Clinical trials: Food Safety
Cow Milk Allergy
Growth, Safety and Tolerance of a Hydrolyzed Protein Infant Formula
This is a single arm, open label, multicenter intervention trial to evaluate growth parameters, cow's milk related symptoms, gastrointestinal tolerance and safety in infants with cow's milk allergy receiving a hydrolyzed protein…
- Trial name
- STORY (NCT05618704)
- Testing
- Hydrolyzed protein infant formula
- Where
- Poland
- Volunteers
- 69 people
- Sponsor
- Nutricia Research
Healthy
Single and Multiple Ascending Dose Study for NKTR-118 and Cross-over Study to Investigate the Effect of Food for NKTR-118 in Japanese Healthy Subjects
The purpose of this study is to evaluate the safety and tolerability of NKTR-118 with healthy subjects.
- Trial name
- Japan SMAD (NCT01318655)
- Testing
- NKTR-118
- Where
- Japan
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Influenza
Evaluation the Safety and Tolerance of GP681 Tablets in Healthy Subjects
Influenza (influenza for short) is an acute respiratory infectious disease caused by influenza virus. The symptoms of the disease range from mild, moderate to severe, and severe cases require hospitalization and may die.
- Trial name
- NCT04729764
- Testing
- GP681 Tablet
- Where
- China
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Healthy
This Study Tests How Different Doses of BI 690517 Are Taken up in the Body of Healthy Men. The Study Also Looks at How Food Influences the Amount of BI 690517 in the Blood
The primary objective of the trial is to investigate the safety and tolerability of BI 690517 in healthy male subjects following oral administration of multiple rising doses over 14 days (MRD part).
- Trial name
- NCT03100916
- Testing
- BI 690517, BI 690517 (Reference)
- Where
- Germany
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Type 2 Diabetes Mellitus
A Study To Investigate The Safety And Metabolism Of GSK376501 In Overweight Subjects
This study represents the first administration of GSK376501 in humans and the goal is to evaluate its initial safety and tolerability. The way the human body processes GSK376501 will also be determined.
- Trial name
- NCT00404963
- Testing
- GSK376501
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Weight Management
Study of GS-4571 in Healthy Participants, Nondiabetic Obese Participants, and Nonobese Participants With Type 2 Diabetes Mellitus (T2DM)
The goal of this clinical study is to learn more about the study drug, GS-4571, and how safe it is in 3 groups, i) Healthy participants, ii) Healthy non-diabetic obese participants, and iii) Non-obese participants with Type 2…
- Trial name
- NCT06562907
- Testing
- GS-4571, Omeprazole
- Where
- 3 sites in United States
- Volunteers
- 134 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Allergic Reactions
Study Evaluating the Safety and Efficacy of Neffy or Intramuscular Adrenalin in Patients With Allergic Reactions After Oral Food Challenge or Allergen Immunotherapy
The study is to assess the safety of neffy or IM Adrenalin in patients who are experiencing allergic reactions after an OFC, allergen Immunotherapy (AIT), or other allergy challenge that may require epinephrine intervention.
- Trial name
- NCT06834165
- Testing
- Neffy, Adrenaline
- Where
- 6 sites in United States
- Volunteers
- 600 people
- Sponsor
- ARS Pharmaceuticals, Inc.
Healthy
Food Trial to Evaluate the Safety and Tolerability of SBD111 in Health Adults
The aim of the trial is to determine if the synbiotic (prebiotic and probiotic), provided twice daily (capsule) is safe and tolerable in healthy adults.
- Trial name
- NCT05206864
- Testing
- Medical Food: SBD111
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Solarea Bio, Inc
Colitis, Ulcerative
A First Time in Human Study to Evaluate the Safety and Tolerability of GSK4381406 in Healthy Participants
This is a 3-part First Time in Human (FTIH) study to evaluate the safety, tolerability, and pharmacokinetics (PK) profile of GSK4381406 following administration of single ascending doses (Part 1), repeat ascending doses (Part 2)…
- Trial name
- NCT05999708
- Testing
- GSK4381406, Indomethacin
- Where
- United Kingdom
- Volunteers
- healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy Volunteer
A Study of the Safety, Tolerability and Pharmacokinetics of Orally-administered GC4702 in Healthy Volunteers
A Phase 1 study will test the safety, tolerability and pharmacokinetics of a single dose of GC4702 when given as an oral tablet.
