Clinical trials: Food Safety
Food Allergy
E-B-FAHF-2, Multi OIT and Xolair (Omalizumab) for Food Allergy
The purpose of this study is testing the use E-B-FAHF-2 Chinese herbal therapy in combination with multi-food oral immunotherapy (OIT) and Xolair® (Omalizumab) to help children and adults who are allergic to foods be able to…
- Trial name
- NCT02879006
- Testing
- Chinese Herbal Medication, Omalizumab, Multi OIT
- Where
- 2 sites in United States
- Volunteers
- 33 people
- Sponsor
- Xiu-Min Li
Healthy Participants, IBD (Inflammatory Bowel Disease)
A Phase I Study of HW201877 in Healthy Subjects
This is a Phase I, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and food effect (FE) of HW201877 in healthy subjects following (1) a single…
- Trial name
- NCT07373457
- Testing
- HW201877 capsules
- Where
- China
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Wuhan Humanwell Innovative Drug Research and Development Center Limited Company
Safety and Tolerability in Healthy Volunteers
Safety and Tolerability Evaluation of BP-LT
This study evaluates the safety and tolerability of the food ingredient BP-LT when added to a daily diet. BP-LT is a stable protein ingredient being functional in the gastrointestinal tract and without systemic absorption.
- Trial name
- NCT07819695
- Testing
- BP-LT
- Where
- Bangladesh
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Bactolife A/S
Gout, Hyperuricemia
SAD,MAD and Food Effect Study of SAP-001 Tablets in Chinese Subjects
To evaluate the pharmacokinetics (PK) profile of single or multiple oral doses of SAP-001 tablets in healthy Chinese subjects and gout patients with hyperuricemia.
- Trial name
- NCT06678581
- Testing
- SAP-001
- Where
- China
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Shanton Pharma Co., Ltd.
Gastroesophageal Reflux
A Pharmacokinetic and Relative Bioavailability Study With Rabeprazole Sodium in Healthy Adult Volunteers
The purpose of the study is to evaluate and compare the pharmacokinetics (blood levels) of 2 different formulations, assess the effect of food on the pharmacokinetics and assess safety of rabeprazole sodium in healthy volunteers.
- Trial name
- NCT01101646
- Testing
- rabeprazole sodium
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Healthy
Single Ascending Dose PK, Oral Bioavailability and Food Effect Study in Healthy Male Volunteers
This 2-part study will assess the effect of formulation and food on the pharmacokinetics of Indoximod in healthy volunteers. Part 1 is a randomized single ascending dose study of indoximod salt formulation to characterize the PK…
- Trial name
- NLG2111 (NCT03852446)
- Testing
- Indoximod HCL (F2) tablets, Indoximod base formulation
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- NewLink Genetics Corporation
Safety, Tolerability, Pharmacokinetics of AEF0217
AEF0217 First-in-Human Phase I Study in 3 Parts (Single and Multiple Ascending Doses, and Food Effect) in Healthy Subjects.
This trial is divided in 3 parts: FIH-SAD (Single Ascending Doses), FIH-MAD (Multiple Ascending Doses) and FIH-FE (Food effects). FIH-SAD will start first.
- Trial name
- AEF0217-101 (NCT05170737)
- Testing
- AEF0217
- Where
- Spain
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Aelis Farma
Glycemic Index
Safety and Efficacy of a Single Dose of a Polyphenol-enriched Brown Seaweed Powder in Human
The primary endpoint of this trial will be to evaluate the safety of a single administration in human of a dose of 500 mg of a polyphenol-rich algal powder when taken 30 minutes before a test meal.
- Trial name
- ICAST (NCT00936754)
- Testing
- Brown seaweed powder
- Where
- Canada
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- innoVactiv Inc.
Healthy Adult Male and Female Volunteers
A Study of ORX489 in Healthy Adult Participants, Aged 18 to 60 Years
Characterize the safety, tolerability and pharmacokinetics of ORX489 following single and multiple doses.
- Trial name
- NCT07413666
- Testing
- ORX489 Tablets
- Where
- United States
- Volunteers
- 212 people, healthy volunteers welcome
- Sponsor
- Centessa Pharmaceuticals (UK) Limited
Shellfish Allergy
Safety of Chitosan as Wine Fining Agent in Shrimp Allergic Patients
Chitosan, the main component of the exoskeletons of crustaceans, mollusks and cephalopods, has been used as a fining agent in wines. However, its safety among patients allergic to shellfish has never been evaluated.
