Clinical trials: Phase 1
Healthy
A Safety and Pharmacokinetic Study Between HLX02 and Herceptin®(US-licensed and EU-approved) in Healthy Chinese Male Subjects
Randomised, double-blind, parallel group Phase I study to compare PK profiles and to assess the safety and immunogenicity between HLX02 and Herceptin® (U.S. and EU).
- Trial name
- NCT04670796
- Testing
- HLX02, EU-sourced Trastuzumab (Herceptin®), US-licensed Trastuzumab (Herceptin®)
- Where
- China
- Volunteers
- 111 people, healthy volunteers welcome
- Sponsor
- Shanghai Henlius Biotech
Covid19, SARS-CoV Infection
Reactogenicity, Safety and Immunogenicity of QazCoVac-P COVID-19 Vaccine
Randomized, Blind, Placebo-controlled Phase- I Study and Randomized, Open Phase Phase-II Study of QazCoVac-P - COVID-19 Subunit Vaccine in Healthy Adult Volunteers From 18 Years Old and Elder
- Conditions
- Covid19, SARS-CoV Infection, Vaccine Adverse Reaction
- Trial name
- NCT04930003
- Testing
- QazCoVac-P -COVID-19 Subunit Vaccine
- Where
- Kazakhstan
- Volunteers
- 244 people, healthy volunteers welcome
- Sponsor
- Research Institute for Biological Safety Problems
ALS
Study of [11C]CPPC as a Clinical PET Radioligand Biomarker of Microglial Activation in ALS
1. Establish the safety and tolerability of the 5-cyano-N-(4-(4-[11C]Methylpiperazin-1-yl)-2-(Piperidin-1-yl)Phenyl)Furan-2-carboxamide ([11C]CPPC) PET radioligand in ALS patients and controls 2.
- Trial name
- NCT05602142
- Testing
- [11C]CPPC PET ligand
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Ebola Virus
Ebola Sudan Chimpanzee Adenovirus Vector Vaccine in Healthy Adults
RV 508 was a Phase I, open-label, dose-escalation study to examine the safety, tolerability and immunogenicity of an investigational Ebola vaccine in healthy adults.
- Trial name
- NCT04041570
- Testing
- cAd3-EBO S vaccine
- Where
- Uganda
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Mass Balance Study
Study on Mass Balance of [14C]HMPL-306（Isocitrate Dehydrogenase Inhibitor） in Healthy Chinese Adult Male Subjects
To evaluate the absorption, metabolism and excretion in healthy Chinese male subjects after a single oral dose of [14C]HMPL-306
- Trial name
- NCT06671873
- Testing
- 100 µCi [14C] HMPL-306
- Where
- China
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Hutchmed
Healthy Volunteer
Phase 1 Study to Evaluate ASN002 Absorption, Metabolism, and Excretion of [14C] Following a Single Oral Dose in Healthy Male Subjects
Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C] ASN002 Following a Single Oral Dose in Healthy Male Subjects
- Trial name
- NCT03641573
- Testing
- [14C] ASN002
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Asana BioSciences
Healthy, West Nile Fever
Vaccine to Prevent West Nile Virus Disease
This study will test the safety of an experimental vaccine intended to prevent West Nile virus (WNV) infection and determine if it causes side effects.
- Conditions
- Healthy, West Nile Fever, Healthy Volunteer, HV
- Trial name
- NCT00106769
- Testing
- VRC-WNVDNA017-00-VP
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Monkeypox
A Clinical Study Investigating the Safety and Immune Responses After Immunization With Investigational Monkeypox Vaccines
This was a dose-escalation, Phase I/II study evaluating the safety, tolerability, reactogenicity and immunogenicity of the investigational RNA-based multivalent vaccine candidate BNT166a for active immunization against monkeypox…
- Trial name
- NCT05988203
- Testing
- BNT166a
- Where
- 9 sites in United States, United Kingdom
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- BioNTech SE
Atherosclerosis, Subclinical Atherosclerosis
DETECTion of the Prevalence of Silent Atherosclerosis Across Adult Life - Phase I of REACT
Atherosclerosis is preventable, yet it continues to significantly contribute to global morbidity and mortality. Atherosclerosis may occur early in life and may present in all vascular territories.
- Conditions
- Atherosclerosis, Subclinical Atherosclerosis, Cardiovascular Diseases
- Trial name
- DETECT (NCT06692127)
- Where
- 5 sites in Denmark, Spain
- Volunteers
- 16,808 people, healthy volunteers welcome
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Healthy Volunteers, OTC Deficiency
Study of CMP-CPS-001 in Healthy Volunteers and Participants With Abnormal Heterozygous OTC Genotype
The objective of this clinical study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of CMP-CPS-001 administered as a subcutaneous injection in adult healthy…
- Trial name
- NCT06247670
- Testing
- CMP-CPS-001
- Where
- 2 sites in Australia, Netherlands
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- CAMP4 Therapeutics Corporation
Cystic Fibrosis
A Study to Assess the Safety, Tolerability and PK Profile of FDL176 in Healthy and CF Participants
This is a 5-part study of FDL176. Part 1 is a double blind, placebo-controlled, dose escalation study in healthy male participants. Part 2 is a single dose, open-label study in healthy male participants.
