Clinical trials: Phase I
Cancer, mCRC
Phase I PK Comparison of HLX05 vs. Erbitux® in Healthy Chinese Males: Safety, Immunogenicity, and Pharmacokinetics
This is a randomized, single intravenous dose, parallel study to compare the PK characteristics, safety, tolerability, and immunogenicity of HLX05 vs. Erbitux® (US-, EU-, and CN-sourced) in healthy adult male Chinese subjects.
- Trial name
- NCT06980454
- Testing
- HLX05, EU-Erbitux®, US-Erbitux®
- Where
- 2 sites in China
- Volunteers
- 322 people, healthy volunteers welcome
- Sponsor
- Shanghai Henlius Biotech
Parkinson Disease
A Phase I Study of TRN501 in Healthy Volunteers
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of TRN501 following a single administration of TRN501 or placebo to healthy adult male volunteers.
- Trial name
- NCT06453551
- Testing
- TRN501 - Dose 1, TRN501 - Dose 2, TRN501 - Dose 3
- Where
- Japan
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- SNLD, Ltd.
Asthma, COPD
An Evaluation of 9MW1911 Injection in Healthy Subjects
This study is a randomized, double-blind, dose-escalating phase I clinical study to evaluate the safety, tolerability and pharmacokinetics of 9MW1911 injection in healthy subjects.
- Conditions
- Asthma, COPD, Atopic Dermatitis
- Trial name
- NCT05803902
- Testing
- Experimental drug 9MW1911
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
Pharmacokinetics of Isavuconazole, Pharmacokinetics of Bupropion
Drug Interaction Study of Multiple Doses of Isavuconazole and a Single Dose of Bupropion
The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of a single dose of bupropion.
- Conditions
- Pharmacokinetics of Isavuconazole, Pharmacokinetics of Bupropion, Healthy Volunteers
- Trial name
- NCT01635972
- Testing
- Isavuconazole, bupropion hydrochloride
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Healthy
A Multiple Ascending Dose Study to Investigate Safety of KBP-7072 in Healthy Subjects
This is a double-blind, placebo-controlled, multiple oral dose study to evaluate safety, tolerability, and pharmacokinetic of KBP-7072 in healthy subjects.
- Trial name
- NCT04532957
- Testing
- KBP-7072
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- KBP Biosciences
Normal Renal Function, Impaired Renal Function
Evaluation of Renal Function Impairment on the Pharmacokinetics of LEE011
The purpose of this study is to characterize the PK and safety profile of LEE011 following a single oral dose in adult subjects with various degrees of renal impairment compared to a matched group of healthy subjects with normal…
- Trial name
- NCT02431481
- Testing
- LEE011
- Where
- 4 sites in United States, Bulgaria and 2 more
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Schizophrenia
A Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetic Characteristics of KR23248 Capsules in Healthy Adult Subjects
This study aims to investigate the safety, tolerability and pharmacokinetic characteristics of KR23248 capsules in healthy subjects. This study will be conducted in China.
- Trial name
- NCT07585383
- Testing
- KR23248
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Jiangxi Kvvit Pharmaceutical Co., Ltd.
Brain Neoplasms, Glioma
A Pediatric Phase I Trial of RMP-7 and Carboplatin in Brain Tumors
The presence of a highly selective blood-brain barrier (BBB) at the level of the brain capillary endothelium prevents chemotherapeutic agents from attaining therapeutic concentrations at the target site.
- Conditions
- Brain Neoplasms, Glioma, Medulloblastoma
- Trial name
- NCT00001502
- Testing
- RMP-7 and carboplatin
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- National Cancer Institute (NCI)
Healthy Volunteers
A Study to Investigate the Absorption, Metabolism and Excretion of [14C]-BGB-11417
The main objective of this study is to determine the mass balance, routes of elimination, and pharmacokinetics of [14C]-BGB-11417 in healthy male participants along with determining the concentrations of radioactivity in plasma…
- Trial name
- NCT05844111
- Testing
- [14C]-BGB-11417
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- BeiGene
Plasmodium Falciparum Malaria
Phase 1 Trial of a Malaria Vaccine in Young Kenyan Children
To assess the safety and reactogenicity of the FMP-1/AS02A malaria vaccine in malaria-exposed children living in western Kenya and aged 12-47 months
- Trial name
- NCT00317473
- Testing
- FMP1/AS02A Malaria vaccine, Imovax Rabies vaccine
- Where
- Kenya
- Volunteers
- 135 people, healthy volunteers welcome
- Sponsor
- U.S. Army Medical Research and Development Command
Diabetes
A Study of CT-388 in Otherwise Healthy Overweight and Obese Adults and Patients With Type 2 Diabetes Mellitus
This is a first-in-human evaluation of CT-388 in a double blind, placebo controlled, randomized, SAD/MAD/MD, safety, tolerance, PK, and PD study when administered as a SC injection in otherwise healthy overweight and obese adult…
- Trial name
- NCT04838405
- Testing
- CT-388
- Where
- 2 sites in Australia, Mexico
- Volunteers
- 129 people, healthy volunteers welcome
- Sponsor
- Carmot Therapeutics, Inc.
