Clinical trials: Human Healthy Volunteers
Infection, Human Immunodeficiency Virus, HIV Infections
Pharmacokinetic Study of Cabotegravir Long-acting in Healthy Adult Volunteers
Cabotegravir (CAB) long-acting (LA) is a promising candidate for human immunodeficiency virus (HIV) pre exposure prophylaxis (PrEP) due to its potent antiretroviral activity and infrequent dosing requirements.
- Trial name
- NCT02478463
- Testing
- Cabotegravir tablet 30 mg once daily for 28 days., Cabotegravir injection 3 mL (200 mg/mL) IM given once on Day 1.
- Where
- 2 sites in United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Safety, Tolerability
Safety, Tolerability and Immune Effects of the Nasal Foralumab in Healthy Human Volunteers
The goal is to establish the safety of administration of nasal foralumab to healthy volunteers in escalating doses to determine the dose at which immune effects are observed.
- Trial name
- NCT06879067
- Testing
- Foralumab Nasal
- Where
- United States
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Tiziana Life Sciences LTD
Retinitis Pigmentosa
A Phase 1/2 Study in Healthy Volunteers and Participants With Autosomal Dominant Retinitis Pigmentosa (RHO-adRP)
This integrated Ph1/2 clinical study is to assess the safety, tolerability and pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of OCT-980 in healthy volunteers and participants with RHO-adRP.
- Trial name
- NCT07408232
- Testing
- Phase 1b/2: Cohort 1 - OCT-980 Tablet, Phase 1b/2: Cohort 2 - OCT-980 Tablet, Phase 1b/2: Cohort 3 - OCT-980 Tablet
- Where
- 2 sites in United States
- Volunteers
- 18 people
- Sponsor
- Octant, Inc.
Hepatitis C
Study Assessing the Effects of Darunavir/Ritonavir or Lopinavir/Ritonavir on the Pharmacokinetics of Daclatasvir in Healthy Participants
The purpose of this study is to determine whether multiple doses of darunavir/ritonavir or lopinavir/ritonavir affect the pharmacokinetics of daclatasvir in healthy participants.
- Trial name
- NCT02159352
- Testing
- Daclatasvir, Darunavir, Ritonavir
- Where
- United States
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Healthy
Study in Healthy Volunteers to Evaluate a Human Monoclonal Antibody Against Hepatitis C
This is a phase I, open-label, dose escalation study to evaluate the safety of MBL-HCV1 in healthy adult volunteers. Eligible volunteers will be admitted to a phase 1 unit for study infusion.
- Trial name
- MBL-HCV1 (NCT00952263)
- Testing
- MBL-HCV1
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- MassBiologics
No Evidence of Disease
Celecoxib in Preventing the Damaging Effects of Sunburn in Healthy Volunteers
This randomized clinical trial studies if celecoxib will prevent the damaging effects of sunburn in healthy volunteers. Exposure to ultraviolet light can induce erythema, sunburn or skin redness caused by inflammation.
- Trial name
- NCT02099136
- Testing
- UV Light Therapy, Celecoxib, Biopsy
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- National Cancer Institute (NCI)
Influenza
A Phase 2 Influenza A Challenge Study Following Oral Administration of an H1N1 HA Ad-Vector Seasonal Flu Vaccine
A Phase 2 Randomized, Placebo- and Active-Controlled, Human Influenza A/California/04/2009 (H1N1) Challenge Study Following Administration of an Oral H1N1 Hemagglutinin (HA) Adenoviral-Vector Based Seasonal Influenza Vaccine and…
- Trial name
- NCT02918006
- Testing
- VXA-A1.1, Fluzone®
- Where
- United States
- Volunteers
- 179 people, healthy volunteers welcome
- Sponsor
- Vaxart
Healthy
First-in-Human Single Ascending and Multiple Dose of GLPG0634
The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) and multiple (MD) oral doses of GLPG0634 compared to placebo (with and without food).
- Trial name
- NCT01179581
- Testing
- GLPG0634
- Where
- Belgium
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Lakefront Biotherapeutics NV
Malaria, Falciparum
Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of LAI MMV055 Alone and in Combination With MMV371 in Healthy Participants
This is a single-centre, participant- and investigator-blind, randomised, placebo controlled, single ascending dose study to assess the safety, tolerability and PK of a single dose of IM depot injection(s) of LAI formulations of…
- Trial name
- NCT07011511
- Testing
- MMV055 Dose 1, MMV055 Dose 2, MMV055 Dose 3
- Where
- United Kingdom
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Medicines for Malaria Venture
Healthy
Objective Markers of Pain Perception in Humans
Determine objective markers of pain perception remains a major scientific and medical issue. Various tools have been proposed to objectify pain, but their adaptability to different clinical contexts are limited.
