Clinical trials: Phase I
Alopecia Areata
A Study to Evaluate the Safety of MAX-40070 in Healthy Subjects
This is a First-in-Human phase I study to evaluate the safety, tolerability and pharmacokinetic characteristics of MAX-40070 in Healthy SubjectThe study will be comprised of 2 parts; Part A and Part B.
- Trial name
- NCT05196711
- Testing
- MAX-40070
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Maxinovel Pty., Ltd.
Bacterial Sepsis
Detoxified J5 Core Glycolipid/ Group B Meningococcal Outer Membrane Protein Vaccine for Gram-negative Bacterial Sepsis Administered With and Without Synthetic CPG Oligodeoxynucleotide 7909 Adjuvant
The purpose of this study is to test the safety of an experimental vaccine against sepsis (infection of the blood) alone and with an experimental adjuvant (a substance that may improve vaccine effectiveness).
- Trial name
- NCT01164514
- Testing
- CPG 7909, J5-OMP Vaccine
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Healthy Subjects
A Clinical Study of AK139 in Healthy Subjects
This is a phase I clinical study on dose escalation evaluating the safety, tolerability, PK and PD of a single dose of AK139 administered subcutaneously in healthy subjects.
- Trial name
- NCT06947109
- Testing
- AK111
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Akeso
Infection, Human Immunodeficiency Virus
Dolutegravir Renal Impairment Study
Dolutegravir (DTG, GSK1349572) is an integrase inhibitor being developed for the treatment of human immunodeficiency virus (HIV)-1 infection by GlaxoSmithKline (GSK) on behalf of Shionogi-ViiV Healthcare LLC.
- Trial name
- NCT01353716
- Testing
- Dolutegravir 50 mg
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Healthy Volunteers
Single and Multiple Ascending Dosing Administration of MF-300 in Healthy Participants
The study will consist of 2 parts, Study Parts 1 (1a: single ascending dose [SAD] Phase; and 1b: Food Effect Phase) and Part 2 (multiple ascending dose [MAD] Phase).
- Trial name
- NCT07613684
- Testing
- MF-300 SAD, MF-300 Food Effect, MF-300 MAD
- Where
- 2 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Epirium Bio Inc.
Pharmacokinetics
Phase-I Study Evaluating the Pharmacokinetic Profile of RhuDex®
The drug that is under investigation during this study is RhuDex® and is expected to be used as an oral treatment for rheumatoid arthritis.
- Trial name
- NCT00532012
- Testing
- RhuDex®
- Where
- United Kingdom
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- MediGene
Healthy
A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of DC-853 in Healthy Participants
The main purpose of this study is to assess the safety and tolerability of LY4100511 (DC-853) after single and multiple dose administrations in healthy participants. Participation could last up to 7 weeks
- Trial name
- NCT06937411
- Testing
- LY4100511
- Where
- United Kingdom
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
HSV-2
A Safety Study to Assess a DNA Vaccine Administered by Particle Mediated Delivery to the Skin in Healthy Subjects
The purpose of this study is to evaluate how well the vaccine is tolerated at sites where administrations are given and any effects it may have on subjects' wellbeing.
- Trial name
- NCT00310271
- Testing
- pPJV7630 with pPJV2012 administered by PMED
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- PowderMed
Healthy Volunteers
A Phase 1 Study of SMP-100 in Normal Healthy Volunteers
This will be the first clinical study of oral administration SMP-100 in healthy subjects. The proposed randomized Phase 1 trial is a double-blind, placebo-controlled, single and multiple ascending dose study in approximately 72…
- Trial name
- NCT04296799
- Testing
- SMP-100
- Where
- Australia
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Chengdu SciMount Pharmatech Co., Ltd.
Human Volunteers
A Study To Estimate The Effect Of Ketoconazole On The Pharmacokinetics Of Pf-04937319 In Healthy Subjects
This study will evaluate the potential for a drug-drug interaction of PF-04937319 with ketoconazole, a potent inhibitor of the drug metabolizing enzyme CYP3A.
- Trial name
- NCT01468714
- Testing
- PF-04937319 / ketoconazole
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Pfizer
GERD
Investigate Linaprazan Glurate/Linaprazan in Healthy Subjects
This is a Phase I, single-center, open label parallel-group, randomized study designed to evaluate the pharmacokinetics (PK), pharmacodynamics (PD, by continuous intragastric pH measurment), safety and tolerability of single and…
- Trial name
- NCT05742984
- Testing
- linaprazan glurate 25 mg QD, linaprazan glurate 50 mg QD, linaprazan glurate 75 mg QD
- Where
- Slovenia
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Cinclus Pharma Holding AB
Breast Cancer
Exploratory, Phase I,Open Label,Non-randomized Study of [F18]CP-18 PET in Normal and Breast Cancer Subjects
This trial will be the first trial for the IP, [F-18]CP-18, and will be conducted as an exploratory Phase I trial designed to collect information as this IP is administered and evaluated for the first time in humans.
