Clinical trials: Phase I
Respiratory Syncytial Virus Immunization
Study of a Respiratory Syncytial Virus Candidate Encapsulated in a Lipid Nanoparticle Based Formulation in Adults Aged 18 to 50 Years and 60 Years and Older
Brief Summary of Stage 1: The purpose of Stage 1 (Phase I/IIa) was to assess the safety and immunogenicity of a single intramuscular (IM) injection of 3 dose-levels of an Respiratory Syncytial Virus (RSV) vaccine candidate…
- Trial name
- NCT05639894
- Testing
- RSV vaccine candidate
- Where
- 33 sites in United States, Australia and 1 more
- Volunteers
- 865 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
TNBC - Triple-Negative Breast Cancer
Targeting Metastatic Breast Cancers by Alkaline Glucosodiene Molecules Via a Metabolic Pathway Phase I Clinical Trial
The diverse group of breast tumors known as triple-negative breast cancer (TNBC) which is lethally and deadly type of breast cancer and insensitive to endocrine therapy and HER2-targeted therapy because it lacks the expression of…
- Trial name
- NCT05957939
- Testing
- Alkaline Glucosodiene Molecules
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Ministry of Health, Saudi Arabia
Alzheimer Disease, Alzheimer Disease (AD)
Phase I Clinical Study of AV-1959R: Abeta-targeting Anti-Alzheimer's Vaccine
This Phase 1 clinical trial evaluates the safety, tolerability, and immune response of the adjuvanted AV-1959R vaccine in healthy adults aged 40-60.
- Conditions
- Alzheimer Disease, Alzheimer Disease (AD), Alzheimers Disease Prevention
- Trial name
- NCT06831812
- Testing
- AV-1959R (Abeta vaccine)
- Where
- Australia
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Nuravax, Inc.
Healthy
A Drug Interaction Study of SPD503 and Vyvanse Administered Alone and In Combination in Normal Healthy Volunteers
Drug-drug interaction study; to examine the pharmacokinetics of SPD503 and VYVANSE (lisdexamfetamine dimesylate) when given alone, and in combination.
- Trial name
- NCT00919867
- Testing
- SPD503, VYVANSE, SPD503 and VYVANSE
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Shire
Healthy
Study to Assess the Effect of Food on a Single Dose of Acoramidis in Healthy Adult Participants
The purpose of this study is to determine the effect of a high-fat, high-caloric meal on the pharmacokinetics (PK) of acoramidis in healthy adult participants following an oral single dose administration of acoramidis.
- Trial name
- NCT04958135
- Testing
- Acoramidis
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Healthy
IV Dosage Form of LCB01-0371 Phase I Study in Healthy Male Volunteers
Primary - To investigate the Pharmacokinetics, Safety, and Tolerability of Intravenous dosage form of LCB01-0371 comparing to oral dosage in Healthy Male Volunteers Secondary To investigate the absolute bio availability of…
- Trial name
- NCT02882789
- Testing
- LCB01-0371, LCB01-0371 400mg
- Where
- South Korea
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- LigaChem Biosciences, Inc.
Chronic Weight Management
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of ASC30 Injection in Participants With Obesity
This randomized, double-blind, placebo-controlled single ascending dose (SAD)/ multiple ascending dose (MAD) study is designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of ASC30 injection
- Trial name
- NCT06679959
- Where
- United States
- Volunteers
- 115 people, healthy volunteers welcome
- Sponsor
- Ascletis Pharma (China) Co., Limited
Influenza, Human
Seasonal Trivalent Inactivated Split Virion Influenza Vaccine Clinical Trial (IVACFLU-S)
This is a phase I, double-blind, randomized, placebo-controlled trial with two groups of subjects to receive seasonal trivalent inactivated split virion influenza vaccine (A/H1N1; A/H3N2 and B strains) or placebo (phosphate…
- Trial name
- IVACFLU-S (NCT02598089)
- Testing
- Trivalent Seasonal Influenza Vaccine
- Where
- Vietnam
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Institute of Vaccines and Medical Biologicals, Vietnam
Healthy Women, Female Contraception
A Study to Evaluate the PK and PD of IM or SQ Injections of Levonorgestrel Butanoate (LB) for Female Contraception
This is a Phase I multicenter, open-label, dose-ranging, three-dose PK and PD study of injectable LB administered as an IM or SQ injection at 40 mg, and subsequently at 50mg SQ and then 60 mg SQ depending on the preliminary…
- Trial name
- NCT04143659
- Testing
- levonorgestrel butanoate (LB) injection
- Where
- 7 sites in United States
- Volunteers
- 136 people, healthy volunteers welcome
- Sponsor
- Premier Research
Health Participants
A Study to Assess Safety, Tolerability and Pharmacokinetics of Transdermal SFG-02 in Healthy Participants
This Phase 1 study will evaluate the safety, tolerability, and pharmacokinetics of a novel transdermal formulation of SFG-02 following single and repeated applications in Japanese and White healthy adult participants.