- Trial name
- NCT03096756
- Testing
- GC4702 dry powder, GC4702 lipid suspension, GC4419 IV
- Where
- Australia
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Galera Therapeutics, Inc.
Healthy Adults
Safety, Tolerability, Pharmacokinetics and Food Effects of Oral EC5026 in Healthy Subjects
The purpose of the study is to provide safety, tolerability, pharmacokinetics and food effects data of a single 8 mg oral dose of EC5026 in healthy subjects.
- Trial name
- NCT04908995
- Testing
- EC5026 oral tablet
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- EicOsis Human Health Inc.
Chronic Cholecystitis, Biliary Dyskinesia
Food-Effect, Single and Multiple Dose Pharmacokinetics, Safety and Tolerability Study of 4-MUST, 128 mg, Tablets in Healthy Volunteers
This open-label study will evaluate the effect of food on the bioavailability of a single dose of 4-MUST, tablets, 128 mg. Additionally, the study will assess the pharmacokinetics, safety, and tolerability of 4-MUST, tablets, 128…
- Trial name
- NCT07594977
- Testing
- 4-MUST
- Where
- Russia
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Valenta Pharm JSC
Healthy Volunteer
Study to Assess the Safety, Tolerability, PK, ECG Effects, Food Effect, and Drug-drug Interaction (DDI) of Hormonal Contraceptives of PTI-428 in Healthy Female Volunteers
This trial will consist of three parts: the first two parts will enroll healthy female volunteers into a single ascending dose (SAD) and multiple ascending dose (MAD) treatment groups.
- Trial name
- NCT02846142
- Testing
- PTI-428, ethinyl estradiol and levonorgestrel
- Where
- United States
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Proteostasis Therapeutics, Inc.
Lipoprotein Disorder Disease
Safety and Tolerance of Increased Doses of HRS-5346 Tablets in Healthy Subjects
This is a randomized, double-blind, placebo-controlled phase I clinical study. The primary objective is to evaluate the safety, tolerability, PK, and PD of single- and multiple-dose HRS-5346 in healthy subjects, and to evaluate…
- Trial name
- NCT06441227
- Testing
- HRS-5346 tablets
- Where
- China
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
Health
A Single and Multiple Dose Study to Explore the Safety Of JNJ-40346527 In Healthy Volunteers
The purpose of this study is to investigate the safety, tolerability and pharmacokinetics (how the drug is absorbed in the body, how it is distributed within the body and it is removed from the body over time) of single and…
- Trial name
- NCT01054014
- Testing
- JNJ-40346527
- Where
- Belgium
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Healthy
A Single and Multiple Dose of Rodatristat Ethyl in Healthy Adult Subjects to Evaluate the Effect of Food and Safety
This is a single and multiple dose food effect study of rodatristat ethyl in healthy subjects
- Trial name
- NCT05684640
- Testing
- Rodatristat Ethyl
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Altavant Sciences GmbH
Healthy Volunteers
Single and Multiple Ascending Dose Study of AMG 378 in Healthy Participants
The main objective of the study is to assess the safety and tolerability of AMG 378 as single or multiple doses in healthy participants.
- Trial name
- NCT06910709
- Testing
- AMG 378
- Where
- 2 sites in United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Amgen
Hepatitis B, Chronic
EYP001a Food Effect Study in Subjects With Chronic Hepatitis B Virus (HBV) Infection
The farnesoid X receptor (FXR) regulates hepatitis B virus replication through the bile acids pathway. EYP001a is a selective, synthetic FXR agonist under development for the treatment of hepatitis B.
- Trial name
- NCT03320616
- Testing
- EYP001a
- Where
- Netherlands
- Volunteers
- 11 people
- Sponsor
- Enyo Pharma
Healthy
Oral Bioavailability,and Food Effect Study and Single Ascending Dose PK 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 an open-label, 3-period, 6-sequence study.
- Trial name
- NCT03372239
- Testing
- Indoximod base formulation, Indoximod HCL (salt) formulation
- Where
- Canada
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- NewLink Genetics Corporation
Healthy Human Volunteers
Single and Multiple Ascending Dose Safety Study of XPF-001 in Healthy Volunteers
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of single and multiple doses of XPF-001 in healthy volunteers. The effect of food on the pharmacokinetics of XPF-001 will also be studied.
- Trial name
- NCT00813670
- Testing
- XPF-001
- Where
- Canada
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Xenon Pharmaceuticals Inc.