- Trial name
- NCT01362712
- Testing
- [F18]CP-18 Injection
- Where
- 3 sites in United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Siemens Molecular Imaging
Infections, Human Immunodeficiency Virus and Herpesviridae
GSK1349572 Drug Interaction Study With Fosamprenavir/Ritonavir
GSK1349572 is an integrase inhibitor being developed for the treatment of human immunodeficiency virus (HIV)-1 infection by GlaxoSmithKline (GSK) on behalf of Shionogi-ViiV HealthcareLLC.
- Trial name
- NCT01209065
- Testing
- GSK1349572, Fosamprenavir, Ritonavir
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Peritoneal Carcinomatosis, Peritoneal Metastases
CAR-T Intraperitoneal Infusions for CEA-Expressing Adenocarcinoma Peritoneal Metastases or Malignant Ascites (IPC)
This is an open-label, dose-escalation, phase I trial of the safety and efficacy of anti-CEA intraperitoneal CAR-T infusions for treatment in patients with CEA-expressing adenocarcinoma peritoneal metastases or malignant ascites.
- Conditions
- Peritoneal Carcinomatosis, Peritoneal Metastases, Colorectal Cancer, Gastric Cancer
- Trial name
- NCT03682744
- Testing
- anti-CEA CAR-T cells
- Where
- 2 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Sorrento Therapeutics, Inc.
Health Adult Subjects
Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX29 Compared With HLX11
This is a randomized, double-blind, parallel-controlled study to compare the PK profile of HLX29 and HLX11 and evaluate their safety, tolerability, and immunogenicity after a single intravenous dose in healthy male adult…
- Trial name
- NCT07776132
- Testing
- HLX29, HLX11
- Where
- Australia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Shanghai Henlius Biotech
Hepatic Impairment
A Study to Investigate the Pharmacokinetics and Safety of Remibrutinib in Participants With Hepatic Impairment Compared With Matched Healthy Participants
This was a Phase 1, open-label study to evaluate the PK, safety, and tolerability after administration of multiple doses of remibrutinib in participants with mild, moderate, or severe hepatic impairment (HI) compared to pooled…
- Trial name
- NCT05753592
- Testing
- Part 1; LOU064 (Remibrutinib), Part 2; LOU064 (Remibrutinib)
- Where
- Hungary
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Cytomegalovirus
A Study of mRNA-1647 Cytomegalovirus Vaccine in Healthy Participants 9 to 15 Years of Age and Participants 16 to 25 Years of Age
The main purpose of study is to evaluate the safety and immunogenicity of different dose levels of mRNA-1647 versus control in healthy cytomegalovirus (CMV)-seronegative and CMV-seropositive female and male participants 9 to 15…
- Trial name
- NCT05575492
- Testing
- mRNA-1647
- Where
- 57 sites in United States, Canada and 1 more
- Volunteers
- 873 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Pharmacokinetics, Pharmacodynamics
Study to Evaluate Pharmacokinetic and Pharmacodynamic Drug Interactions and Safety of IY-NS250 and IY-NT-SR
This study comparative evaluation of safety and pharmacokinetic and pharmacodynamic properties in oral repeat administration of IY-NS250 and IY-NT-SR in healthy adult
- Trial name
- NCT06725992
- Testing
- IY-NS250, IY-NT-SR
- Where
- South Korea
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Il-Yang Pharm. Co., Ltd.
Acute Bacterial Infections, Acute Viral Infections
300 Antibody Diagnostic Test Kit
For the development of a Point of Care IVD test kit for acute phase disease detection against a variety of bacterial and viral infections.
- Trial name
- Antibody 300 (NCT01646411)
- Where
- United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- The Plasma Source
Pharmacokinetics, Pharmacodynamics
A Phase I Study in Young Healthy Women to Investigate the Effects of Laquinimod on Standard Oral Contraceptive When Both Treatments Are Given Together
This is a single center, randomized, double blind, placebo controlled, 2-way crossover drug-drug interaction (DDI) study to assess the effect of laquinimod on the PK and PD of ethinylestradiol (EE) and levonorgestrel (LNG) a…
- Trial name
- NCT02085863
- Testing
- laquinimod
- Where
- Germany
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
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