- Trial name
- NCT02559999
- Testing
- Painful tonic stimuli, non-painful stimuli
- Where
- 2 sites in France
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne
Human Immunodeficiency Virus Type 1 (HIV-1)
Bioequivalence Study of Individual Atazanavir and Cobicistat Compared With Atazanavir in Fixed-dose Combination With Cobicistat
The purpose of the study is to compare the pharmacokinetics and bioequivalence of atazanavir in a fixed-dose combination with cobicistat with that of atazanavir coadministered with cobicistat as single agents.
- Trial name
- Atazanavir (NCT01837719)
- Testing
- Atazanavir, Cobicistat, Atazanavir/Cobicistat FDC
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Healthy Volunteers
A Study of Plasma-Derived Human Butyrylcholinesterase Administered Intramuscularly
The purpose of this placebo-controlled study is to evaluate the safety, tolerability and pharmacokinetics of a single dosage of human butyrylcholinesterase (HuBChE) in healthy adults.
- Trial name
- NCT00333528
- Testing
- Human butyrylcholinesterase (HuBChE) derived from human plasma
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Baxalta now part of Shire
Healthy
A Crossover Study Assessing the Pharmacokinetics, Pharmacodynamics, and Safety of Recombinant Human Insulin
The purpose of this study is to assess the pharmacokinetics, pharmacodynamics, and safety of recombinant human insulin. The study will consist of 2 phases.
- Trial name
- NCT00358553
- Testing
- Insulin
- Where
- Germany
- Volunteers
- healthy volunteers welcome
- Sponsor
- Baxter Healthcare Corporation
Influenza
Safety, Tolerability, and Immunogenicity Study of a Cell-based Virosomal Influenza Vaccine in Healthy Adults
The purpose of this study is to examine the safety and tolerability after administration of trivalent and quadrivalent cell-based virosomal influenza vaccine in healthy adults.
- Trial name
- NCT02148328
- Testing
- Trivalent virosomal influenza vaccine, Commercial vaccine 1, Quadrivalent virosomal influenza vaccine
- Where
- 4 sites in Belgium
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Crucell Holland BV
Hepatitis C, Hypertension
A Drug Interaction Study of Boceprevir in Combination With Amlodipine or Diltiazem in Healthy Volunteers
The purpose of this study is to evaluate the pharmacokinetic interactions between the hepatitis C NS3 protease inhibitor boceprevir and the calcium channel blockers amlodipine and diltiazem in healthy volunteers.
- Trial name
- NCT01549496
- Testing
- Amlodipine, Diltiazem
- Where
- Canada
- Volunteers
- healthy volunteers welcome
- Sponsor
- Ottawa Hospital Research Institute
Healthy Subjects
Pharmacokinetic and Pharmacodynamic Effects of Insulex® R in Comparison to Humulin® R in Healthy Subjects
The goal of this clinical trial is to evaluate whether Insulex® R demonstrates similar pharmacokinetic (PK) and pharmacodynamic (PD) profiles compared to Humulin® R after a single subcutaneous dose of 0.3 units/kg in healthy…
- Trial name
- NCT07364669
- Testing
- Insulex® R (soluble human insulin, biosimilar), Humulin® R (soluble human insulin, biosimilar)
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Laboratorios Pisa S.A. de C.V.
Healthy Volunteers
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Bioavailability, and Food-effects of EA1080 in Healthy Caucasian and Japanese Male Participants
The primary purpose of the study is to evaluate the safety and tolerability of EA1080 following single and multiple ascending oral doses in healthy Caucasian and Japanese male participants.
- Trial name
- NCT04223960
- Testing
- EA1080
- Where
- United Kingdom
- Volunteers
- 184 people, healthy volunteers welcome
- Sponsor
- EA Pharma Co., Ltd.
Healthy Volunteers
Safety, Pharmacokinetic and Pharmacodynamic Study of the CDK 4/6 Inhibitor G1T28-1
This first-in-human (FIH) study will provide the first safety, PK, and PD data of G1T28-1 in humans and will allow further development of G1T28 1 in patients with cancer to reduce chemotherapy-induced myelosuppression.
- Trial name
- NCT02243150
- Testing
- G1T28-1 (CDK 4/6 Inhibitor)
- Where
- Netherlands
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- G1 Therapeutics, Inc.
Hepatitis B, Infectious Disease
A Study in Healthy Volunteers
This is three part study that will, in part one assess the safety, tolerability, and PK of a single dose of CRV431 in healthy volunteers.
- Conditions
- Hepatitis B, Infectious Disease, Liver Diseases
- Trial name
- NCT03596697
- Testing
- CRV431, TDF
- Where
- 3 sites in United States
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- Hepion Pharmaceuticals, Inc.
Healthy Volunteer
A Study to See How BIIB122 Works in the Human Body, and to Evaluate it's Safety, and Tolerability in Healthy Adult Japanese, Chinese, and Caucasian Participants
The study will be looking at an investigational drug, BIIB122, in healthy adult Japanese, Chinese, and Caucasian participants. The main goal of the study is to compare the drug level achieved in the body, between the different…
- Trial name
- NCT05229562
- Testing
- BIIB122
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Biogen