Zika Virus
Evaluation of Two Zika Viruses for Use in Controlled Human Infection Models (CHIM)
This study will include 4 cohorts of 14 ZIKV and DENV-naïve female and male subjects, 18 - 40 years of age (total: up to 56 subjects).
- Trial name
- NCT05123222
- Testing
- ZIKV-SJRP/2016-184 Strain, Experimental: ZIKV-Nicaragua/2016 Strain
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Infectious Disease, COVID-19
Safety and Immunogenicity of RVM-V001 in Healthy Individuals Previously Vaccinated With BNT162b2 and mRNA-1273
Phase 1, open-label, dose-escalation study to evaluate the safety, tolerability, and immunogenicity of RVM-V001 administered as a single intramuscular injection in healthy adults.
- Trial name
- NCT05420077
- Testing
- RVM-V001 10 µg, RVM-V001 30 µg, RVM-V001 60 µg
- Where
- 2 sites in Australia
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- RVAC Medicines (US), Inc.
Herpes Zoster
A Study to Describe the Safety, Reactogenicity, and Immunogenicity of Herpes Zoster IN001 mRNA Vaccine (IN001) in Healthy Participants
The study will evaluate the safety, tolerability, and immunogenicity (your immune system's reaction) of the study vaccine called Herpes Zoster IN001 mRNA Vaccine (IN001) in healthy participants who are between 50 and 69 years of…
- Trial name
- NCT06375512
- Testing
- HZ Vaccine (IN001), Shingrix
- Where
- 3 sites in United States, Australia
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Shenzhen Shenxin Biotechnology Co., Ltd
Overweight or Obesity
A Study to Evaluate MWN109 Tablets in Healthy Adult Participants
This is a Phase 1, randomized, double-blind, placebo-controlled, single-and-multiple ascending dose study in which the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of orally administered…
- Trial name
- NCT06938269
- Testing
- MWN109 tablet
- Where
- 2 sites in Australia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Shanghai Minwei Biotechnology Co., Ltd
Myelofibrosis
Study to Evaluate the Effect of Rabeprazole Sodium Enteric-coated Tablets on the Pharmacokinetics of TQ05105 Tablets
Primary objective: To evaluate the effect of rabeprazole on the primary pharmacokinetics of TQ05105 tablets. Secondary objective: To assess the safety and tolerability of single oral administration of TQ05105 tablets alone and in…
- Trial name
- NCT07608666
- Testing
- TQ05105 tablets, Rabeprazole sodium enteric-coated tablets
- Where
- China
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Healthy
Clinical Trial of Comparing DA-5222 Single-administration and Co-administration of DA-5222-R1, DA-5222-R2 and DA-5222-R3 in Healthy Adult Subjects
This study is to compare pharmacokinetics and safety profiles of DA-5222 single-administration and co-administration of DA-5222-R1, DA-5222-R2 and DA-5222-R3 in healthy adult subjects
- Trial name
- NCT06993181
- Testing
- DA-5222, DA-5222-R1, DA-5222-R2
- Where
- South Korea
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Dong-A ST Co., Ltd.
Healthy
A Drug-Drug Interaction Study of Carbamazepine and Opevesostat (MK-5684) in Healthy Adult Male Participants (MK-5684-012)
Researchers have designed a study medicine called opevesostat as a new way to treat prostate cancer. The purpose of this study is to learn what happens to opevesostat in a person's body over time (a pharmacokinetic or PK study).
- Trial name
- NCT06633419
- Testing
- Opevesostat, Prednisone, Fludrocortisone acetate
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Healthy Participants
A Single and Multiple Ascending Dose Study of BMS-986318 in Healthy Participants
A study to evaluate single and multiple ascending doses of experimental medicine BMS-986318 in healthy participants.
- Trial name
- NCT04082741
- Testing
- BMS-986318
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Respiratory Syncytial Virus Infections
A Study to Assess Safety, Tolerability and Immunogenicity of the Live Attenuated hRSV Vaccine rBCG-N-hRSV
Human respiratory syncytial virus (hRSV) is the main cause of lower respiratory tract infection in children under one year of age.
- Trial name
- EVA-VRS01 (NCT03213405)
- Testing
- rBCG-N-hRSV 1/100, rBCG-N-hRSV 1/10, rBCG-N-hRSV full dose
- Where
- Chile
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pontificia Universidad Catolica de Chile
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