Clinical trials: Dose Escalation and Safety
COVID-19, Coronavirus Infections
Safety, Tolerability, and Immunogenicity of Trivalent Coronavirus Vaccine Candidate VBI-2901e With E6020 Adjuvant
VBI-2901e is an investigational vaccine candidate that uses enveloped virus-like particles (eVLPs) to express the spike proteins of three coronaviruses: SARS-CoV-2 (the virus that causes COVID-19 disease), SARS-CoV-1 and…
- Trial name
- NCT05614245
- Testing
- VBI-2901e
- Where
- 4 sites in Canada
- Volunteers
- healthy volunteers welcome
- Sponsor
- VBI Vaccines Inc.
Healthy
Safety and Immunogenicity Of A Recombinant H5N1 Vaccine In Adults
The purpose of this study is to assess the safety, immunogenicity,and tolerability of a H5N1 Vaccine in healthy adults.
- Trial name
- NCT01250795
- Testing
- HAI-05 Influenza Vaccine, Saline
- Where
- 2 sites in United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Fraunhofer, Center for Molecular Biotechnology
Anesthesia, Sedation
A Study Evaluating the Safety, Pharmacodynamics and Pharmacokinetics of HSK3486 in Healthy Subjects.
This is the first clinical trial of HSK3486 and will be conducted in healthy volunteers to determine the safety, tolerability (including pain on injection), and PK(only to be assessed for subjects who are randomized to HSK3486 in…
- Trial name
- NCT04033939
- Testing
- HSK3486, Propofol
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Sichuan Haisco Pharmaceutical Group Co., Ltd
Healthy
Safety/Tolerability and Pharmacokinetics/Pharmacodynamics of YH4808 After Oral Administration in Healthy Male Subjects
First in human study
- Trial name
- NCT01007019
- Testing
- YH4808 30mg, YH4808 50mg, YH4808 100mg
- Where
- South Korea
- Volunteers
- 134 people, healthy volunteers welcome
- Sponsor
- Yuhan Corporation
Cancer, Neoplasms
A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK2816126 in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma, Transformed Follicular Lymphoma, Other Non-Hodgkin's Lymphomas, Solid Tumors and Multiple Myeloma
This is an open-label, multicenter, 2-part study to determine the recommended Phase 2 dose (RP2D) for GSK2816126 given twice weekly by intravenous (IV) infusion.
- Trial name
- NCT02082977
- Testing
- GSK2816126
- Where
- 5 sites in United States, France and 1 more
- Volunteers
- 41 people
- Sponsor
- GlaxoSmithKline
Bacterial Infection
Safety Study of Intravenous Ertapenem in Combination With Zidebactam (WCK 6777)
This is a Phase 1, single center study to investigate the safety, tolerability, and pharmacokinetics (PK) of three dose-level groups of WCK 6777 (ERT and ZID combination), and two dose-level groups of ERT alone and ZID (WCK 5107)…
- Trial name
- NCT05645757
- Testing
- Ertapenem, WCK 6777, Zidebactam
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Transthyretin Mediated Amyloidosis (ATTR)
Trial to Evaluate Safety and Tolerability of ALN-TTR01 in Transthyretin (TTR) Amyloidosis
The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of ALN-TTR01 in patients with transthyretin (TTR) mediated amyloidosis (ATTR).
- Trial name
- NCT01148953
- Testing
- ALN-TTR01, Sterile Normal Saline (0.9% NaCl)
- Where
- 4 sites in France, Portugal and 2 more
- Volunteers
- 32 people
- Sponsor
- Alnylam Pharmaceuticals
Healthy Volunteers
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Donidalorsen (IONIS-PKK-LRx) Administered Subcutaneously to Healthy Volunteers
The purpose is to assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Donidalorsen administered subcutaneously to Healthy Volunteers
- Trial name
- NCT03263507
- Testing
- Donidalorsen
- Where
- Canada
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Ionis Pharmaceuticals, Inc.
Phenylketonurias
AAV Gene Therapy Clinical Study in Adult Classic PKU (PHEdom)
This is a Phase 1/2, open-label, multiple-center, dose escalation and cohort expansion study to evaluate the safety and efficacy of NGGT002 in adult subjects with classic Phenylketonuria (PKU).
- Trial name
- NCT06332807
- Testing
- NGGT002
- Where
- 5 sites in United States
- Volunteers
- 12 people
- Sponsor
- NGGT INC.
Anthrax
Single Dose, Weight-Based, Dose-Escalation Study With Intravenous ETI-204 in Adult Volunteers
This study will determine the safety and PK of a single IV dose of ETI-204 in subjects 18 to 65 years of age. Three cohorts will be studied with subjects receiving ETI-204.
