Clinical trials: Phase I
This is a Phase I Study Conducted in Healthy Volunteers
Single Ascending Dose Study of ATH-097 in Healthy Participants
This is a Phase I, A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ATH-097 in Healthy Participants
- Trial name
- NCT07640269
- Testing
- ATH-097
- Where
- Australia
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Atheron Therapeutics, Ltd.
Phase 1 First-in-human Study Involving Healthy Subjects
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TNX-1500 in Healthy Subjects
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TNX-1500 in Healthy Subjects
- Trial name
- NCT07473752
- Testing
- TNX-1500, Keyhole Limpet Hemocyanin (KLH)
- Where
- United States
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Tonix Pharmaceuticals, Inc.
Pharmakokinetic, Open Label
A Phase 1, Open-Label, Parallel-Group, Single-Dose Study To Compare The Pharmakokinetics Of TNX-102 SL (Cyclobenzaprine Hydrochloride Sublingual Tablet) In Non-Elderly Versus Elderly Participants
TNX-102 SL has recently been approved by the United States (US) Food and Drug Administration (FDA) under the brand name TONMYA for the treatment of fibromyalgia.
- Conditions
- Pharmakokinetic, Open Label, Phase 1
- Trial name
- NCT07413367
- Testing
- TNX-102 SL Tablet
- Where
- Canada
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Tonix Pharmaceuticals, Inc.
Early-phase Safety and PK Study of a Vaginal Gel
FIH Lead-in Study of YASO GEL Followed by a Phase 1 Randomized, Double-blind Study to Assess Safety and Pharmacokinetics of YASO GEL
The goal of this clinical trial is to assess the safety and pharmacokinetics of YASO GEL in healthy adult participants. This is a first-in-human study designed to understand how the gel is absorbed and distributed in plasma and…
- Trial name
- PPCM-01 (NCT07281404)
- Testing
- YASO GEL
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Yaso Therapeutics Corporation
This is a Phase I Study Conducted in Healthy Volunteers
AVT03 With Xgeva in Healthy Male Subjects
This study has been designed as a randomized, double-blind, parallel-group study and in healthy adult male subjects of age 28 years to 55 years old.
- Trial name
- NCT05876949
- Testing
- AVT03, Denosumab
- Where
- 3 sites in Poland, South Africa and 1 more
- Volunteers
- 208 people, healthy volunteers welcome
- Sponsor
- Alvotech Swiss AG
Phase 1
A Study to Examine the Effect of Tesofensine and Metoprolol on the 24-hour Mean Heart Rate
A Phase 1 Study to Examine Pharmacodynamic Interaction Between Tesofensine and Metoprolol on 24-hours Mean Heart Rate
- Trial name
- NCT03488719
- Testing
- Metoprolol Succinate 25 MG, Metoprolol Succinate 50 MG, Metoprolol Succinate 100 MG
- Where
- Germany
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Saniona
Phase 1
The Safety, Tolerability, Pharmacokinetics and Food Effects of SHEN211 Tablet in Healthy Subjects
This is a study to evaluate the safety, tolerability, pharmacokinetics, and food effects of SHEN211 tablet in healthy subjects after fasting single or multiple oral administration
- Trial name
- NCT06214858
- Testing
- SHEN211 tablets
- Where
- China
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- JKT Biopharma Co., Ltd.
Phase I and Phase II Metabolites of Berberine
Metabolic Differences Between Dihydroberberine and Micellar Berberine
Differences in metabolites of dihydroberberine (DHB) and micellar berberine (LipoMicel®, LMB) are investigated through a randomized study involving human volunteers.
- Trial name
- NCT06202157
- Testing
- LMB, DHB
- Where
- Canada
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Factors Group of Nutritional Companies Inc.
Phase 1
Safety, Tolerability, and Pharmacokinetic Study of Single Ascending Dose of GV101 in Healthy Subjects
This is a single center Phase 1, placebo-controlled, randomized, double blind, first-in-human (FIH), sequential single ascending dose (SAD) study.
- Trial name
- NCT05068947
- Testing
- GV101
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Graviton Bioscience Corporation
Phase 1 Study, Healthy Volunteers
A Clinical Study to Investigate the Mass Balance and Biotransformation of [14C]DWP14012 in Healthy Chinese Male Subjects
The purpose of this study is to investigate the Mass Balance and Biotransformation of [14C]DWP14012 in Healthy Chinese Male Subjects
- Trial name
- NCT05868967
- Testing
- [14C]DWP14012
- Where
- China
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Phase 1
Comparison of the Relative Oral Bioavailability of GKT137831 Formulated in Capsules or in Tablets
The study will be a comparative oral bioavailability study between GKT137831 capsules and tablets, together with an assessment of the impact of concomitant food intake on the relative bioavailability of GKT137831 tablets.
