Clinical trials: Phase I
Covid-19 Prevention
A Study of Ad26.COV2.S in Adults (COVID-19)
The purpose of the study is to assess the safety, reactogenicity, and immunogenicity of Ad26.COV2.S at 2 dose levels, administered intramuscularly (IM) as a single-dose or 2-dose schedule, with a single booster vaccination…
- Trial name
- NCT04436276
- Testing
- Ad26.COV2.S
- Where
- 12 sites in United States, Belgium
- Volunteers
- 1,085 people, healthy volunteers welcome
- Sponsor
- Janssen Vaccines & Prevention B.V.
Healthy
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single-Dose Subcutaneous Administration of MEDI-528
A Phase I studyto evaluate the safety and tolerability of escalating subcutaneous (SC) doses of MEDI-528 in to healthy adult volunteers.
- Trial name
- NCT00116168
- Testing
- MEDI-528 0.3 mg/kg, MEDI-528 1 mg/kg, MEDI-528 3 mg/kg
- Where
- 2 sites in United States
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- MedImmune LLC
Healthy Volunteers
Phase 1 Study to Determine Safety, Blood PK and Lung Penetration
Multiple center, double-blind, randomized, placebo-controlled study to see if it is safe to give ACHN-490 Injection for 5 consecutive days, to measure plasma pharmacokinetics, and to determine lung penetration of ACHN-490…
- Trial name
- NCT01034774
- Testing
- ACHN-490 Injection
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Achaogen, Inc.
Healthy Subjects
Mucinex® ER 600 mg Bi-layer Tablet Versus Guaifenesin Immediate Release (IR) 200 mg q4h
Demonstrate bioequivalence of guaifenesin in Mucinex® extended release (ER) 600 mg tablet in normal healthy volunteers compared to the immediate release guaifenesin 200 mg tablet reference product marketed
- Trial name
- NCT03642262
- Testing
- Mucinex®
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Reckitt Benckiser Inc.
Healthy
A Study of Single and Multiple Subcutaneous or Intravenous Doses of ADX-001 in Healthy Adults to Assess Safety, Effects, and Immune Response
This is a phase 1, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of subcutaneous and intravenous…
- Trial name
- NCT07876076
- Testing
- ADX-001
- Where
- Australia
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Adaxion Therapeutics
Healthy Participants
A Phase I Clinical Trial to Evaluate Pharmacokinetics of HS-10504
This is a single-center, open-label, fixed-sequence, self-controlled Phase I clinical study with a planned enrollment of approximately 18 healthy participants.
- Trial name
- NCT07770217
- Testing
- HS-10504, Rifampin
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Healthy
Study to Evaluate HZN-457 in Healthy Volunteers
The purpose of this first in human study is to assess safety, pharmacokinetics, pharmacodynamics, and immunogenicity of single ascending doses of HZN-457.
- Trial name
- NCT05565768
- Testing
- HZN-457
- Where
- 2 sites in New Zealand
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Horizon Therapeutics Ireland DAC
HIV Infections
A Study to Evaluate Pharmacokinetic (PK) and Safety of GSK1265744 in Subjects With Hepatic Impairment and Control Healthy Volunteers
This will be a Phase 1, open-label, parallel group, two-part, single-dose adaptive study in adults with moderate and mild (if needed) hepatic impairment and matched, healthy control subjects with normal hepatic function.
