Clinical trials: Dose Escalation and Safety
Solid Tumor
A Phase I Study of IBI325 in Patients With Advanced Solid Tumor
The primary objective of this phase I study is to evaluate the safety and potential efficacy and to determine the recommended phase 2 dose (RP2D) of IBI325 in patients with advanced solid tumors
- Trial name
- NCT05119998
- Testing
- IBI325 + sintilimab, IBI325
- Where
- China
- Volunteers
- 48 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Polycystic Ovary Syndrome
A Study of Safety and Efficacy of Tildacerfont in Females With Polycystic Ovary Syndrome and Elevated Adrenal Androgens
An investigation of the safety and efficacy of tildacerfont in women with PCOS and elevated adrenal androgens
- Trial name
- NCT05370521
- Testing
- Tildacerfont
- Where
- 21 sites in United States
- Volunteers
- 27 people
- Sponsor
- Spruce Biosciences
Advanced / Metastatic Solid Tumor
A Study of SR-8541A (ENPPI Inhibitor) in Advanced/Metastatic Solid Tumors
This is an open-label, dose-escalation, multi-center phase 1 study evaluating the safety, tolerability, and pharmacokinetics (PK) of SR-8541A administered orally as a monotherapy or in combination with an immune checkpoint…
- Trial name
- NCT06063681
- Testing
- SR-8541A, Immune checkpoint inhibitor (ICI)
- Where
- 3 sites in Australia
- Volunteers
- 25 people
- Sponsor
- Stingray Therapeutics
HER2-positive Breast Cancer, HER2-positive Gastric Cancer
A Safety and Activity Study of SBT6050 in Combination With Other HER2-directed Therapies for HER2-positive Cancers
This study is designed to assess the safety and preliminary activity of SBT6050 in combination with trastuzumab deruxtecan (Part 1) or tucatinib plus trastuzumab +/- capecitabine (Part 2).
- Conditions
- HER2-positive Breast Cancer, HER2-positive Gastric Cancer, HER2-positive Colorectal Cancer, HER2-expressing Non-small Cell Lung Cancer
- Trial name
- NCT05091528
- Testing
- SBT6050, trastuzumab deruxtecan, tucatinib
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Silverback Therapeutics
Obesity
Safety, Tolerability and Efficacy Study of PP1420 in HV
Obesity is a growing pandemic which affects 1 in 4 adults in the UK, and shortens life by increasing cardiovascular disease, diabetes and cancer.
- Trial name
- PP14201b1c (NCT02221765)
- Testing
- PP1420
- Where
- United Kingdom
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Imperial College London
Prevention of Arterial and Venous Thrombosis
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of Single-dose Injection of SHR-2004 in Healthy Subjects
The primary objective of this study is to assess the safety and tolerability of SHR-2004 injection in healthy subjects. In addition, this study will provide information on pharmacokinetics and pharmacodynamics of SHR-2004…
- Trial name
- NCT05369767
- Testing
- SAD, SHR-2004
- Where
- China
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Beijing Suncadia Pharmaceuticals Co., Ltd
Type 2 Diabetes Mellitus
Placebo Controlled, Dose Escalation Study in Subjects With Type 2 Diabetes Mellitus Being Treated With Sulfonylurea
The purpose of this study is to provide an initial assessment of the safety, tolerability and efficacy of ISIS 113715 in combination with sulfonylurea in type 2 diabetes subjects.
- Trial name
- NCT00455598
- Testing
- ISIS 113715
- Where
- 39 sites in Poland, Romania and 1 more
- Volunteers
- 88 people
- Sponsor
- Ionis Pharmaceuticals, Inc.
Cytomegalovirus
Safety Study of Four Chimera Cytomegalovirus (CMV) Vaccines in Healthy Adult Males 30-50 Years of Age
The purpose of this research study is to test the safety and tolerability of four new investigational Cytomegalovirus (CMV) vaccines (Towne-Toledo 1, 2, 3, 4) in healthy male volunteers who are CMV negative.
- Trial name
- NCT01195571
- Testing
- cmv vaccine
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- CMV Research Foundation
Neoplasm Malignant, Epithelial Ovarian Cancer
Study of XL102 as Single-Agent and Combination Therapy in Subjects With Solid Tumors (QUARTZ-101)
This is a Phase 1, open-label, dose-escalation and expansion study evaluating the safety, tolerability, PK, antitumor activity, and effect on biomarkers of XL102 administered orally alone and in multiple combination regimens to…
- Conditions
- Neoplasm Malignant, Epithelial Ovarian Cancer, Triple Negative Breast Cancer, Hormone Receptor Positive Breast Carcinoma
- Trial name
- NCT04726332
- Testing
- XL102, Fulvestrant, Abiraterone
- Where
- 5 sites in United States
- Volunteers
- 52 people
- Sponsor
- Exelixis
Advanced Solid Tumor
Study to Access Anti-CD38 Anibody Drug in Patients With Advanced Solid Tumors
This study is a Phase 1b, single-center, open-label, dose-finding trial designed to identify the Recommended Phase 2 Dose (RP2D) of STI 6129 by assessing the safety, preliminary efficacy, and immunogenicity in subjects with any…
- Trial name
- NCT05584709
- Testing
- STI-6129
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Sorrento Therapeutics, Inc.