- Trial name
- NCT03740217
- Testing
- GKT137831
- Where
- France
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Calliditas Therapeutics AB
Phase 1
Study to Evaluate the Pharmacokinetics and Drug-Drug Interactions of Setanaxib in Healthy Adult Male and Female Subjects
The study is a monocentric, open label, phase 1 study to evaluate the pharmacokinetics, and in particular the dose proportionality of setanaxib and its metabolites after a single oral dose (400 mg, 800 mg, 1200 mg, and 1600 mg)…
- Trial name
- NCT04327089
- Testing
- Setanaxib
- Where
- France
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Calliditas Therapeutics AB
Phase 1
PK, Safety and Tolerability Study of AVT02 (Adalimumab) Pre-filled Syringe (PFS) vs, AVT02 Autoinjector (AI)
This study has been designed as a multicentre, randomised, open label study of AVT02 in healthy adult subjects. The study will assess the PK, safety and tolerability of AVT02 in Pre-Filled Syringe compared to AVT02 in…
- Trial name
- NCT03983876
- Testing
- Adalimumab
- Where
- 2 sites in New Zealand
- Volunteers
- 207 people, healthy volunteers welcome
- Sponsor
- Alvotech Swiss AG
Phase 1 Study, Healthy Volunteers
Evaluate the Pharmacokinetics and Safety of DWP14012 Tablet A and Compare Those of DWP14012 Tablet B in Healthy Subjects
The pharmacokinetics (PK) and safety of oral DWP14012 tablet A will be evaluated and compared with those of DWP14012 tablet B in healthy subjects.
- Trial name
- NCT05149274
- Testing
- DWP14012 Tablet A, DWP14012 Tablet B
- Where
- South Korea
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Phase I Study in Healthy Volunteers to Evaluate ECG Effect
Study Evaluating ECG Effects, Safety, Tolerability and Pharmacokinetics of Single Doses of Modufolin (Arfolitixorin) in Healthy Volunteers Tetrahydrofolate in Healthy Male Volunteers
The purpose of this study is to evaluating ECG effects, safety, tolerability and pharmacokinetics of single ascending dose of Modufolin® in healthy male volunteers
- Trial name
- NCT03203564
- Testing
- Modufolin (arfolitixorin)
- Where
- Sweden
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- Isofol Medical AB
Phase 1
A Study to Determine the Effects of PF-04965842 on Midazolam PK in Healthy Volunteers
This is a Phase 1, randomized, 2-way crossover, multiple dose, open label study of the effect of PF-04965842 on midazolam PK in healthy subjects.
- Trial name
- NCT03647670
- Testing
- PF-04965842, Midazolam
- Where
- Belgium
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Pfizer
Clinical Trial, Phase I
Renal Impairment Study
The study will investigate the pharmacokinetics of BAY1142524 in subjects with mild to severe renal impairment compared to age; weight, and gender-matched healthy subjects.
- Trial name
- NCT03402438
- Testing
- Fulacimstat (BAY1142524)
- Where
- Germany
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Bayer
Phase 1, Dengue
Safety Study of Dengushield in Healthy Adults
This Phase 1 study to evaluate the safety of a single dose of Dengushield (dengue monoclonal antibody) in healthy adults.
- Trial name
- NCT03883620
- Testing
- Dengushield 1 mg/kg (Cohort 1) intravenous, Dengushield 3 mg/kg (Cohort 2) intravenous, Dengushield 7 mg/kg (Cohort 3) intravenous
- Where
- Australia
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Serum Institute of India Pvt. Ltd.
Clinical Trials, Phase I as Topic
BAY 1902607: Single Dose Escalation, Safety and Tolerability, Pharmacokinetics, Bioavailability, Food Effect
This study is a first-in-man study that will investigate the safety, tolerability and pharmacokinetics of ascending single doses of BAY1902607 using a placebo controlled, randomized, single center design.
- Trial name
- NCT03212586
- Testing
- BAY1902607
- Where
- Germany
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Bayer
Clinical Trial ,Phase I
Drug-drug Interaction Study: Influence of Vilaprisan on Pharmacodynamics (PD) and Pharmacokinetics (PK) of a Combined Oral Contraceptive (COC)
This study will be performed as a multi-center, randomized, double-blind study in 60 healthy women (2 groups of 30 women) to investigate ovarian activity during simultaneous intake of a COC (containing the estrogen EE and the…
- Trial name
- NCT03210246
- Testing
- Vilaprisan (BAY 1002670), Microgynon
- Where
- 2 sites in Germany
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- Bayer