Clinical trials: Food Safety
Peanut Allergy
OMEGA Study: A Study of the Safety and Feasibility of Up-titration With INT301 in Adults With Sensitivity to Peanut
This is a phase 1, multi-center, randomized, double-blind, placebo-controlled study in adult participants with peanut allergy. Participants will be randomized in a 3:1 ratio to receive either an escalating dose of INT301 or…
- Trial name
- NCT04603300
- Testing
- INT301
- Where
- 2 sites in United States
- Volunteers
- 32 people
- Sponsor
- Intrommune Therapeutics
Healthy
A Study to Examine the Safety, Tolerability, and Pharmacokinetics of Single- and Multiple-ascending Doses of ACT-1014-6470 in Healthy Subjects
A study to examine the safety, tolerability, and pharmacokinetics of single- and multiple-ascending doses of ACT-1014-6470 in healthy subjects
- Trial name
- NCT04183686
- Testing
- ACT-1014-6470 (SAD), ACT-1014-6470 (MAD), 14C-ACT-1014-6470 microtracer
- Where
- Netherlands
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Idorsia Pharmaceuticals Ltd.
Celiac Disease, Celiac
A Study of the Safety, Efficacy and Tolerability of Nexvax-2 in Patients With Celiac Disease (CeD)
A randomized, double-blind, placebo-controlled clinical study in human leukocyte antigen (HLA)-DQ 2.5+ adults with celiac disease (CeD).
- Conditions
- Celiac Disease, Celiac, Intestinal Disease, Malabsorption Syndromes
- Trial name
- NCT03644069
- Testing
- Nexvax2
- Where
- 41 sites in United States, Australia and 1 more
- Volunteers
- 146 people
- Sponsor
- ImmusanT, Inc.
Inflammatory Bowel Disease (IBD)
Phase I Study of QLS1510 Tablets in Healthy Participants
This is a Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QLS1510 in Healthy participants
- Trial name
- NCT07760077
- Testing
- QLS1510 Tablets
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Shanghai Qilu Pharmaceutical Research and Development Center LTD
Healthy Adult Subjects
A Study of TTYP01 in Healthy Adult Subjects
This is integrated Phase 1, Single centre, Randomized study will be conducted in 3 parts, each with a specific primary objective: Part A: To characterise the safety and tolerability of TTYP01 in healthy adult subjects; Part B: To…
- Trial name
- NCT04370431
- Testing
- TTYP01 single ascending doses, TTYP01, 60 mg, TTYP01, 120 mg
- Where
- Australia
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Shanghai Auzone Biological Technology Co., Ltd.
Nonalcoholic Steatohepatitis (NASH)
Study in Chinese Healthy Adults to Evaluate the Safety, Tolerability and Pharmacokinetics on ZSP1601, and the Effect of Food on ZSP1601 Pharmacokinetics
This study will evaluate the safety, tolerability and pharmacokinetics (PK) of escalating single- and multiple-oral doses of ZSP1601 on fasted condition, and characterize PK of ZSP1601 on an empty stomach (fasted condition) and…
- Trial name
- NCT03392779
- Testing
- ZSP1601 25 mg, ZSP1601 50 mg, ZSP1601 100 mg
- Where
- China
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Guangdong Zhongsheng Pharmaceutical Co., Ltd.
Mental Disorders
Bioequivalence And Effect Of Food And Water On Lamotrigine in Healthy Volunteers
This study intends to demonstrate bioequivalence of two formulations, the effect of food and water on one formulation and safety and tolerability of two formulations of lamotrigine in healthy male and female volunteers
- Trial name
- NCT00449774
- Testing
- Lamotrigine IR tablets, Lamotrigine ODT tablets
- Where
- United States
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
For Participants With Advanced Solid Tumors Failed With Previous Lines of Treatment
Phase 1a/1b BGB-290 for Advanced Solid Tumors.
The study contains Phase 1A and Phase 1B. Phase 1A has Part1 (BID Dose Escalation) and Part2 (QD Dosing Escalation) Evaluation of a cohort of at least three participants completing one cycle of treatment at that dose level and…
- Trial name
- NCT02361723
- Testing
- BGB-290
- Where
- 7 sites in Australia
- Volunteers
- 101 people
- Sponsor
- BeiGene
Healthy Volunteer
AZD8529 Single Ascending Dose Study
This is a study to evaluate safety, tolerability, PK and PD effects of orally administered AZD8529 after single ascending doses
- Trial name
- SAD (NCT00755378)
- Testing
- AZD8529
- Where
- United States
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Obesity
A Study to Investigate the Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Characteristics, and Food Effect of HSG4112
1. Study Objective: The objective of this phase 1 clinical trial is to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic characteristics and food effect of HSG4112 after oral administration in healthy male…
- Trial name
- NCT04732988
- Testing
- HSG4112
- Where
- 2 sites in South Korea
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Glaceum
Healthy Volunteers
ANG-3070 in Healthy Adult Participants
This is a Phase 1 study, to assess the safety, tolerability, pharmacokinetics, and food effect of single and multiple ascending doses of ANG-3070 in healthy adult participants. This study is comprised of 12 cohorts.
