Clinical trials: Single Dose
Onchocerciasis
A Pharmacokinetic and Safety Study of Moxidectin to Identify an Optimal Dose for Treatment of Children 4 to 11 Years
The primary purpose of this study is to determine a dose of moxidectin for children 4 to 11 years that is equivalent to an 8 mg dose administered for treatment of onchocerciasis in people 12 years and over.
- Trial name
- NCT03962062
- Testing
- Moxidectin
- Where
- Ghana
- Volunteers
- 36 people
- Sponsor
- Medicines Development for Global Health
Healthy
A Study to Evaluate Oral Formulations of Tedizolid Phosphate in Healthy Participants (MK-1986-043)
The goal of the study is to learn what happens to different oral formulations of tedizolid phosphate (MK-1986) in a healthy person's body over time.
- Trial name
- NCT06733688
- Testing
- Tedizolid Phosphate Oral Formulation 1 (Reference), Tedizolid Phosphate Oral Formulation 2 (Test)
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Herpes Simplex Virus Type I Stromal Keratitis
A Phase Ⅱa Study of the Safety, Tolerability and Efficacy of BD111 in Herpes Simplex Virus Type I Stromal Keratitis
This study aims to compare the clinical efficacy and safety of BD111 injection in combination with standard therapy vs. standard therapy in herpes simplex virus type I stromal keratitis (HSK), providing preliminary confirmation…
- Trial name
- NCT06474442
- Testing
- BD111 Injection (investigational new drug), Triple-drugs therapy of HSV-1 stromal keratitis
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Shanghai BDgene Co., Ltd.
Healthy
To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicel 250 mg/5 ml Oral Suspension Fed Conditions
To demonstrate the relative bioequivalence of Cefdinir and Omnicel 250 mg/5 ml fed conditions.
- Trial name
- NCT00883883
- Testing
- Cefdinir 250 mg/5 ml Suspension (Sandoz, Austria), Omnicef Cefdinir 250 mg/5 ml Suspension (Abbott Laboratories, USA)
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Sandoz
Healthy
Assess the Safety, Tolerability, and Pharmacokinetic (PK) Characteristics of HM10460A (HNK460) in Healthy Adult Korean Subjects
Study Design Randomized, Double-blind, Placebo-controlled, escalating single-dose design. Five ascending dose cohorts. In each cohort, subjects will be randomized to receive a single dose of HM10460A or placebo (negative control)…
- Trial name
- NCT00998283
- Testing
- HM10460A 5μg/kg, HM10460A 15μg/kg, HM10460A 45μg/kg
- Where
- South Korea
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Hanmi Pharmaceutical Company Limited
Multiple Myeloma
A Trial Comparing Single Agent Melphalan to Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) as a Preparative Regimen for Patients With Multiple Myeloma Undergoing High Dose Therapy Followed by Autologous Stem Cell Reinfusion
The work proposed herein aims to provide the first prospective, randomized comparative efficacy data between Melphalan and BEAM treatment regimen in the Multiple Myeloma (MM) patient population.
- Trial name
- BEAM (NCT03570983)
- Testing
- Allopurinol, Carmustine, Etoposide
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Swedish Medical Center
Healthy Volunteers
A Open-label, Single-dose, 2-Sequence, 2-Period, Crossover Study to Assess Safety and Pharmacokinetics of a Nateglinide/Metformin HCl Combined Tablet Compared With a Nateglinide 120 mg Tablet and Metformin HCl 500 mg Tablet Under Fasting Conditions in Healthy Male Subjects
A Randomized, Open-label, Single-dose, 2-Sequence, 2-Period, Crossover Study to Assess Safety and Pharmacokinetics of a Nateglinide/Metformin HCl Combined Tablet Compared with a Nateglinide 120 mg Tablet and Metformin HCl 500 mg…
- Trial name
- NCT02088918
- Testing
- Nateglinide, Nateglinide/Metformin, Metformin
- Where
- South Korea
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- IlDong Pharmaceutical Co Ltd
Microsatellite Stable Metastatic Colorectal Cancer
Regorafenib Alone or in Combination With Hypofractionated/Low-dose Radiotherapy Plus Toripalimab for Metastatic Colorectal Cancer
The study compares the efficacy and safety of regorafenib alone or in combination with hypofractionated radiotherapy and low-dose radiotherapy (LDRT) plus toripalimab in patients with microsatellite stable metastatic colorectal…
- Trial name
- SLOT (NCT05963490)
- Testing
- Regorafenib, Toripalimab, Radiotherapy
- Where
- China
- Volunteers
- 108 people
- Sponsor
- Fudan University
Intestinal Disorder, Bowel Diseases, Inflammatory
Single Dose Bioavailability and Ethnobridging PK Study in Healthy Subjects
This is a Phase 1, 2-part, open-label study. Part A will be a formulation bridging and food effect study in healthy adult subjects. Part B will be an assessment of pharmacokinetics (PK) in healthy adult Chinese subjects.
- Trial name
- NCT04587713
- Testing
- TD-1473 [Tablet A], TD-1473 [Tablet B]
- Where
- 2 sites in United States
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Theravance Biopharma
Contraception
A Study to Compare 3 Doses of a Hormonal Intra-uterine Device Containing Levonorgestrel and Indomethacin With a Hormonal Intra-uterine Device Containing Only Levonorgestrel to Assess the Effect and Safety of the Combined Components
This study is the first study investigating the combined intrauterine administration of LNG (levonorgestrel) and IND (indomethacin). It is a combined proof-of-concept (PoC) and dose finding (DF) study in pre-menopausal women.
