Clinical trials: Safety and Pharmacokinetics
Healthy Volunteers, Safety
Safety, Tolerability, and Pharmacokinetics of RCS-21 in Healthy Volunteers.
The goal of this clinical trial is to evaluate the safety and tolerability of RCS-21 in healthy volunteers. Participants will be asked to inhale a single dose or multiple doses of RCS-21 and their health status will be constantly…
- Conditions
- Healthy Volunteers, Safety, Tolerability, Pharmacokinetics
- Trial name
- AMIR-21 (NCT06752122)
- Testing
- RCS-21 (SAD), RCS-21 (MD)
- Where
- Germany
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- RNATICS GmbH
Safety, Tolerability
A First-in-Human SAD and MAD Study in HV to Evaluate Oral YR011 Tablet
This is a Phase I clinical trial (protocol number: YR-011-B07) sponsored by Hangzhou Yirui Pharmaceutical Technology Co., Ltd., focusing on the novel oral small-molecule drug YR011 (active ingredient: PA032, a Kv1.3 channel…
- Conditions
- Safety, Tolerability, Pharmacokinetic
- Trial name
- NCT07878481
- Testing
- Kv1.3 potassium channel blocker (PA032, investigational oral small-molecule drug)
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Hangzhou Yirui Pharmaceutical Technology Co., Ltd
Randomized, Open-label
A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
A randomized, multicenter, open-label, active-controlled Phase Ib study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of multiple intravaginal doses of GenSci142 in patients with bacterial…
- Conditions
- Randomized, Open-label, Safety, Tolerability
- Trial name
- NCT07663838
- Testing
- GenSci142 capsule, clindamycin phosphate vaginal cream
- Where
- 9 sites in China
- Volunteers
- 42 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Early Onset Sepsis, Preterm Neonates
Optimizing PreTerm Infant Ampicillin Dosing
The goal of this clinical trial is to learn if preterm infants who are prescribed antibiotics shortly after birth can safely receive a shorter course of antibiotics (24 to 36 hours instead of 48 hours).
- Conditions
- Early Onset Sepsis, Preterm Neonates, NICU, Ampicillin
- Trial name
- OPTI-Amp (NCT07610486)
- Testing
- Ampicillin prescribed by provider per standard of care for evaluation of early onset sepsis
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Duke University
Tolerability, Safety, Immunogenicity and Pharmacokinetic of JS005
Phase I Study of Comparing Single Dose JS005 (Recombinant Humanized Monoclonal Antibody Against IL-17A) With Placebo in Tolerability, Safety, Immunogenicity and Pharmacokinetic in Healthy Volunteers
JS005-001 is one randomized, double-blind, placebo-controlled study to evaluate the tolerability, safety, immunogenicity and pharmacokinetic profile of single dose of JS005 injection in healthy volunteers.