- Trial name
- NCT07167914
- Testing
- SFG-02
- Where
- Japan
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Juro Sciences Inc.
Healthy
Study of Radiolabeled Danicopan in Healthy Male Participants
This was an open-label study to evaluate the absorption, distribution, metabolism, and excretion of radioactivity in healthy male participants following a single 150-milligram (mg) oral dose of carbon-14 ([14C])-ACH-014447…
- Trial name
- NCT04889391
- Testing
- [14C]-Danicopan
- Where
- New Zealand
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Hypertrophic Cardiomyopathy
A Trial of HRS-1893 in Healthy Volunteers
The purpose of this study is to assess the safety and PK characteristics of a single oral dose of HRS-1893 in healthy voluunters.
- Trial name
- NCT07033455
- Testing
- HRS-1893
- Where
- Australia
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Atridia Pty Ltd.
Pneumococcal Infection
A Phase I Study to Evaluate the Safety and Immunogenicity of PnuBioVax
Streptococcus pneumoniae is a type of bacteria that can cause infections of the ears, sinuses or lungs. It can also cause more serious infections of the blood or brain.
- Trial name
- NCT02572635
- Testing
- PnuBioVax
- Where
- United Kingdom
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- ImmunoBiology Limited
HIV Infections
Evaluating the Safety and Immune Response to Two HIV Vaccine Regimens in Healthy, HIV-Uninfected Adults in the United States and South Africa
The purpose of this study is to evaluate the safety and immune response to two different HIV vaccine regimens in healthy, HIV-uninfected people in the United States and South Africa.
- Trial name
- NCT01927835
- Testing
- DNA-HIV-PT123 vaccine, NYVAC-HIV-PT1 vaccine, NYVAC-HIV-PT4 vaccine
- Volunteers
- healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Safety, Pharmacokinetics, Pharmacodynamics, Food Effect
Single + Multiple Ascending Dose and Food Effect Study of AZD7986 in Healthy Volunteers, PK, PD and Safety Study
This is a phase I, randomised, single-blind placebo-controlled, 2-part study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of single and multiple oral doses of AZD7986 in healthy volunteers
- Trial name
- NCT02303574
- Testing
- AZD7986, oral solution, 1 to 50 mg/mL
- Where
- United Kingdom
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
A Study of the Hedgehog Pathway Inhibitor GDC-0449 in Healthy Female Subjects of Non-Childbearing Potential
This is an open-label, Phase I, single-center, single-dose administration study to determine the absolute bioavailability, clearance, and volume of distribution of GDC-0449 (Part A) and to determine the routes of excretion and…
- Trial name
- NCT00991718
- Testing
- GDC-0449 oral capsules (non-labeled), GDC-0449 IV injection (labeled), CDC-0449 oral suspension (labeled)
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Genentech, Inc.
Healthy Volunteers
Phase 1 Study to Determine the Effects of Food on the Pharmacokinetic Profile of PBT2
This study is designed to determine the pharmacokinetic (PK) profile of a single oral dose of PBT2 administered to healthy volunteers in the presence and absence of food.
- Trial name
- NCT02107313
- Testing
- Fed Cohort PBT2, Fasted Cohort PBT2
- Where
- Australia
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Prana Biotechnology Limited
Hepatic Impairment
A Phase I Study to Investigate the Effect of Hepatic Impairment of AZD9550 and AZD6234
The purpose of this study is to examine the safety and tolerability of AZD6234 and AZD9550 in participants with hepatic impairment and participants with normal hepatic function.
- Trial name
- NCT07546760
- Testing
- AZD6234, AZD9550
- Where
- 4 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
A Safety, Tolerability, Pharmacokinetics, and Immunogenicity Study of CNTO 6785 in Healthy Volunteers
The purpose of this study is to evaluate the safety, tolerability, blood levels, and immune responses of CNTO 6785 after administration to healthy adult volunteers.
- Trial name
- NCT01288196
- Testing
- CNTO 6785 1 mg/kg IV, CNTO 6785 3 mg/kg IV, CNTO 6785 10 mg/kg IV
- Where
- Belgium
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Janssen-Cilag International NV
Healthy Female Volunteers
A Study to Evaluate the Drug-drug Interaction of BMS-986196 With Oral Contraceptives in Healthy Female Participants
The purpose of this study is to evaluate the effect of BMS-986196 when coadministered with combined hormonal oral contraceptives (ethinyl estradiol [EE] and norethindrone [NET]) in healthy female participants.
- Trial name
- NCT05891262
- Testing
- BMS-986196, Loestrin
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
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