- Trial name
- NCT01453907
- Testing
- ETI-204, "Anthim"
- Where
- United States
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Elusys Therapeutics
HPV
PANHPVAX, Study of a New HPV Vaccine in Healthy Volunteers
First-in-human, phase I, single-center, open-label, dose-escalation trial in healthy volunteers. Investigation of safety and tolerability of ascending doses of PANHPVAX, a vaccine against human papilloma L2 antigens formulated…
- Trial name
- PANHPVAX (NCT05208710)
- Testing
- Vaccination with PANHPVAX 10µg, Vaccination with PANHPVAX 40µg, Vaccination with PANHPVAX 100µg
- Where
- Germany
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- German Cancer Research Center
Carcinoma, Renal Cell
A Study of Belzutifan (MK-6482) in Participants With Advanced Clear Cell Renal Cell Carcinoma (MK-6482-018)
The goal of this study is to evaluate the safety, tolerability and pharmacokinetics of escalating doses of belzutifan as second line positive (2L+) treatment in participants with advanced clear cell renal cell carcinoma (ccRCC).
- Trial name
- NCT04846920
- Testing
- Belzutifan
- Where
- 4 sites in United States
- Volunteers
- 29 people
- Sponsor
- Merck Sharp & Dohme LLC
NSCLC, Prostate Cancer
Clinical Trial of TB511 in Advanced Solid Tumors
1. Study population [TB511 Monotherapy Cohort for Phase 1 and Phase 2a Clinical Trial] Patients with advanced solid tumors who are either refractory or intolerant to standard of care (SoC).
- Conditions
- NSCLC, Prostate Cancer, Colorectal Cancer, Hepatocellular Carcinoma
- Trial name
- NCT06400160
- Testing
- TB511, Keytruda
- Volunteers
- 12 people
- Sponsor
- Twinpig Biolab, Inc.
Safety
Single and Multiple Dose Escalation Trial of an Intravenous Antibiotic RC-01
A Phase 1 study of the safety, tolerability and pharmacokinetics of a new antibiotic (RC-01). In Part 1 cohorts of healthy adults will participate in a single dose escalation study of increasing intravenous doses of RC-01.
- Trial name
- NCT03832517
- Testing
- Single intravenous doses of RC-01, Multiple intravenous doses of RC-01
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Recida Therapeutics, Inc.
Open-angle Glaucoma
Single-dose Study of ANX007 in Participants With Primary Open-angle Glaucoma
This is a multi center, open-label, single dose, safety study. Approximately 9 to 15 participants with open-angle glaucoma are assigned into 3 sequential dose-levels and will receive ANX007 administered as single, IVT injections.
- Trial name
- NCT03488550
- Testing
- ANX007
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Annexon, Inc.
Advanced Solid Tumor, Cutaneous Tumor
Phase I Study of Tolododekin Alfa (ANK-101) in Advanced Solid Tumors
This is a Phase 1, multicenter, open-label dose escalation study to determine the safety and tolerability of intratumoral (IT) injection of tolododekin alfa (ANK-101) in participants with advanced solid tumors who have progressed…
- Conditions
- Advanced Solid Tumor, Cutaneous Tumor, Subcutaneous Tumor, Malignant Solid Tumor
- Trial name
- ANCHOR (NCT06171750)
- Testing
- tolododekin alfa, Cemiplimab
- Where
- 5 sites in United States, Canada
- Volunteers
- 97 people
- Sponsor
- Ankyra Therapeutics, Inc
Healthy
Single Rising Dose Study (Intravenous Infusion and Subcutaneous Injection) of BI 655064 in Healthy Male Volunteers
To investigate safety and tolerability of BI 655064 in healthy male volunteers following intravenous infusion of escalating single doses and following subcutaneous injection.
- Trial name
- NCT01510782
- Testing
- BI 655064
- Where
- Germany
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Cancer, Solid Tumors
Study of XL418 in Adults With Solid Tumors
The purpose of this study is to evaluate the safety and tolerability of XL418 in subjects with solid tumors. XL418 is a new chemical entity that inhibits a spectrum of targets, including Akt and p70S6K, that mediate PI3 Kinase /…
- Trial name
- NCT00460278
- Testing
- XL418
- Where
- 2 sites in United States
- Volunteers
- 63 people
- Sponsor
- Exelixis
Relapsed/Refractory Acute Myeloid Leukemia
Study Evaluating Safety and Efficacy of UCART123v1.2 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Phase I, open-label, dose-escalation and dose-expansion study evaluating the safety and efficacy of Universal Chimeric Antigen Receptor T-cell (UCART) targeting the Cluster of Differentiation 123 (CD123) in patients with…
- Trial name
- AMELI-01 (NCT03190278)
- Testing
- UCART123v1.2
- Where
- 8 sites in United States
- Volunteers
- 29 people
- Sponsor
- Cellectis S.A.
HIV Infections
Safety and Tolerability of PRO 140 in HIV Uninfected Male Volunteers
The purpose of the study is to determine the safety and tolerability of PRO 140, an investigational anti-HIV drug, administered via intravenous infusion.
- Trial name
- NCT00110591
- Testing
- PRO 140
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- CytoDyn, Inc.
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