Clinical trials: Phase I
Safety, Tolerability
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MLN3126 in Healthy Japanese and Non-Japanese Participants
The purpose of this study is to evaluate the safety and tolerability of single and multiple oral dosing of MLN3126 in ascending doses in healthy non-Japanese and Japanese participants.
- Conditions
- Safety, Tolerability, Pharmacokinetics, Pharmacodynamics
- Trial name
- NCT02209506
- Testing
- MLN3126
- Where
- United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Takeda
Epstein-Barr Virus
A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189 in Healthy Adults 18 to 30 Years of Age
The main objective of this trial is to evaluate the safety and immunogenicity of mRNA-1189 after intradermal and intramuscular delivery.
- Trial name
- NCT07478952
- Testing
- mRNA-1189
- Where
- 2 sites in Australia
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Healthy Volunteers
A Study to Assess the Safety of ARGX-213 in Healthy Volunteers
This study aims to assess the safety of ARGX-213 in healthy adults. Another aim is to measure the amount of ARGX-213 in the blood over time to learn how it moves through the body and acts in the body.
- Trial name
- NCT06968338
- Testing
- ARGX-213
- Where
- Canada
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- argenx
Healthy Volunteer
Bioequivalence Study Evaluating the Pharmacokinetics of DMB-3111 and Trastuzumab in Healthy Japanese Male Adults
This study is a randomized Trastuzumab-controlled double-blind parallel-group study.
- Trial name
- NCT02100917
- Testing
- DMB-3111, trastuzumab
- Where
- Japan
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Meiji Seika Pharma Co., Ltd.
Cognition Disorders
This is a Single Ascending Dose Tolerance Study
This is a single rising dose tolerance (Part A) followed by a functional magnetic resonance imaging (Part B)
- Trial name
- NCT01133574
- Testing
- SLV354 capsules
- Where
- United Kingdom
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Abbott
Healthy Volunteers
A Phase I Study of RC1416 Injection
This is a phase I study to evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of RC1416 injection via Subcutaneous Administration in Healthy Adult Volunteers.
- Trial name
- NCT06067490
- Testing
- RC1416(SAD)
- Where
- China
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Nanjing RegeneCore Biotech Co., Ltd.
Healthy Volunteer
Proton Pump Inhibitor (PPI, Rabeprazole) Effect On Tablet Formulation Of Palbociclib
to evaluate the effect of the PPI (rabeprazole) on the PK of a potential commercial tablet formulation of palbociclib
- Trial name
- NCT03220191
- Testing
- Palbociclib, Rabeprazole
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy Volunteers
A Study to Determine the Absolute Bioavailability of BIIB122/DNL151 in Healthy Subjects
This is a single center, non-randomized, open label Phase 1 study to determine the PK and absolute bioavailability of BIIB122 (DNL151) in 2 conditions: following a single, oral dose of BIIB122 (DNL151) and following consecutive…
- Trial name
- NCT05005338
- Testing
- BIIB122 (DNL151), [14C] BIIB122 ([14C] DNL151)
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Biogen
Chikungunya Fever, Chikungunya Virus
Trial of an Inactivated Chikungunya Virus Vaccine
This trial will be a randomized, placebo controlled, double-blind (within dosing group), dose escalation Phase 1 trial, evaluating dosages of 2.5 mcg and 8 mcg of HydroVax-005 CHIKV vaccine given intramuscularly on Day 1 and Day…
- Conditions
- Chikungunya Fever, Chikungunya Virus, Chikungunya
- Trial name
- NCT06669208
- Testing
- HydroVax-005 CHIKV
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Najit Technologies, Inc.
Metastatic Prostate Cancer
A Study of the Absorption, Distribution, Metabolism, and Elimination of Opevesostat (MK-5684) in Healthy Adult Male Participants (MK-5684-008)
This is a study of opevesostat in healthy adult male participants. The purpose of this study is to understand the absorption, distribution, metabolism, and elimination of opevesostat in humans, as well as its pharmacokinetics…
- Trial name
- NCT06566989
- Testing
- [¹⁴C]Opevesostat, Prednisone, Fludrocortisone
- Where
- United Kingdom
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Healthy Volunteers
A Study to Evaluate the Relative Bioavailability of a Pediatric Granule Formulation of Ozanimod in Healthy Adult Subjects
This is a Phase 1, open-label, randomized, parallel-group, single-dose study. Approximately 56 participants will be enrolled and randomized into 1 of the 2 treatment groups, with 28 participants in each treatment group as…
- Trial name
- NCT04528290
- Testing
- Ozanimod
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Celgene
Healthy
Drug Interaction Study of Isavuconazole and Cyclosporine
The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics of cyclosporine in healthy adult subjects.