- Trial name
- NCT04196179
- Testing
- ANG3070
- Where
- Australia
- Volunteers
- 97 people, healthy volunteers welcome
- Sponsor
- Angion Biomedica Corp
Endometriosis
Study on the Safety of the Drug BAY2395840 at Different Doses, the Way the Body Absorbs, Distributes and Excretes the Drug Including the Effect of Its Formulation (Tablet or Liquid) and the Effect of Food on the Absorption, Distribution or Excretion of the Drug in Healthy Male Participants
Researchers are looking for a better way to treat people who have endometriosis, a condition in which tissue similar to the lining of the uterus starts to grow in places outside of the uterus.
- Trial name
- NCT05517746
- Testing
- BAY2395840 tablet, BAY2395840 oral solution
- Where
- Germany
- Volunteers
- 63 people, healthy volunteers welcome
- Sponsor
- Bayer
Malignant Melanoma
A Study of the Effect of Food on the Pharmacokinetics of Single Dose RO5185426 And the Safety And Efficacy of Continuous Administration in Patients With BRAF V600E Mutation-Positive Metastatic Melanoma
This randomized, open-label, two period crossover study will evaluate the effect of food on the pharmacokinetics of a single dose of RO5185426 and the efficacy and safety of continuous administration in patients with BRAF V600E…
- Trial name
- NCT01264380
- Testing
- RO5185426
- Where
- 10 sites in United States
- Volunteers
- 16 people
- Sponsor
- Hoffmann-La Roche
Dose Finding Study
Safety, Tolerability, and Pharmacokinetics of TAK-438 in Healthy Western Male Subjects, Preliminary Food Effect Analysis, and an Ethnic Comparison With Japanese Subjects
The primary purpose of this study was to evaluate the safety, tolerability, and pharmacokinetics of TAK-438 following single or multiple doses of TAK-438 in healthy Western men, to investigate the effect of food on the…
- Trial name
- NCT02141698
- Testing
- TAK-438, Esomeprazole
- Volunteers
- 73 people, healthy volunteers welcome
- Sponsor
- Takeda
Helicobacter Pylori Infection
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effect of TNP-2198 Capsules After Single Oral Dose in Healthy Participants
This was a single-center, randomized, double-blind, placebo-controlled phase 1 study to evaluate the safety, tolerability, pharmacokinetics of single ascending dose and the food effect on the pharmacokinetics of TNP-2198 capsules…
- Trial name
- NCT06081699
- Testing
- TNP-2198
- Where
- China
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- TenNor Therapeutics (Suzhou) Limited
Healthy Volunteers
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Mitapivat (AG-348) in Healthy Adult Participants
This is a Phase 1, randomized, single-dose, double-blinded, 4-period, crossover study to evaluate the pharmacokinetics, safety, and tolerability of mitapivat in healthy adult participants under fasted and fed (high-fat meal)…
- Trial name
- NCT04472832
- Testing
- Mitapivat 100 mg, Mitapivat 300 mg
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Agios Pharmaceuticals, Inc.
Healthy
A Study in Healthy Men to Test How Different Doses of BI 3031185 Are Tolerated and How Food Influences the Amount of BI 3031185 in the Blood
This trial starts the clinical development of BI 3031185. The single rising dose (SRD) part of the trial investigates safety, tolerability, and pharmacokinetics of a range of single doses of BI 3031185 as basis for further…
- Trial name
- NCT06255340
- Testing
- BI 3031185
- Where
- Germany
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Healthy Volunteer Study
Study Investigating the Safety, Tolerability, PK and Food Effect of BEN8744.
BEN8744 is an experimental new medicine for treating inflammatory bowel diseases such as Ulcerative Colitis. The study will test single and repeated oral doses of BEN8744 or placebo.
- Trial name
- NCT06118385
- Testing
- BEN8744
- Where
- United Kingdom
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- BenevolentAI Bio
RSV Infection
A Study of EDP-323 in Healthy Subjects
This study is a randomized, double-blind, sponsor-open, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of orally administered single and multiple doses of EDP-323 in healthy adult subjects.
- Trial name
- NCT05587478
- Testing
- EDP-323
- Where
- United States
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Enanta Pharmaceuticals, Inc
Healthy
A Study to Investigate Safety and Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of JNJ-54175446 in Healthy Participants
The purpose of this study is to investigate the safety and tolerability of JNJ-54175446 versus placebo after single oral dose administration (ascending dose levels), to determine the maximal tolerated dose (MTD) or the safety and…
- Trial name
- NCT02475148
- Testing
- JNJ 54175446, High fat/high Calorie Breakfast
- Where
- Belgium
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Janssen-Cilag International NV