- Trial name
- NCT02354950
- Testing
- GSK1265744 30mg
- Where
- 3 sites in United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Malaria
Study of Pharmacokinetics and Pharmacodynamics of Artesunate in Pregnant Women in the Democratic Republic of Congo
The objective of this study is to assess the pharmacokinetics (PK) and pharmacodynamics (PD) of a standard dose of orally administered artesunate, in order to determine if the current adult dose (200 mg) is appropriate in…
- Trial name
- NCT00538382
- Testing
- Artesunate
- Where
- Democratic Republic of the Congo
- Volunteers
- 51 people, healthy volunteers welcome
- Sponsor
- NICHD Global Network for Women's and Children's Health
Healthy
Relative Bioavailability of BI 44847 in Different Ethnic Groups and Evaluation of Effect of Diet and Acarbose Coadministration on Bioavailability Following Oral Administration of 200 mg BI 44847 in Healthy Male Volunteers
The objectives were to investigate the relative bioavailability of BI 44847 in different racial groups (white, Asian, and African subjects) and to investigate the effect of different types of diet and acarbose coadministration on…
- Trial name
- NCT02211950
- Testing
- BI 44847, Acarbose, Japanese diet
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Factor V Leiden, Prothrombin G20210A
A Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CITY-FXI in Healthy Adults, Adults With FV Leiden or Prothrombin G20210A Mutation, and Adults With a History of Provoked Venous Thromboembolism
This is a first-in-human (FIH), single-center, randomized, double-blind, placebo-controlled, single ascending and multiple dose study evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of…
- Conditions
- Factor V Leiden, Prothrombin G20210A, Venous Thromboembolism (VTE)
- Trial name
- NCT07430397
- Testing
- CITY-FXI
- Where
- United Kingdom
- Volunteers
- 182 people, healthy volunteers welcome
- Sponsor
- City Therapeutics
Psoriasis
Pharmacokinetic, Safety and Immunogenicity Study of CMAB015 and Cosentyx in Healthy Volunteers
This is a randomized, double-blinded, controlled Phase I study of CMAB015 administered by subcutaneous injection. This study will characterize the pharmacokinetic, safety and immunogenicity of CMAB015 versus Cosentyx（Secukinumab…
- Trial name
- NCT05734482
- Testing
- Secukinumab
- Where
- China
- Volunteers
- 130 people, healthy volunteers welcome
- Sponsor
- Taizhou Mabtech Pharmaceutical Co.,Ltd
Healthy Participants
A Study to Evaluate the Safety and Tolerability of Cendakimab in Chinese Healthy Participants
The purpose of this study is to assess the drug levels, safety, and tolerability of cendakimab in healthy male and female Chinese participants.
- Trial name
- NCT05638282
- Testing
- Cendakimab
- Where
- China
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Healthy
Study of PF 04965842 Effect on MATE1/2K Activity in Healthy Participants
This is a Phase 1, randomized, 2 way crossover, open label study of the effect of PF-04965842 on metformin (a probe for MATE1/2K activity) PK in healthy adult participants.
- Trial name
- NCT03796182
- Testing
- Metformin, PF-04965842
- Where
- Belgium
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pfizer
Influenza, Vaccine
Safety and Immunogenicity of a Live-attenuated Universal Flu Vaccine Followed by an Inactivated Universal Flu Vaccine
The clinical study will evaluate safety and the immune response of a prime- boost regimen with a live attenuated influenza vaccine (LAIV) prime and an inactivated split influenza vaccine (IIV) boost with or without adjuvant.
- Trial name
- NCT03300050
- Testing
- cH8/1N1 LAIV, AS03-adjuvanted cH5/1N1 IIV, cH5/1N1 IIV
- Where
- 2 sites in United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- PATH
Healthy
Absorption, Metabolism, and Excretion of CYC065 in Healthy Male Subjects
This will be a Phase 1, open-label, single dose study of the Absorption, Metabolism, and Excretion of CYC065 in healthy male subjects.
- Trial name
- NCT05817890
- Testing
- Fadraciclib
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Cyclacel Pharmaceuticals, Inc.
Effect of Ketoconazole on the PK of NBI-98854 in Healthy Subjects
Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of NBI-98854 in Healthy Subjects
The purposes of this study are to: learn about the safety of the study drug (NBI-98854); learn how subjects tolerate the study drug; and evaluate and compare the pharmacokinetics (PK testing, the study of how the body absorbs…
- Trial name
- NCT01910480
- Testing
- NBI-98854 50 mg capsule once daily, Ketoconazole 400 mg (200 mg twice daily)
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Neurocrine Biosciences
Pulmonary Tuberculosis
Phase 1 ID93 + GLA-SE Vaccine Trial in BCG-Vaccinated Healthy Adult Volunteers
The purpose of this study is to determine the safety, tolerability, and immunogenicity in BCG-vaccinated healthy adult subjects of an investigational vaccine being developed for the prevention of pulmonary tuberculosis.
- Trial name
- NCT01927159
- Testing
- ID93 + GLA-SE
- Where
- South Africa
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Access to Advanced Health Institute (AAHI)
Parkinson's Disease
A Study to Test the Safety, Tolerability, and Pharmacokinetics of UCB0599 in Healthy Study Participants and Patients With Parkinson's Disease (PD)
The purpose of the study is to evaluate the safety and tolerability after administration of multiple doses and the pharmacokinetics (PK) of single and multiple doses of UCB0599 in healthy study participants and participants with…
- Trial name
- NCT04875962
- Testing
- UCB0599
- Where
- 6 sites in United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- UCB Biopharma S.P.R.L.
Healthy
Relative Bioavailability of BI 10773 and Glimepiride in Healthy Male Volunteers
The objective was to investigate whether there was a drug-drug interaction between BI 10773 and glimepiride when co-administered.
- Trial name
- NCT02172261
- Testing
- BI 10773, Glimepiride
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
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