- Trial name
- NCT04220073
- Testing
- JS005 (recombinant humanized monoclonal antibody against IL-17A)
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
Safety, Tolerability
A First-in-Human SAD and MAD Study in Healthy Participants to Evaluate Oral YR011 Tablet
This is a Phase I clinical trial (protocol number: YR-011-B01) sponsored by Hangzhou Yirui Pharmaceutical Technology Co., Ltd., focusing on the novel oral small-molecule drug YR011 (active ingredient: PA032, a Kv1.3 channel…
- Conditions
- Safety, Tolerability, Pharmacokinetics
- Trial name
- NCT07285967
- Testing
- Kv1.3 potassium channel blocker (PA032, investigational oral small-molecule drug)
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Hangzhou Yirui Pharmaceutical Technology Co., Ltd
Healthy Volunteer, Pharmacokinetics
Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination
This is a Phase 1, open-label, three-part, study in approximately 96 healthy adult participants between 18 and 55 years of age (both inclusive) (16 participants in Part 1, 20 participants in Part 2 and , and approximately 60…
- Conditions
- Healthy Volunteer, Pharmacokinetics, Safety, Drug-Drug Interaction (DDI)
- Trial name
- NCT06733675
- Testing
- Ledaborbactam etzadroxil, Ceftibuten, Ceftibuten-ledaborbactam etzadroxil
- Where
- United States
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Basilea Pharmaceutica
Safety Issues, Tolerability
Phase1/2a Study for IPG7236 in Patients With Advanced Solid Tumors
This is a Phase 1/2a first-in-human, multi-center, non-randomized, open-label study to assess the safety, tolerability, pharmacokinetics profile, and preliminary anti-tumor activity of IPG7236 administered orally as a single…
- Conditions
- Safety Issues, Tolerability, Pharmacokinetics
- Trial name
- NCT05142592
- Testing
- IPG7236
- Where
- 7 sites in United States, China
- Volunteers
- 34 people
- Sponsor
- Nanjing Immunophage Biotech Co., Ltd
Pharmacokinetics, Cardiodynamic ECG
A Study to Investigate the Pharmacokinetics and ECG Effects of Linaprazan Glurate
This is a Phase I, single-center, double blind, placebo-controlled, parallel-group, randomized trial designed to evaluate the PK, cardiodynamic ECG effects, safety, and tolerability of single oral doses of linaprazan glurate.
- Conditions
- Pharmacokinetics, Cardiodynamic ECG, Safety, and Tolerability, GERD
- Trial name
- NCT05469854
- Testing
- Linaprazan glurate
- Where
- Sweden
- Volunteers
- 121 people, healthy volunteers welcome
- Sponsor
- Cinclus Pharma Holding AB
Pharmacokinetics, Safety Issues
PK, Safety Study of 90-Day Use of Vaginal Rings Containing Dapivirine and Levonorgestrel
A double-blind, randomized trial (1:1) to characterize the local and systemic pharmacokinetics (PK) of two DPV-LNG vaginal ring formulations
- Conditions
- Pharmacokinetics, Safety Issues, Bleeding
- Trial name
- NCT05041699
- Testing
- IPM Ring-105, IPM Ring-106
- Where
- 2 sites in United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- International Partnership for Microbicides, Inc.
Tolerability of NT-301 Nasal Spray, Pharmacokinetics of NT-301 Nasal Spray
Clinical Trial of Intranasal Delivery of NT-301
The purpose of this research project is to investigate the safety and tolerability of an approved drug (Apomorphine) when administered as a nasal powder spray formulation (NT-301) as well as collect information on how NT-301…
- Conditions
- Tolerability of NT-301 Nasal Spray, Pharmacokinetics of NT-301 Nasal Spray, Safety of NT-301 Nasal Spray, Performance of NT-301 Nasal Spray Device
- Trial name
- APPROVE (NCT06954428)
- Testing
- NT-301 1 mg, NT-301 2 mg
- Where
- 2 sites in Australia
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Nano PharmaSolutions Australia
Pharmacokinetics, Safety
Study in Healthy Subjects to Investigate the Relative Bioavailability and Safety of Pasireotide After Single Subcutaneous Dose Administration Using a Reusable ServoPen With Cartridge as Compared to Administration Using a Syringe Drawn From an Ampule
This single-center Phase 1 study in healthy male and female subjects of 18 to 55 years (inclusive) will follow an open-label, randomized, single-dose, crossover design with 2 intervention periods.
- Trial name
- PASIPHY_PEN (NCT07312643)
- Testing
- Pasireotide cartridge with reusable ServoPen, Pasireotide ampule with syringe
- Where
- Germany
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- RECORDATI GROUP
Breastfeeding, Medication Safety
Medicines in Breast Milk and Estimated Infant Exposure
The MedMilk (Medication concentrations in human Milk) study investigates how selected medicines taken by breastfeeding women are transferred into human milk and whether this may affect the breastfed child.