Healthy
A Study to Learn How Different Amounts of the Study Medicine Called PF-07976016 Are Tolerated and Act in The Body in Healthy Adults
The purpose of this clinical trial is to learn if the study medicine (called PF-07976016) is safe and how it goes in and out of the body in healthy people.
- Trial name
- NCT06106009
- Testing
- PF-07976016, Midazolam
- Where
- United States
- Volunteers
- 117 people, healthy volunteers welcome
- Sponsor
- Pfizer
Advanced Solid Tumor
Study of ZG0895.HCl in Patients With Advanced Solid Tumors
The primary objective of this study is to assess the tolerability and safety of ZG0895.HCl, and to assess the maximum tolerated dose (MTD)/ recommended phase 2 dose (RP2D) of ZG0895.HCl.
- Trial name
- NCT05877664
- Testing
- ZG0895 Hydrochloride for Injection
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Patients With Advanced Solid Tumors
ABOD2011 in Patients With Advanced Solid Tumors Progressed After Standard Systemic Therapy
Based on the activation and regulation of immune system by cytokines, mRNA encoding cytokines has become one of the important directions of mRNA tumor drug development.
- Trial name
- NCT05392699
- Testing
- human single chain IL-12 mRNA-single dose, human single chain IL-12 mRNA-multiple dose
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Shigellosis
A Phase 1, Dose Escalation Study, to Evaluate a New Shigella Sonnei Vaccine in Healthy Adults.
This Phase 1 clinical trial is aimed to evaluate the safety and immunogenicity of 3 doses of 5 sequentially escalating dosages of a candidate vaccine against Shigella sonnei (1790GAHB vaccine) administered by intramuscular route…
- Trial name
- NCT02017899
- Testing
- S. sonnei 1790GAHB
- Where
- France
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- GSK Vaccines Institute For Global Health S.r.l.
Healthy Subjects
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ALXN1007 in Healthy Male and Female Subjects
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple intravenous (IV) doses of ALXN1007 in healthy male and female subjects.
- Trial name
- NCT01883544
- Testing
- ALXN1007
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Healthy Participants
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AK0406 Injection in Healthy Adult Participants
This study is a phase I, single-center, randomized, double-blind, placebo-controlled study of AK0406 as a first-in-human (FIH) trial to evaluate the safety, tolerability and pharmacokinetics (PK) of AK0406 in healthy adult…
- Trial name
- NCT07432698
- Testing
- AK0406 150 mg, AK0406 300 mg, AK0406 600 mg
- Where
- Australia
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Shanghai Ark Biopharmaceutical Co., Ltd.
Cystic Fibrosis
A Study Evaluating Safety and Pharmacokinetics of VX-440 in Combination With Tezacaftor/Ivacaftor in Healthy Adult Subjects
This study evaluated the safety and pharmacokinetics of multiple ascending doses of VX-440 in combination with tezacaftor/ivacaftor (TEZ/IVA) (triple combination [TC]) administered for 13 days to healthy male and female subjects
- Trial name
- NCT03486236
- Testing
- VX-440, TEZ, IVA
- Where
- United Kingdom
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
Schizophrenia
Safety, Tolerability, and Pharmacokinetics of OMS643762 in Psychiatrically Stable Schizophrenia Subjects
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of OMS643762 (the study drug) in psychiatrically stable schizophrenia patients.
- Trial name
- NCT01952132
- Testing
- OMS643762
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Omeros Corporation
Healthy
Safety and Tolerability of 4 Different Dosage Strengths of BIBW 2992 Tablets to Healthy Male Volunteers
Study to assess pharmacokinetics incl. dose proportionality, safety and tolerability of 4 different dosage strengths of BIBW 2992 tablets (final formulation of 20 mg, 30 mg, 40 mg, 50 mg) administered as single doses to healthy…
- Trial name
- NCT02171767
- Testing
- BIBW 2992 MA2 - single rising dose
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Diabetes, Diabetes Mellitus, Type 2
Safety, Tolerability and Pharmacokinetics of Liraglutide-depot in Healthy Subjects
This trial is conducted in the United States of America (USA). The aim of this trial is to investigate the safety, tolerability and pharmacokinetics (exposure in the body) of liraglutide-depot in healthy subjects.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2, Healthy
- Trial name
- NCT01473953
- Testing
- liraglutide-depot
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Novo Nordisk A/S
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