Clinical trials: Phase 1
Healthy Volunteers
A Study Assessing the Safety of Oral ATH-399A in Healthy Adult Participants
This study will evaluate the safety, tolerability and pharmacokinetics of single and multiple doses of ATH-399A in healthy adults and also evaluate the effect of food on ATH-399A in order to develop mechanism-based and/or…
- Trial name
- NCT06088784
- Testing
- ATH-399A, ATH-399A 10 mg, 5 mg ATH-399A capsule
- Where
- Canada
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- HanAll BioPharma Co., Ltd.
Normal Drug Tolerance
Safety and Pharmacokinetic (PK) Study to Assess Bronchopulmonary Disposition of IV Eravacycline (TP-434) in Healthy Men and Women
This is a phase 1, open-label, randomized pharmacokinetic and safety study in healthy adult subjects, who will undergo bronchoscopy and bronchoalveolar lavage (BAL) after receiving seven (7) doses of 1.0 mg/kg IV TP-434.
- Trial name
- BAL (NCT01989949)
- Testing
- TP-434 (Eravacycline) reconstituted and administered via an IV infusion
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Tetraphase Pharmaceuticals, Inc
Nausea
Study to Evaluate Rate of Nausea in Healthy Premenopausal Female Subjects Treated With Single Dose of Bremelanotide Alone or With Zofran
This is a Phase 1, randomized study to evaluate the rate of nausea in healthy premenopausal study participants following a single dose of BMT with or without a single 8 mg po dose of Zofran given 30 minutes before BMT dosing.
- Trial name
- NCT03973047
- Testing
- Bremelanotide, Zofran
- Where
- United States
- Volunteers
- 228 people, healthy volunteers welcome
- Sponsor
- AMAG Pharmaceuticals, Inc.
Schistosomiasis
Study to Evaluate the Safety of the Vaccine Prepared sm14 Against Schistosomiasis
This is a phase I, open-label, single arm trial, which aims to assess the safety of the vaccine prepared sm14 in healthy subjects.
- Trial name
- NCT01154049
- Testing
- sm14 antigen plus adjuvant GLA
- Where
- Brazil
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Oswaldo Cruz Foundation
Healthy Volunteers
Randomized, Double-Blind, Placebo-Controlled, MAD Study to Assess the Safety, Tolerability, and Pharmacokinetics of SXC 2023
This is a randomized, double-blind, placebo-controlled, multiple ascending dose study conducted at one study center in the United States.
- Trial name
- NCT03542435
- Testing
- SXC-2023
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Promentis Pharmaceuticals, Inc.
Growth Failure, Growth Hormone Deficiency
r-hGH Liquid Multidose Versus Freeze-dried Multidose Bioequivalence Trial
The primary objective of the trial was to assess the bioequivalence for two concentrations (5.83 mg/mL and 8 mg/mL) of the new r-hGH liquid multidose formulation using the r hGH freeze-dried multidose formulation (Saizen® 8 mg…
- Trial name
- NCT01034735
- Testing
- r-hGH liquid (Saizen), r-hGH freeze-dried
- Where
- Germany
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- EMD Serono
Healthy Participants, Gastrointestinal Neoplasms
A Study to Investigate the Effects of Impaired Hepatic Function on Velzatinib
This study evaluates the pharmacokinetics (PK), safety, and tolerability of velzatinib in participants with mild, moderate, and severe hepatic impairment (HI) and participants with normal hepatic function.
- Trial name
- NCT07859735
- Testing
- Velzatinib
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Healthy
[14C] Icosabutate -A Phase I Absorption, Metabolism and Excretion Study
[14C]PRC-4016 (Icosabutate) - A Phase I, Open-Label Study of the Absorption, Metabolism and Excretion Following Oral Dosing to Healthy Male Subjects.
- Trial name
- NCT02373176
- Testing
- [14C]PRC 4016 (Icosabutate)
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Pronova BioPharma
Healthy, HIV
Safety and Pharmacokinetics (PK) of a Polyurethane Tenofovir Disoproxil Fumarate (TDF) Vaginal Ring (TDF IVR-002)
This prospective, two-site, two-arm, randomized, single-blind, placebo-controlled trial will examine the safety and pharmacokinetics (PK) of a polyurethane tenofovir disoproxil fumarate (TDF) vaginal ring when used continuously…
- Trial name
- TDF IVR-002 (NCT02762617)
- Testing
- Tenofovir disoproxil fumarate intravaginal ring
- Where
- 2 sites in United States, Kenya
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Marla Keller
Infections
Assess the Plasma, Epithelial Lining, and Alveolar Macrophage Concentrations of Intravenous Meropenem-Pralubactam (Meropenem/FL058) in China Healthy Adult Participants
The goal of this clinical trial is to evaluate the Epithelial Lining Fluid concentrations and permeability of Intravenous Meropenem-Pralubactam(Meropenem/FL058) in China Healthy Adult Participants.