- Conditions
- Breastfeeding, Medication Safety, Lactation, Drug Exposure Via Breast Milk
- Trial name
- MedMilk (NCT07346716)
- Testing
- Prescription Drugs
- Where
- 3 sites in Denmark
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- University Hospital Bispebjerg and Frederiksberg
Safety, Tolerability
A Phase 1 Study of Y-3 in US Healthy Volunteers.
The goal of this clinical trial is to assess the safety, tolerability, and pharmacokinetic profiles of Y-3 in healthy adult volunteers in the United States.
- Conditions
- Safety, Tolerability, Pharmacokinetic Study in Healthy Volunteers
- Trial name
- NCT06770491
- Testing
- Y-3 for injection
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Neurodawn Pharmaceutical Co., Ltd.
Similarity of Pharmacokinetics and Safety
Comparison of Pharmacokinetics and Safety of HS632 and Xolair® With a Single Injection
To evaluate the bioequivalence of HS632 and Omalizumab (Xolair®) in a single subcutaneous administration in healthy subjects.
- Trial name
- NCT04361812
- Testing
- HS632, Omalizumab (Xolair®)
- Where
- China
- Volunteers
- 1 people, healthy volunteers welcome
- Sponsor
- BioRay Pharmaceutical Co., Ltd.
Safety, Pharmacokinetics
Single Ascending Doses of Kratom in Healthy Nondependent Adults With Opioid Experience
Kratom (Mitragyna speciosa) is a plant often used to self-treat conditions such as pain, coughing, diarrhea, anxiety and depression, opioid use disorder, and opioid withdrawal.
- Conditions
- Safety, Pharmacokinetics, Pharmacodynamics
- Trial name
- NCT06072170
- Testing
- Kratom
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Altasciences Company Inc.
Safety and Pharmacokinetics
Clinical Study of the Safety and Pharmacokinetics of the Drug Fluorothiazinone, a Concentrate for Solution Preparation for Infusion.
A two-stage placebo-controlled open-label safety and pharmacokinetics study of the drug Fluorothiazinone, a concentrate for the preparation of an infusion solution, with participation of adult healthy volunteers.
- Trial name
- NCT07184606
- Testing
- ¼ of the full (target) dose (solution, 5 ml), ½ of the full (target) dose (solution, 10 ml), full dose (solution, 20 ml)
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Bioavailability and Pharmacokinetics, Safety After Oral Intake
Chrysin Bioavailability and Safety
This study seeks to evaluate and compare the pharmacokinetics of a micellar chrysin formulation (LipoMicel Chrysin) with that of a non-micellar chrysin formulation as well as a standard/unformulated chrysin supplement.
- Trial name
- NCT07066839
- Testing
- LipoMicel Chrysin, Non-Micellar Chrysin, Standard/Unformulated Chrysin
- Where
- Canada
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Isura
Safety, Pharmacokinetics
Single and Multiple Intravenous Administrations of Estetrol (E4) in Healthy Adult Volunteers
The Sponsor intends to develop an intravenous (i.v.) formulation of E4 for the treatment of neonatal hypoxic-ischemic encephalopathy (NHIE). E4 has not been administered intravenously to humans yet.
- Trial name
- NCT05460065
- Testing
- single E4 28.3 mg, single E4 94.4 mg, multiple E4 94.4 mg
- Where
- Bulgaria
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- NEURALIS s.a.
Advanced Solid Malignancy, Safety and Tolerability
Safety, Tolerability & Potential Anti-cancer Activity of Increasing Doses of AZD5363 in Different Treatment Schedules
This study is designed to investigate the safety and tolerability of a new drug, AZD5363, in patients with advanced cancer - and to identify a dose and schedule that can be used in the future.
- Conditions
- Advanced Solid Malignancy, Safety and Tolerability, Pharmacokinetics, Pharmacodynamics
- Trial name
- NCT01226316
- Testing
- AZD5363
- Where
- 34 sites in United States, Canada and 8 more
- Volunteers
- 285 people
- Sponsor
- AstraZeneca