- Trial name
- SWAP (NCT02151279)
- Testing
- Chitosan as wine fining agent, Control
- Where
- 2 sites in Portugal
- Volunteers
- 15 people
- Sponsor
- Universidade do Porto
Fungal Infection
Safety, Pharmacokinetics, Bioavailability, Food Effect, Drug-Drug Interaction Study of APX001 Administered Orally
This is a Phase l double-blind, placebo-controlled, randomized study to investigate the safety, tolerability, pharmacokinetics, bioavailability and food effect of single doses of APX001 administered intravenously and orally…
- Trial name
- NCT02957929
- Testing
- APX001 single IV dose, APX001 single oral dose 1, APX001 single oral dose 2
- Where
- 2 sites in Netherlands
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Basilea Pharmaceutica
Hypertension
Water-only Fasting in the Treatment of Hypertension Patients
This purpose of this study is to examine the safety and feasibility of water-only fasting to treat hypertensive patients.
- Trial name
- NCT04515095
- Testing
- Water-only Fasting
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- TrueNorth Health Foundation
Healthy
A Food Effect Study of CT-L01 After Oral Administration in Healthy Volunteers
This is a phase 1, randomized, open-label, single-dose, crossover, single-center study to evaluate food effect on the pharmacokinetics and safety of CT-L01 after oral administration in healthy volunteers.
- Trial name
- NCT05364164
- Testing
- CT-L01 12.5/1,000 mg
- Where
- South Korea
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Celltrion
Food Allergy, Egg Allergy
Efficacy and Safety of Egg Ladders in Children With IgE-Mediated Hen's Egg Protein Allergy
Hen's Egg Allergy is one of the most common food allergies in early childhood. The first-line treatment is the elimination of hen's egg proteins from the child's or maternal diet.
- Conditions
- Food Allergy, Egg Allergy, Hen Egg Allergy
- Trial name
- NCT07040111
- Testing
- oral food challenge (OFC)
- Where
- 2 sites in Poland
- Volunteers
- 94 people
- Sponsor
- Medical University of Warsaw
Respiratory Syncytial Virus Infections
Study of Single and Multiple Doses of ALS-008176 in Healthy Volunteers
This study will assess the safety, tolerability, and pharmacokinetics (PK) of orally administered ALS-008176 in healthy volunteers.
- Trial name
- NCT01906164
- Testing
- ALS-008176
- Where
- France
- Volunteers
- 101 people, healthy volunteers welcome
- Sponsor
- Alios Biopharma Inc.
Type 2 Diabetes Mellitus
An Ascending Dose, Single/Multiple Dosing, Food Effect Clinical Trial to Evaluate Pharmacokinetics, Safety and Tolerability in Healthy Subjects After Oral Administration of Gemigliptin (Phase I)
To determine the pharmacokinetic properties, safety and tolerability of single/multiple oral administration of Gemigliptin and Food effect in healthy Chinese subjects.
- Trial name
- NCT03864432
- Testing
- Gemigliptin 25mg, Gemigliptin 50mg, Gemigliptin 100mg
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- LG Chem
Healthy Volunteers
A Study to Determine the Effect Food Has on TAK-721 (Budesonide Oral Suspension) in the Body of Healthy Adults
The main aim of this study is to check what the body of a healthy adult who either fasted or had eaten does to TAK-721 and how TAK-721 is distributed in and removed from the body.
- Trial name
- NCT06268301
- Testing
- Budesonide
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Takeda
Paroxysmal Nocturnal Hemoglobinuria, PNH
To Evaluate Safety, Tolerability, PK/PD & Food Effect of Single/Multiple Oral TUL321 Capsules in Healthy Participants.
Phase I Study Evaluating Safety, Tolerability, PK and PD of Single and Multiple Doses of TUL321 Capsule in Healthy Participants and Food Effect on PK
- Trial name
- NCT07760467
- Testing
- Part1: TUL321, Part2: TUL321
- Where
- China
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Zhuhai United Laboratories Co., Ltd.
Gout
A Clinical Trial of HEC93077 in Chinese Healthy Subjects and HUA Patients With Single or Multiple Dosing
A phase 1 clinical trial of HEC93077,to evaluate the safety ,PK,PD and food effect in Chinese healthy subjects and HUA patients after single or multiple dosing.
- Trial name
- NCT05127772
- Testing
- HEC93077
- Where
- China
- Volunteers
- 126 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Anaphylaxis Food
FMXIN002 in Patients at Risk of Anaphylaxis
Study Objective To evaluate the efficacy of FMXIN002, a powder-based intranasal epinephrine spray, for treating anaphylaxis. Study Design Hypothesis: FMXIN002 will terminate anaphylactic reactions as effectively-or more…
- Trial name
- NCT07045701
- Testing
- Epinephrine 4mg nasal powder spray, Adrenalin 0.5mg Injectable Product
- Where
- Israel
- Volunteers
- 30 people
- Sponsor
- Nasus Pharma