- Trial name
- INDessa (NCT03562624)
- Testing
- BAY98-7443, Levonogestrel (Skyla, BAY86-5028)
- Where
- 7 sites in Germany, United Kingdom
- Volunteers
- 177 people, healthy volunteers welcome
- Sponsor
- Bayer
SARS-CoV-2 Infection
Ad26.COV2.S as a Heterologous Booster in Adults After Single- or Two-Dose of Inactivated COVID-19 Vaccine
This study aims to address evidence gaps regarding the safety, reactogenicity and immune responses of a heterologous boost of a single dose of Ad26.COV2.S (half or full dose) at pre-specified time intervals in recipients who are…
- Trial name
- NCT05109559
- Testing
- Full dose of Ad26.COV2. 5x10^10vp, Half dose of Ad26.COV2. 2.5x10^10vp
- Where
- Thailand
- Volunteers
- 690 people, healthy volunteers welcome
- Sponsor
- Mahidol University
Oncology, Melanoma
Glycan Mediated Immune Regulation With a Bi-Sialidase Fusion Protein (GLIMMER-01)
This is a Phase 1/2, first-in-human, open-label, dose escalation and dose-expansion study of E-602, administered alone and in combination with cemiplimab.
- Conditions
- Oncology, Melanoma, Ovarian Cancer, NSCLC
- Trial name
- GLIMMER-01 (NCT05259696)
- Testing
- E-602, Cemiplimab
- Where
- 13 sites in United States
- Volunteers
- 69 people
- Sponsor
- Palleon Pharmaceuticals, Inc.
Type 2 Diabetes Mellitus
Safety Study of ISIS 325568 in Healthy Volunteers
The primary purpose of this trial is to assess the safety of ISIS 325568 when given at increasing single doses and to assess the safety of the same doses when given multiple times.
- Trial name
- NCT00519727
- Testing
- ISIS 325568
- Where
- Netherlands
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Ionis Pharmaceuticals, Inc.
Rheumatoid Arthritis
Comparative Pharmacokinetic Study of Three Abatacept Products in Male Normal Healthy Volunteers by the Subcutaneous Route
This is a randomised, double-blind, single dose, parallel groups study to compare the PK, immunogenicity, and safety of 3 abatacept products (DRL_AB, RP and RMP) in male NHV.
- Trial name
- NCT06126042
- Testing
- Test Product, Reference product, Reference Medicinal Product
- Where
- 3 sites in United States
- Volunteers
- 330 people, healthy volunteers welcome
- Sponsor
- Dr. Reddy's Laboratories Limited
Healthy Participants
Effects of BMS-986256 at Steady State on the Single Dose Pharmacokinetics of Mycophenolate Mofetil
A Study to Investigate BMS-986256 at steady state and its effect on Mycophenolate Mofetil exposure in Healthy Male Participants
- Trial name
- NCT04039373
- Testing
- BMS-986256, Mycophenolate Mofetil
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Asthma
Clinical Study to Evaluate the Safety, Tolerability and the Concentration of the BDP (Beclomethasone Dipropionate), Active Metabolite of BDP, FF( Formoterol Fumarate) and GB (Glycopyrronium Bromide), After Inhalation of CHF 5993 at Two Different Doses and QVAR®
The study is being conducted to compare the pharmacokinetic (PK) of BDP (and its main active metabolite B17MP), FF, and GB between CHF 5993 BDP/FF/GB 200/6/12.5 µg pMDI and CHF 5993 BDP/FF/GB 100/6/12.5 µg pMDI (pressurized…
- Trial name
- NCT05898984
- Testing
- Test product (T):CHF 5993 BDP/FF/GB 200/6/12.5 µg pMDI, Reference product 1 (R1): CHF 5993 BDP/FF/GB 100/6/12.5 µg pMDI, Reference product 2 (R2): BDP HFA (QVAR REDIHALER®, BDP 80 μg)
- Where
- Belgium
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Overactive Bladder
A Single-Dose Study of the Pharmacokinetics of Vibegron (MK-4618) in Adults With Hepatic Insufficiency (MK-4618-013)
This study will investigate the pharmacokinetics of a single oral dose of vibegron (MK-4618) administered to participants with moderate hepatic insufficiency and healthy participants matched for age, gender, and body mass index…
- Trial name
- NCT01737684
- Testing
- Vibegron
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Healthy
A Study of the Safety and Pharmacokinetics of Single Ascending Oral Doses of INX-08189 in Healthy Subjects
The purpose of this study is to test the safety of different dose strengths of INX-08189 in healthy adults. The study will also look at how rapidly the drug breaks down in the body (pharmacokinetics or PK).
- Trial name
- NCT01159808
- Testing
- INX-08189
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Rheumatoid Arthritis
Safety, Tolerability and Relative Bioavailability Study of BMS-986195 in Healthy Subjects
The purpose of this study is to evaluate the safety profile, tolerability, pharmacokinetics, and pharmacodynamics following single and multiple ascending oral doses of BMS-986195 in healthy subjects, and to assess the relative…
- Trial name
- NCT02705989
- Testing
- BMS-986195
- Where
- Australia
- Volunteers
- 439 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Healthy, Japanese
Study to Evaluate the Pharmacokinetics, Safety, and QTc Effect of AG-348 in Healthy Subjects of Japanese Origin and Non-Asian Origin
The purpose of this Phase I, single-dose, open-label trial is to evaluate the pharmacokinetics, safety, and effect on QTc interval of AG-348 in healthy, adult Japanese and Non-Asian subjects.
- Conditions
- Healthy, Japanese, Non-Asian
- Trial name
- NCT03250598
- Testing
- AG-348
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Agios Pharmaceuticals, Inc.
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