- Trial name
- NCT01494597
- Testing
- isavuconazole, cyclosporine
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Inc
Visceral Leishmaniasis, Post-kala-azar Dermal Leishmaniasis
Open-Label Safety Study of Three-Antigen Leishmania Polyprotein With Adjuvant MPL-SE in Healthy Adults in India
The purpose of this study is to determine if a vaccine (called Leish-111f + MPL-SE) is safe and whether it can or cannot produce a protective response against visceral leishmaniasis when injected to healthy subjects.
- Trial name
- NCT00486382
- Testing
- Leish-111f + MPL-SE Adjuvant
- Where
- India
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Access to Advanced Health Institute (AAHI)
Dengue
Evaluating the Safety and Protective Efficacy of a Single Dose of a Trivalent Live Attenuated Dengue Vaccine to Protect Against Infection With DENV-2
Infection with dengue viruses is the leading cause of hospitalization and death in children in many tropical Asian countries, and the development of a dengue vaccine is a top health priority.
- Trial name
- NCT02433652
- Testing
- Recombinant live attenuated trivalent dengue vaccine, rDEN2Δ30-7169 vaccine
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Myelofibrosis
A Study to Evaluate Drug-Drug Interaction of TQ05105 Tablets
This is a single-center, open, single-dose, self-controlled phase I clinical trial to evaluate the effects of metabolic enzyme inhibitors/inducers on in vivo metabolic and elimination of TQ05105 tablets, and the safety of…
- Trial name
- NCT06024915
- Testing
- TQ05105 tablets, Itraconazole capsule, Rifampicin Capsule
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Oncology
Pharmacokinetics of Entospletinib in Adults With Normal and Impaired Liver Function
The primary objective of this study is to evaluate the pharmacokinetics of entospletinib (ENTO) and/or its metabolites (if applicable) in participants with impaired hepatic function (stratified by smoking status, as appropriate)…
- Trial name
- NCT02521376
- Testing
- Entospletinib
- Where
- 6 sites in United States, Germany and 1 more
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Healthy Volunteer
A Phase 1 Study to Assess the Effect of ABBV-722 on Ethinyl Estradiol and Levonorgestrel Drug Levels in Healthy Adult Female Participants
The objective of this study is to assess the effect of repeated doses of ABBV-722 on the single dose pharmacokinetics (PK) of ethinyl estradiol and levonorgestrel.
- Trial name
- NCT07502417
- Testing
- Ethinyl Estradiol + Levonorgestrel, ABBV-722
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- AbbVie
Healthy Participants
A Study to Learn How Different Forms of the Study Medicine Called PF-06954522 Are Taken up Into the Blood in Healthy Adults
The purpose of this study is to compare three finished products of PF-06954522 in terms of the uptake into the blood stream. This study is seeking participants who are: Healthy male or female participants aged 18 years or older.
- Trial name
- NCT06393517
- Testing
- PF-06954522 IR (Formulation 1), PF-06954522 MR (Formulation 2), PF-06954522 MR (Formulation 3)
- Where
- 2 sites in United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Pfizer
Healthy
A Study of Idazoxan in Healthy Participants
Four-part study of the safety, tolerability and pharmacokinetics of 3 forms of TR-01-XRR, 1 form of TR-01-XRS, and 1 form of TR-01-XR in healthy adults.
- Trial name
- NCT05727189
- Testing
- TR-01-XRR (1), TR-01-XRR (2), TR-01-XRR (3)
- Where
- 2 sites in Australia
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Terran Biosciences Australia Pty Ltd
Healthy Volunteer
A Study to Evaluate the Pharmacokinetics of Single Oral Doses of Ozanimod in Healthy Adult Chinese Subjects
This is a Phase 1, open-label, single-dose study. Approximately 24 Chinese healthy adult subjects will be enrolled to receive a single oral dose of ozanimod 0.46 mg or 0.92 mg (12 subjects per dose cohort).
- Trial name
- NCT04211558
- Testing
- Ozanimod
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Celgene
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