- Trial name
- NCT07124468
- Testing
- Meropenem-Pralubactam
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Renal Impairments
A Study to Evaluate EDG-7500 in People With Renal Impairment
The purpose of this Phase 1 study is to understand and compare the amount of EDG-7500 in the blood after a single dose in participants with different levels of kidney function impairment versus participants with normal kidney…
- Trial name
- NCT07034768
- Testing
- EDG-7500
- Where
- 2 sites in United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Edgewise Therapeutics, Inc.
Renal Impairment
Study to Evaluate the Effect of Renal Impairment and Dialysis Treatment on the Pharmacokinetics of a Single 3 mg Cytisinicline Dose
The primary objectives of this study are: 1. To obtain information on the pharmacokinetics of cytisinicline following a single oral dose in subjects with varying degrees of renal impairment relative to matched controls with…
- Trial name
- NCT05631938
- Testing
- cytisinicline
- Where
- 6 sites in Portugal, Spain
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Achieve Life Sciences
End-Stage Renal Disease (ESRD)
A Study of Avacopan in Participants With Normal Renal Function and Participants With End-Stage Renal Disease (ESRD)
The primary objective of the study is to evaluate the pharmacokinetics (PK) of avacopan and metabolite (M1) after a single dose of avacopan in participants with normal renal function and participants with ESRD requiring…
- Trial name
- NCT06468826
- Testing
- Avacopan
- Where
- 2 sites in United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Amgen
Healthy Male Subjects
A Study to Evaluate the PK Similarity of AK112 in Healthy Chinese Male Subjects
The purpose of this study is to evaluate the pharmacokinetic (PK) similarity of AK112 (an anti-PD-1/VEGF bispecific antibody) from the proposed new manufacturing site and the approved original site in healthy male subjects.
- Trial name
- NCT07340476
- Testing
- AK112 (New Site), AK112 (Original Site)
- Where
- China
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Akeso
Healthy Subjects
PK and Safety Comparison of DWJ1511 and DWC202501 in Healthy Volunteers
PK and Safety Comparison of DWJ1511 and DWC202501 in Healthy Volunteers
- Trial name
- NCT07144176
- Testing
- DWJ1511, DWC202501
- Where
- South Korea
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Healthy
Safety and Tolerability of Repeat Doses of ACU-4429 in Healthy Subjects
The purpose of this study is to evaluate the safety and tolerability of repeated doses of a new investigational drug (ACU-4429) in healthy human subjects.
- Trial name
- NCT00942240
- Testing
- ACU-4429
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Kubota Vision Inc.
Healthy Participant
A Study to Compare Two Tablet Formulations of Study Medicine Atirmociclib in Healthy Participants
The purpose of this study is to understand bioequivalence (medicines that may have different names or be made in different ways, but have the same effect on the body) of the current PF-07220060 tablet formulation and the proposed…
- Trial name
- NCT07130097
- Testing
- PF-07220060
- Where
- United States
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Pfizer
Herpes
A Phase I Clinical Trial of Recombinant Herpes Zoster Vaccine (CHO Cell)
To evaluate the safety and tolerability of different dosages of recombinant zoster vaccine (CHO cell) when administered to adults aged 40 years and older.
- Trial name
- NCT07633197
- Testing
- Recombinant Herpes Zoster Vaccine
- Where
- China
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Changchun BCHT Biotechnology Co.
Health, Subjective
Evaluate the Safety and Tolerability of a Single-dose Administration of BMI2004 Inj.
A phase I clinical trial to evaluate the safety and tolerability of a single-dose administration of BMI2004 Inj. (hyaluronidase, recombinant) in healthy adults
- Trial name
- NCT05922813
- Testing
- BMI2004, 0.9% NaCl
- Where
- South Korea
- Volunteers
- 257 people, healthy volunteers welcome
- Sponsor
- BMI Korea
Healthy Volunteers, Pharmacokinetics
Drug-drug Interaction Study Using Rosuvastatin as a Breast Cancer Resistant Protein (Efflux Transporter), Organic Anion-transporting Polypeptide (OATP)1B1, and OATP1B3 (Uptake Transporters) Probe Substrate
Evaluation of the potential perpetrator effect of BAY1841788 (ODM-201) on rosuvastatin pharmacokinetics. PK of BAY1841788 (ODM-201) after single and repeated administration in male and female subjects.
- Conditions
- Healthy Volunteers, Pharmacokinetics, Drug Interaction
- Trial name
- NCT02671097
- Testing
- Rosuvastatin, BAY1841788 (ODM-201)
- Where
- Germany
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Bayer
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