Explore the Safety, Tolerability, and Preliminary Efficacy of SCTB14 in Adult Patients With Advanced Malignant Solid Tumours.
This study aims to explore the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor efficacy of SCTB14 as a monotherapy in adult patients with advanced malignant solid tumours.
- Trial name
- NCT06304818
- Testing
- SCTB14
- Volunteers
- 515 people
- Sponsor
- Sinocelltech Ltd.
Advanced Solid Tumors
Study of CHO-A04 in Advanced Solid Tumors
The goal of this clinical trial is to learn if the study drug, CHO-A04, works to treat solid cancers in adults. It will also aim to learn about the safety of CHO-A04 and find the best dose to use in future cancer treatment.
- Trial name
- NCT07049458
- Testing
- CHO-A04
- Where
- Taiwan
- Volunteers
- 62 people
- Sponsor
- Cho Pharma Inc.
Malignant Brain Tumors
Phase I Study of HSK42360 in Malignant Brain Tumors With BRAF V600 Mutation
This is a phase I, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, PK of HSK42360 when given orally in pediatric patients with active BRAF V600 mutation recurrent malignant brain tumors.
- Trial name
- NCT07158710
- Testing
- HSK42360
- Where
- 6 sites in China
- Volunteers
- 159 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Norovirus Infections
A Trial of a Norovirus G1.1 and G2.4 Vaccine Administered Orally to Healthy Participants Aged ≥ 18 Years and ≤ 80 Years Old
The primary objective of this study is to determine the safety and immunogenicity of low and high dose regimens of a next generation norovirus bivalent G1.1 and G2.4 vaccine candidate in healthy participants.
- Trial name
- NCT06944717
- Testing
- VXA-G1.1-NN, VXA-G2.4-NS, VXA G1.1 NN-T
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Vaxart
Chronic Weight Management
A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC47 in Healthy and Obese Subjects
This will be a phase I, randomized, double-blind, placebo-controlled, single dose escalation study. This study will be conducted in three periods: the screening period, the treatment period, and the follow-up period.
- Trial name
- NCT06427590
- Testing
- ASC47
- Where
- Australia
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Ascletis Pharma (China) Co., Limited
Breast Cancer
RAD001 Plus Docetaxel in Patients With Metastatic Breast Cancer
Primary: To assess the safety and tolerability and to find the maximum tolerated dose of the combination administration of RAD001 plus docetaxel when given to patients with metastatic breast cancer who are being considered for…
- Trial name
- NCT00253318
- Testing
- Docetaxel, RAD001, Dexamethasone
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- M.D. Anderson Cancer Center
Advanced Cancer
Safety Study of SGX523, a Small Molecule Met Inhibitor, to Treat Solid Tumors
SGX523 is a drug which acts by blocking the function of an enzyme called MET. MET activity may be important in growth and survival of some types of cancer.
- Trial name
- NCT00606879
- Testing
- SGX523 Capsules
- Where
- 2 sites in United States
- Volunteers
- 46 people
- Sponsor
- SGX Pharmaceuticals, Inc.
Advanced Solid Tumor
Study of LM-302 in Patients With Advance Solid Tumors
A Phase I/II Study of LM-302 in Patients with CLDN18.2-Positive Advanced Solid Tumors
- Trial name
- NCT05161390
- Testing
- LM-302 Injection
- Where
- China
- Volunteers
- 153 people
- Sponsor
- LaNova Medicines Zhejiang Co., Ltd.
Stage III Prostate Carcinoma, Stage IV Prostate Carcinoma
Dose Finding Safety Study of VAL201 in Cancer Patients
Dose finding safety study of VAL201 in cancer patients.
- Trial name
- VAL201-001 (NCT02280317)
- Testing
- VAL201
- Volunteers
- 12 people
- Sponsor
- ValiRx Plc
Tuberculosis
Study of AERAS 422 in Healthy Adults
The purpose of this study is to evaluate the safety and immunogenicity of AERAS-422 in healthy, BCG-naïve adults.
- Trial name
- NCT01340820
- Testing
- AERAS-422, BCG Tice
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Aeras
Bacterial Infections
Study of the Safety and Pharmacokinetics of KSP-1007 Alone and Coadministered With Meropenem in Healthy Subjects
This study is a first-in-human, Phase 1, randomized, double- blind, four-part, dose-escalation study to assess the safety, tolerability, and pharmacokinetics of single (Part 1) and repeat (Part 2) escalating intravenous doses of…
- Trial name
- NCT05226923
- Testing
- KSP-1007, Meropenem
- Where
- United States
- Volunteers
- 123 people, healthy volunteers welcome
- Sponsor
- Sumitovant Biopharma, Inc.
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