- Trial name
- NCT03173573
- Testing
- FDL176
- Where
- 3 sites in Australia
- Volunteers
- 109 people, healthy volunteers welcome
- Sponsor
- Flatley Discovery Lab LLC
Erectile Dysfunction
Study to Compare the Effects of Viagra® Vs Hezkue® in Healthy Fasted Male Participants.
The objective of this phase 1, open-label, single-center, two-way crossover trial is to evaluate the pharmacokinetics (PK), safety, and tolerability of 100 mg ASP-001 oral liquid suspension versus 100 mg Viagra (sildenafil…
- Trial name
- NCT06782659
- Testing
- ASP-001, Viagra
- Where
- 2 sites in United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Aspargo Labs, Inc
Healthy Volunteers
A Phase I Open-Label Study of the Effects of Tacrolimus and Cyclosporine on CP-690,555 in Healthy Volunteers
A new immunosuppressive drug, based on the inhibition of important enzymes in the immune system, called JAK, is being developed by Pfizer to prevent transplant rejection.
- Trial name
- NCT00860496
- Testing
- CP- 690,550 and Tacrolimus, CP- 690,550 and Cyclosporine
- Where
- Singapore
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
Study of VGX-3400X, H5N1 Avian Influenza Virus DNA Plasmid + Electroporation in Healthy Adults
DNA vaccines consist of small pieces of DNA also known as plasmids, and have several potential advantages over traditional vaccines. Thus far, DNA vaccines appear to be well tolerated in humans.
- Trial name
- NCT01142362
- Testing
- VGX-3400X
- Where
- 2 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Inovio Pharmaceuticals
Healthy
Study In Healthy Subjects To Evaluate The Changes In The Protein sAPP-Alpha In Cerebrospinal Fluid Following A Single Oral Dose Of PF-04995274
The primary purpose of the study is to evaluate the effect of PF-04995274 on cerebrospinal fluid levels of soluble Amyloid precursor protein fragments and Amyloid beta fragments following single oral dose in healthy volunteers.
- Trial name
- NCT01193062
- Testing
- PF-04995274
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Pfizer
Malaria
Safety and Pharmacokinetics Study of DM1157 to Treat Malaria
This is a phase 1 trial to evaluate the safety and pharmacokinetics of single and multiple ascending doses and effect of food on the pharmacokinetics of a novel antimalarial drug in healthy adults.
- Trial name
- NCT03490162
- Testing
- DM1157
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Healthy Subjects
A Phase I Study of the Interaction of D-2570 With Other Drugs in Healthy Adults
The primary purpose of this study is to characterize the drug-drug interaction profiles of D-2570 with midazolam, digoxin, rosuvastatin, metformin, itraconazole, rifampicin, and omeprazole.
- Trial name
- NCT07875842
- Testing
- Itraconazole, Rifampicin, Omeprazole
- Where
- China
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- InventisBio Co., Ltd
Vulvovaginal Atrophy, Vasomotor Symptoms
Study of DARE-HRT1 Over 12 Weeks in Healthy PostMenopausal Women
Randomized, Open-label 2-arm, parallel group study in approximately 20 healthy postmenopausal women to assess the safety of DARE-HRT1 Intravaginal Rings in two different dose strengths and the PK of progesterone and estradiol…
- Trial name
- DARE-HRT1 (NCT05367973)
- Testing
- IVR Dose 1, IVR Dose 2
- Where
- 2 sites in Australia
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Daré Bioscience, Inc.
Healthy
Pharmacokinetic Interaction Between SSP-004184 (SPD602) and Midazolam in Healthy Adult Subjects
A Study to Evaluate the Pharmacokinetic Interaction Between SSP-004184 and Midazolam in Healthy Adult Subjects
- Trial name
- NCT01989169
- Testing
- Midazolam, SSP-004184SS
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Shire
Premature Ejaculation
A Safety and Tolerability of PSD502 (a Topical Anesthetic) in the Treatment of Premature Ejaculation
A phase I, single-center, double-blind, randomized, placebo-controlled, safety and pharmacokinetic study to evaluate systemic and local vaginal exposure to lidocaine and prilocaine and the metabolites, 2,6-dimethylaniline…
- Trial name
- NCT01184105
- Testing
- Intervention A, Intervention B
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Plethora Solutions Ltd
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